- Cardiac Safety
- Suicide Risk Assessment
- Respiratory Solutions
- Insights Cloud
- Clinical Outcome Assessments/ePRO
Use of Concentration-effect Modelling for Cardiac Safety ECG Assessments, Kleiman, R.
Journal for Clinical Studies, October 2016 – ICH E14 Q&A (R3) provide exciting new options for drug developers by allowing the use of Concentration-effect Modelling (CEM), and thus potentially ascending dose ECG data, for the assessment of the electrocardiographic effects of a new drug. This article reviews the use of CEM for cardiac safety data in early-phase trials and details how it has the promise to increase the speed and reduce the overall cost of drug development.
A Novel Approach to QTc Studies: Assessing Cardiac Safety of the mTOR Kinase Inhibitor CC-223 within the Dose-Escalation/Expansion Study; Kleiman, R., Chopra, R., Hans, D., Heg, K., James, A., Wang, X., Wu, X., O’Mara, E.
Blood: 126 (23), December 2015 – QTc studies are usually performed with healthy volunteers but may be performed in the targeted patient population if the toxicity profile of a drug precludes its use in healthy individuals. Early-phase oncology dose-escalation studies generally include PK/PD evaluations from relatively large patient populations, which could provide a robust data set for concurrent cardiac safety evaluation. We have combined these approaches and present the results from a first-in-human phase 1 study of CC-223, a potent and selective dual inhibitor of mechanistic target of rapamycin (mTOR) kinases.
In Oncology Trials, Every Subject Counts; Kleiman, R.
Applied Clinical Trials, December 2015 – This article reviews how sponsors of oncologic clinical trials can prevent unnecessary subject exclusions with high precision ECG analysis generated through centralized cardiac safety measurement.
A Thorough QT Study To Evaluate the Effects of Therapeutic and Supratherapeutic Doses of Delafloxacin on Cardiac Repolarization – By Litwin, J., et. al.
Antimicrobial Agents and Chemotherapy, June 2015 – This randomized, double-blind, placebo-controlled, 4-period crossover study in healthy volunteers evaluated the effect on the QTcF interval of i.v. delafloxacin administered at both therapeutic (300-mg) and supratherapeutic (900-mg) doses. The principal finding is that neither of the 2 delafloxacin dose groups demonstrated an upper bound that approached or exceeded 10 ms, indicating no clinically meaningful increase in the QTcF interval.
Moxifloxacin-induced QTc interval prolongations in healthy male Japanese and Caucasian volunteers: a direct comparison in a thorough QT study – By Morganroth, J., Wang, Y., et al
British Journal of Clinical Pharmacology, July 2015 – Studies with quinidine and levofloxacin suggest inter-ethnic differences in QT sensitivity, which, if applicable to moxifloxacin, may adversely affect establishing assay sensitivity in some thorough QT studies. This paper reviews a study that investigated whether moxifloxacin-induced QTc prolongations in Japanese and Caucasian healthy male volunteers were significantly different. It demonstrated no statistically significant differences between the two populations studied.
Poster presented at the American Society for Clinical Pharmacology and Therapeutics (ASCPT) Annual Meeting, March 8, 2016, San Diego, CA.
Benefits of Centralized ECG Reading in Clinical Oncology Studies – By Kleiman, R., Litwin, J., Morganroth, J.
Therapeutic Innovation & Regulatory Science, August 2015 – This study compared digital ECG machine QTc measurements with those obtained by a centralized ECG core lab on more than 270,000 consecutive ECGs collected from 299 clinical oncology trials/ It found very significant discrepancies which may have important implications for patient recruitment for clinical oncology trials as well as for patient safety during dosing with new oncologic agents.
Poster presented at the American Society for Clinical Pharmacology and Therapeutics (ASCPT) Annual Meeting, March 8, 2016, San Diego, CA.
A Thorough QT Study Designed to Assess the Effects of Tbo-filgrastim on Cardiac Repolarization in Healthy Subjects – By Adar, N., Avisar, L., Lammerick, A., Kleiman, R., Spiegelstein, O.
Journal of Drug Design, Development and Therapy, May 2015 – This article reviews a study conducted by a global pharmaceutical company to establish the cardiac safety profile of tbo-filgrastim, which demonstrated no signal for any tbo-filgrastim effect on TQc or other electrocardiogram parameters.
The Use of Ambulatory Blood Pressure Monitoring in Drug Development
Copyright, January 2015 – How is Ambulatory Blood Pressure Monitoring (ABPM) leveraged in clinical trials? This white paper delves into the basics of blood pressure and why we measure it, along with the well-documented limitations of standard and digital office blood pressure measurements. ABPM device functionality is detailed, as well as example ABPM recordings and activity records. The paper reviews common drug classes where blood pressure monitoring comes into play and compares the advantages and disadvantages of different monitoring options in clinical studies.
The Use of Continuous ECG Recordings (Holters) in Drug Development
Copyright, December 2014 – Continuous 12 lead ECG recorders, often referred to as Holter devices, offer specific advantages to be considered over the standard 12 lead ECGs often collected during clinical trials for cardiac safety. This white paper explores the history of Holters, how sponsors, sites, and patients use these devices, and the benefits of continuous ECG recordings.
A Primer on Collecting Cardiac Safety Data during Drug Development; Kleiman, R.
Copyright, November 2014 – This whitepaper reviews how ECGs are generated, the various features of modern ECG machines, what data ECGs provide in clinical trials for cardiac safety, and how ECG tracings are interpreted differently by machines, investigation sites, and centralized labs. A detailed comparison of data quality in clinical trials is provided between paper ECGs collected by sites and digital ECGs collected on standardized machines by a centralized lab.
ICH E14 Q&A(R2) Document: Commentary on the further updated recommendations on thorough QT studies – By Kleiman, R., Shah., R., Morganroth, J.
British Journal of Clinical Pharmacology, 2014 – The ICH E14 Implementation Working Group (IWG) released a third set of Questions-and-Answers (Q&A) documents to clarify some areas of uncertainty or to take account of emerging science and technology. In this publication, the authors provide comments based on this document including ECG methodology, concentration-response modelling and TQT studies in special cases such as fixed dose combinations, orphan drugs, biologic therapeutic proteins and chirally active drugs.
Replacing the Thorough QT Trials: Reflections of a Baby in the Bathwater – By Kleiman, R., Shah., R., Morganroth, J.
British Journal of Clinical Pharmacology, August 2014 – This article reviews the current paradigm – and consequent dilemma – related to evaluating a drug’s effect on QT interval. In it, the authors present the rationale for and criticisms of the TET-based strategy outlined in ICH E14 and propose replacements for the standard TET study.
Why is Cardiac Safety Testing Required for Non-Cardiac Drugs? – By Robert Kleiman, M.D.
Copyright, August 2014 – This whitepaper provides an introduction to the requirement for cardiac safety data collection, regardless of the new chemical entity’s (NCE’s) indication, as well as an overview of the regulatory landscape; including Thorough QT Trials (TQTs) as recommended by the ICH E14 guidance, and other strategies for complete cardiac safety testing.
Quantitative T-Wave Morphology Analysis: A New Method for Evaluating Risk of Proarrhythmia Key Benefits – By Robert Kleiman, M.D.
Copyright, July 2014 – This whitepaper provides a brief introduction to the clinical problem with drug induced ventricular proarrhythmia, an overview of the current use of the QTc biomarker and its shortcomings, and an in-depth look into a new method, Quantitative T-wave Morphology Analysis (QTWMA), used to evaluate the risk of proarrhythmia in clinical development.
Electrocardiographic assessment for therapeutic proteins
American Heart Journal, October 2010 – This paper summarizes scientific discussions of members of the Cardiac Safety Research Consortium and includes possible approaches to consider for the clinical evaluation of drug-induced QT prolongation in development programs of therapeutic proteins.
Evaluation of ventricular arrhythmias in early clinical pharmacology trials and potential consequences for later development
American Heart Journal, May 2010 – This white paper, prepared by members of the Cardiac Safety Research Consortium, discusses several important issues regarding the evaluation of ventricular arrhythmias in early clinical pharmacology trials and their potential consequences for later clinical drug development.
Tufts Cardiac Safety Report – By Stergiopoulos, Feldman and Getz
Tufts University, March 2010 – The centralization of support services has frequently offered sponsors, CROs and investigative sites economies of scale and efficiency, enhanced coordination, shorter cycle times, and a higher standard of data quality, often at a reduced cost.
Assessing Suicidality in Clinical Trials: Paxil’s Wakeup Call
Applied Clinical Trials, September 2015 –The recent news regarding Le Noury and colleagues’ re-analysis of a 14-year old study demonstrating the safety of paroxetine (Paxil) in children and teenagers (2015; British Medical Journal) made national headlines and caused a stir about how drug manufacturers evaluate and document the safety and efficacy of new drugs.
Electronic Assessment of Suicidal Ideation and Behavior for Meta-Analyses across Multiple Trials and Treatment Indications
International Society for CNS Clinical Trials Methodology Presented Poster, February 2013 – The study compared patient-reported suicidal ideation and behavior at baseline and prospectively during trial participation. Neurological and non-CNS studies found similar prevalence rates of SIB, which were substantially less than the rates self-reported by psychiatric patients.
Interactive Voice Response and Tablet Self-Report Versions of the Electronic Columbia-Suicide Severity Rating Scale are Equivalent
CNS Summit Presented Poster, November 2014 – This study examined the equivalence of scores obtained from the IVR version of the eC-SSRS and a patient-reported version that was administered on a tablet device. The results support the validity and reliability of the new tablet-based eC-SSRS and will allow its inclusion in a wider range of clinical studies.
Predictive Value of Baseline electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) Assessments for Identifying Risk of Prospective Reports of Suicidal Behavior During Clinical Research
Innovations in Clinical Neuroscience; November 2014 – This meta-analysis examined the ability of baseline eC-SSRS lifetime suicidal ideation and behavior categories to predict prospective reports of suicidal behavior in psychiatric and non-psychiatric research participants. The review of over 74,000 eC-SSRS assessments determined that increasingly more severe lifetime suicidal ideation at baseline was associated with a progressively greater likelihood of prospectively reported suicidal behavior during study participation.
Predictive Value of eC-SSRS Suicide Risk Assessment Questions during Psychiatric and Non-Psychiatric Clinical Trials based on Lifetime Reports of Suicidal Ideation and Behavior at Baseline
CNS Summit Presented Poster, November 2013 – This study analyses the records of psychiatric and non-psychiatric patients with lifetime baseline and prospective assessments of SIB during clinical trials to identify the short-term predictive value for suicidal behaviors. Lifetime suicidal ideation or behavior or both at baseline significantly increases risk of prospectively reporting suicidal behavior during remaining clinical trial participation.
Comparing Clinician-rated C-SSRS with Computer-administered eC-SSRS (Ver 2.0): Replication and Extension of Prior Research Findings
ISCTM Conference Presented Poster, October 2013 – This study replicates and extends prior validation results of the eC-SSRS (Ver 1.6). In general, this study found comparable agreement between the revised eC-SSRS (Ver 2.0) and both clinician-rated C-SSRS assessments as was evident between the two experienced, well-trained C-SSRS raters.
Prediction of Suicidal Behavior in Clinical Research by Lifetime Suicidal Ideation and Behavior Ascertained by the Electronic Columbia-Suicide Severity Rating Scale – By J. Mundt, J. Greist, J. Jefferson, M. Federico, J. Mann, and K. Posner
Journal of Clinical Psychiatry: September 2013 – To evaluate whether lifetime suicidal ideation with intention to act and/or suicidal behaviors reported at baseline predict risk of prospectively reporting suicidal behavior during subsequent study participation. Data from studies using the electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) to prospectively monitor suicidal ideation and behaviors between September 2009 and May 2011 were analyzed.
Risk of Prospective Suicidal Behavior Reports among Psychiatric and non-Psychiatric Patients using Lifetime Reports at Baseline – By Dr. James Mundt et al
International Society for CNS Trials and Methodology Presented Poster, February 2013 – Baseline reports of a lifetime history with suicidal ideation with an intention to act, prior suicidal behaviors, or both, significantly increase patient risk for prospectively reporting suicidal behavior during study participation. Reports of such are higher among psychiatric patients; however, the increased risk conveyed by the lifetime assessments also generalizes to non-psychiatric patients.
Electronic Assessment of Suicidal Ideation and Behavior for Meta-Analyses across Multiple Trials and Treatment Indications – By Dr. John Greist et al
International Society for CNS Trials and Methodology Presented Poster, February 2013 – Neurologic and non-CNS studies found similar prevalence rates of SIB using the eC-SSRS at baseline and prospectively during study participation. These rates were substantially less than the suicidal ideation and behavior rates self-reported by psychiatric patients. Although less frequent, positive findings were a substantial safety concern in these non-psychiatric trials.
eC-SSRS Assessments of Lifetime Ideation and Behavior are Predictive of Suicidal Behaviors Occurring During Trial Participation
International Society for CNS Trials and Methodology Presented Poster, October 2011 – Safety concerns regarding suicidality in clinical trials resulted in the release of FDA draft guidance in September, 2010.
Feasibility and validation of a computer-automated Columbia-Suicide severity rating scale using interactive voice response technology – By Dr. James Mundt et al
Journal of Psychiatric Research, December 2010 – This peer-reviewed article evaluates a computer-automated version of the Columbia-Suicide Severity Rating Scale (C-SSRS) using interactive voice response technology (eC-SSRS). In essence, the reliability and validity of the C-SSRS and eC-SSRS for assessing suicidal ideation and behaviors in clinical trials or clinical care were comparable in this first study comparing the methods.
Electronic Administration of the C-SSRS (eC-SSRS): Results from 14,937 Administrations
International Society for CNS Trials and Methodology Presented Poster, October 2010 – Concern about possible treatment-emergent suicidality has prompted the FDA to issue draft guidance for prospective assessment of suicidality in clinical trials.
Validation of an Electronic Columbia-Suicide Severity Rating Scale using Interactive Voice Response Technology
NCDEU Presented Poster, June 2010 – A computer-automated version of the Columbia–Suicide Severity Rating Scale (eC-SSRS) using interactive voice response technology was evaluated.
FDA Includes First PRO Measure for COPD
Applied Clinical Trials, October 2016 – This article reviews current regulatory trends and challenges sponsors face in developing new treatments for COPD, including updates from U.S. FDA’s May 2016 update to its draft guidance on developing COPD drugs.
The Predictors for COPD Exacerbations using Remote Patient Monitoring; Sirichana, W., Wang, X., Taylor, M., Barjaktarevic, I., Cooper, C.
Poster presented at European Respiratory Society, September 2015 – This prospective demonstrated the feasibility of Remote Patient Monitoring in COPD patients at home and identified predictors of exacerbations that could be deployed in future health maintenance programs.
Choices of Spirometry Measures for Remote Patient Monitoring in COPD – By W. Sirichana, M.H. Patel, X. Wang, M. Taylor, I. Barjaktarevic, E.C. Kleerup, C.B. Cooper
ATS Presented Poster, May 2014 – This poster presents findings from the UCLA CLEAR study, comparing the repeatability and feasibility of forced and slow spirometry for Remote Patient Monitoring of COPD.
Limits of the Correlation of Wrist-worn Accelerometry with Oxygen Uptake – By W. Sirichana, K. Sail, M. Taylor, X. Wang, I. Barjaktarevic, E.C. Kleerup, C.B. Cooper
ATS Presented Poster, May 2014 – Anticipating a correlation between body movement and oxygen uptake (VO2), we can perhaps use accelerometers to indirectly measure VO2 or to quantify daily physical activities in terms of metabolic equivalents (METs). Reliability of this approach remains unclear especially at higher activity level. We aimed to test the reliability of a tri-axial accelerometer in the measurement of VO2 over a range of daily physical activities.
Daily Physical Activity in COPD: Quantification by Tri-axial Accelerometry by Sirichana W1, Moore-Gillon CER, Patel MH, Taylor M, Storer TW, Cooper CB
ATS Conference Presented Poster, May 2013 – This poster reviews the development of a networked measurement system for the classification and quantification of physical activity in COPD, as no standard method currently exists.
Feasibility of Remote Monitoring of Physiology and Symptoms in COPD Patients by Sirichana W., Moore-Gillon CER, Patel MH, Abrazado M, Tseng C-H, Taylor M, Cooper CB
ATS Conference Presented Poster, May 2013 – This poster reviews the development of a networked system for remote physiological monitoring (RPM) at home with the aim of detecting COPD exacerbations, facilitating earlier interventions and reducing health related expenditures.
Prediction of peak flow values followed by feedback improves perception of lung function and adherence to inhaled corticosteroids in children with asthma – By J. Feldman, H. Kutner, L. Matte, M. Lupkin, D. Steinberg, K. Sidora-Arcoleo, D. Serebrisky, K.
Thorax, November 2012 – This article shows that feedback on PEF predictions for ethnic minority, inner-city children may decrease underperception of respiratory compromise and increase adherence to controller medications. Children and their families may shift their attention to asthma perception and management as a result of this intervention. This study used ERT’s AM2 electronic spirometer and eDiary for PEF data collection.
Inter-visit Variability of Spirometry and Diffusion in a Worldwide Multicenter Clinical Trial with Moderate to Severe COPD patients
ATS Conference Presented Poster, April 2011 – The aim of this work was to evaluate the repeatability of slow and forced spirometry and diffusion parameters between run-in visits in a worldwide clinical trial with moderate to severe COPD patients.
Intra-visit Repeatability of Slow Spirometry in a Worldwide Multicenter Clinical Trial with Moderate to Severe COPD patients
ATS Conference Presented Poster, April 2011 – The aim of this work was to evaluate the repeatability of VC and IC in a worldwide clinical trial with COPD patients and compare with these criteria.
Five Reasons Why You Should Embrace the ICH E6 (R2) Addendum Now; Regan, B.
Copyright, December 2016 – In November 2016, the ICH E6 (R2) addendum to Good Clinical Practice was implemented, delivering a breath of fresh air for clinical trial sponsors and CROs who have been looking for guidance on best practices for achieving true, risk-based quality management during clinical development.
The ICH Addendum is expected to formalize trial process guidelines that will have a positive impact on data quality, so there’s no reason to wait to implement these guidelines. By embracing the Addendum now, sponsors and CROs not only stay ahead of guidelines and regulations, but also reap significant benefits across many aspects of clinical development.
Game Changer; Neri, N.
This article is taken from European Pharmaceutical Contractor, November 2016, pages 4-7. © Samedan Ltd. – The new ICH E6 (R2) Addendum to Good Clinical Practice (GCP) has the potential to alter the way clinical monitoring and trial management are conducted – by making the adoption of centralized quality risk management (QRM) throughout the study lifecycle an integral part of their recommendations. This article reviews the Addendum and provides 6 steps organizations can take to ensure compliance.
A Relationship Driven By Technology: How Sponsors And CROs Can Improve Collaboration
October 2016 – This article, published on ClinicalLeader.com demonstrates how the combination of robust technology and collaborative relationships between sponsors and CROs can drive better, faster clinical trial results.
Top 5 Considerations for Enhancing Trial Oversight
September 2016 – Current clinical systems and analytics platforms lack the comprehensive feature-set needed to support next generation risk based trial management. However, clinical trial sponsors and CROs do not necessarily have to completely overhaul their
existing systems in order keep up.
This paper explores what sponsors and CROs can do to complement and enhance their current systems to ensure they support their risk based monitoring (RBM) goals and enable them to proactively identify risks as they arise during clinical development.
Complying with the ICH E6 (R2) Addendum: Six Steps to Ensuring Risk-based Quality Management; Neri, N.
Copyright, May 2016 – For the first time in more than two decades, the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) has made a substantial change to its international guidelines, and biopharmaceutical leaders need to pay attention. The new E6 (R2) addendum to Good Clinical Practice has the potential to change the way clinical monitoring and trial management are conducted by requiring adoption of centralized, quality risk management (QRM) throughout the trial lifecycle. This White Paper provides an overview of the ICH changes, how risk based monitoring has evolved to meet regulatory expectations, and the key steps trial sponsors and CROs should take in order to be compliant once the addendum takes affect this fall.
Optimizing Trial Oversight through Centralized Data Surveillance; Regan, B.
DIA Global Forum, April 2016 – To better manage clinical trials, sponsors and CROs must overcome the data fragmentation challenge that has arisen from the use of multiple, disparate data capture technologies. This article reviews how cloud-based technology is de-fragmenting the eClinical ecosystem and delivering key business analytics that optimize trial oversight to help all trial stakeholders meet evolving industry demands.
Centralized Data Surveillance: Enabling Real-Time Risk Based Monitoring in Clinical Trials; Regan, B.
January 2016 – This White Paper presents the case for a new data-driven paradigm in clinical research in which multiple data points are viewed holistically, delivering real-time oversight of investigative sites, studies, and programs for improved trial management.
20 Most Promising Data Integration Solution Providers 2015
CIO Review, December 2015 – ERT, the leading cloud platform solutions provider delivering clinical and scientific innovation through its patient-centric data collection and intelligence solutions, today announced it has been named one of the 2015 20 Most Promising Data Integration Solution Providers by CIO Review. The annual list of companies is selected by a panel of experts and members of CIO Review’s editorial board to recognize and promote technology entrepreneurship.
Journal for Clinical Studies ePRO Q&A, Sullivan, R.
ePRO Q&A, Journal for Clinical Studies, December 2016 – Significant growth opportunities in the ePRO field mean the industry is calling out for solutions, advice and guidance that can help deliver on its promises. In this article, insights on some of the industry’s most pressing questions surrounding this expanding market are shared by industry experts, including ERT’s Ron Sullivan.
Just say ‘No’ to Paper Back-ups: Scientific rationale for optimizing electronic clinical outcome assessments in clinical trials, Dallabrida, S.
Applied Clinical Trials, November 2016 – The benefits of capturing high quality clinical trial data via eCOA has been widely recognized for more than a decade. However, some study teams who are new to eCOA occasionally raise questions about whether to use paper forms as a back-up in case of electronic data collection failure. In this article, evidence is presented to illustrate that paper back-up provisions are unnecessary and do not provide the desired benefits.
Subjects with osteoarthritis can easily use a handheld touch screen electronic device to report medication use: qualitative results from a usability study; Khurana, Ll, Durand, M., Gary, S., Otero, A., Gerzon, M., Beck, J., Hall, C., Dallabrida, S.
Patient Preference and Adherence, October 2016 – The validation of electronic patient reported outcome devices requires information on patient preference and ease of use. This study conducted usability testing for a General Symptom Questionnaire and Medication Module™ on a handheld device, concluding that they were usable and acceptable to subjects with osteoarthritis (OA). This was consistent regardless of previous experience and confidence with technology, despite the potential physical restrictions for an OA cohort.
PROMIS® tools as endpoints in clinical trials: what should you know? A review of PROMIS® capabilities and the current regulatory space; Shaloub, H., Reaney, M.
International Journal of Clinical Trials, November 2016 – NIH funded PROMIS measures are increasingly at the forefront of discussions in clinical trial endpoint measurement. This paper provides an overview of the PROMIS tools, how and when they can be used, how they are scored, what modalities exist and what considerations one should make before choosing to use a PROMIS instrument.
Think you Know Trial Patients’ eCOA Preferences? Think again…; Dallabrida, S.
Copyright October 2016 – This paper provides answers to the question,“What do patients want when interacting with electronic Clinical Outcome Assessments (eCOA) during a clinical trial?” Based on a survey of over 400 trial patients, the learnings indicate that even very simple changes in study design and user interface can go a long way toward adding a more human quality to the use of eCOA and promoting patient engagement during clinical trials.
Smart Thinking: How Wearables can Enhance Patient Data Collection during Clinical Trials; Khurana, L., Beckstrom, K.
European Pharmaceutical Manufacturing, September 2016 – There is increasing interest in incorporating data from wearable devices (activity and sleep trackers, heart rate monitors, smart watches) into clinical trials. This article presents the scientific and operational factors clinical trial sponsors should consider when using them in clinical development.
Content Validity for the VVSymQ Instument: A New Patient-Reported Outcome Measure for the Assessment of Varicose Veins Symptoms; Jean Paty, Celeste Elash, Diane Turner-Bowker
The Patient, July 2016 – Varicose veins are common and can impact patients’ quality of life, but consensus regarding the evaluation of varicose vein symptoms is lacking and existing measures have limitations. This research aimed to develop and establish the content validity of a new electronic patient-reported outcome (PRO) measure, the VVSymQ® instrument, to assess symptoms of superficial venous insufficiency (varicose veins) in clinical trials.
The Three P’s of Successful eCOA Implementation: People, Processes, and Plan; Eek, D., Hall, C., Hooper, S., Wald, F., Wurm, M.
International Pharmaceutical Industry, July 2016 – Adopting an eCOA strategy and subsequently implementing it requires an effective collaboration between clinical trial teams, eCOA providers and COA experts familiar with transitions from paper-based COA data collection. Here we review how to implement an eCOA strategy, and detail the people, process and products required for successful eCOA strategy implementation.
Patient Reported Outcomes (PROs) used in recent Phase 3 trials for Type 2 Diabetes: A review of concepts assessed by these PROs and factors to consider when choosing a PRO for future trials; Reaney, M., Elash, C., Lichter-Kelly, L.
Diabetes Research and Clinical Care, June 2016 – This literature review was conducted in multiple databases to identify PRO endpoints used in Phase 3 trials of newer classes of drugs for the treatment of T2D. It concludes that the information gained from using PROs in clinical trial research is important in defining treatment benefit within the context of the trial, and the potential benefit (i.e. better adherence) in clinical practice.
eCOA Increases Patient-Site Communication and Candor; Dallabrida, S.
Copyright, March 2016 – In this White Paper, a wealth of scientific literature is presented to demonstrate how electronic Clinical Outcome Assessments (eCOA) increase patient/clinician communication & candor and improve overall patient care while mitigating site rater variability, as compared to traditional paper-based COA approaches.
Using ePRO for the First Time: Lessons Learned; Turner, D.
Copyright, March 2016 – This White Paper discusses the benefits of using ePRO, lessons learned from first time use, and how to plan for successful trials.
Which collection method for COA data will best support your trial, Paper or eCOA?
2016 – This poster explores the decision making process behind choosing paper or eCOA for use in clinical trial data collection.
Optimizing Electronic Clinical Outcome Assessment Materials Required for IRB/IEC Review; Raymond, S., Gertel, A., Barrasso, B., Hackett, A.
Medical Research Law & Policy, March 2016 – This article reviews current ethics committees’ processes for reviewing electronic clinical outcome assessments (eCOA) – including diaries and questionnaires – used to gather data from patients in clinical trials, detailing how this process can be adequately supported by examination of the English versions on paper.
Reproduced with permission from Medical Research Law & Policy Report, 15 MRLR 159 (Mar. 2, 2016). Copyright 2016 by The Bureau of National Affairs, Inc. (800-372-1033) <http://www.bna.com>.
Therapeutic Success or Failure: A Journey, Not Just a Destination; Reaney, M., Raymond, S.
Applied Clinical Trials, February 2016, Vol 25, Issue 2 – As the medical community moves toward individualized and tailored therapeutics, and pharmaceutical companies are increasingly opting into risk-sharing agreements with payers, it is important to understand the patient journey with a medication, as well as the goal achievement of that medication. This article reviews how collecting routine and regular outcome data in pharmacotherapy development programs allows an understanding of the true impact of the medication in that context.
Adding Value; Raymond, S., Reaney, M.
European Pharmaceutical Contractor, February 2016, pages 14-15. © Samedan Ltd – This article reviews the role electronic Clinical Outcome Assessments (eCOA) can play in emerging value priced drug strategies, offering benefits to product developers, payers, and patients.
ERT opening Innovation Lab in Boston; Chontos, L.
CenterWatch Weekly, February 2016 – The Innovation Lab was designed as a physical space to foster collaboration between leading technology providers, pharmaceutical researchers and ERT clinical scientists to develop diverse technologies. Its goal is to reduce risk while exploring possibilities for improving pharmaceutical research, specifically creating new and efficient ways to collect and use patient-centric data. Founded on principles of lean development, the Lab is meant to yield results in weeks rather than months.
Patient-Centered Reasons for Primary Non-Adherence (Medication Non-Fulﬁllment) as Derived from the Peer-Reviewed Literature; McHorney, C.
ISPOR EU Presented Poster, November 2015 – This study examined primary non-adherence (PNA), which occurs when patients fail to fill a newly-prescribed medication. If we are intervene to reduce PNA, doctor-patient communication at the time of prescribing must be improved and address patients beliefs about the need for the medication.
Review of Adherence Measures for Use in Phase IV Studies and Recommendations for a New Standardized Generic Measure; McHorney, C. & Reaney, M.
ISPOR EU Presented Poster, November 2015 – This study examined medication adherence in the public domain, citing multiple metrics for measuring the adherence in Phase IV studies.
Clinical Outcome Assessments: Conceptual Foundation—Report of the ISPOR Clinical Outcomes Assessment – Emerging Good Practices for Outcomes Research Task Force; Walton, M., et. al.
Value in Health, 2015 – This is the first of two reports by the ISPOR Clinical Outcomes Assessment – Emerging Good Practices for Outcomes Research Task Force. This report provides foundational definitions important for an understanding of COA measurement principles.
Driving Change Through eCOA Innovation; Munz, J.
Applied Clinical Trials, October 2015 – The eBook explores important considerations and current trends related to capturing Clinical Outcome Assessment (COA) – especially electronic Patient Reported Outcomes (ePRO) – data in clinical trials. This particular chapter focuses on the possibilities of ePRO in the near future, including examples of how ERT Innovation Lab concepts are actively improving electronic patient data collection
Patient’s Voice Finally Being Heard in Diabetes Drug Research; Reaney, M., Applied Clinical Trials
Applied Clinical Trials, August 2015 – In this ‘Closing Thought’ article, the author reviews the significance of the European Medicines Agency’s recent approval of Trulicity® for Type 2 Diabetes Mellitus, which included a first-in-class label claim pertaining to treatment satisfaction. Eli Lilly was able to secure the claim based on the strategic use of patient reported outcomes (PRO) data collected during clinical development.
“Bring Your Own Device: Smart Thinking” – by, Dallabrida, S.M., Beckstrom, K., International Clinical Trials
July/August 2015 – This article reviews the emerging trend of using a Bring Your own Device (BYOD) approach for collecting Clinical Outcome Assessment (COA) data in clinical trials, reviewing the advancing conversation and ongoing research to address sponsors’ questions.
The VVSymQ instrument: Use of a new patient-reported outcome measure for assessment of varicose vein symptoms – by, Paty, J., Turner-Bowker, D., Elash, C., Wright, D.
Journal of Phlebology, July 2015 – This article reviews the development and validation of a new patient reported outcome instrument which focuses solely on assessment of varicose veins symptoms that are bothersome to patients.
Are patient-reported outcome instruments for ankylosing spondylitis fit for purpose for the axial spondyloarthritis patient? A qualitative and psychometric analysis – by, Tubergen, A., Black, P., Coteur, G.
Journal of Rheumatology, May 2015 – Several patient-reported outcome (PRO) instruments have been validated in AS. This article reviews a study which evaluated several measurement properties of Patient Reported Outcomes (PRO) instruments in a broad axial SpA (axSpA) population, demonstrating that both content validity and measurement properties of PRO instruments utilized in AS are preserved in the broad axSpA population.
BYOD for Clinical Trials: Fact v. Fiction; Rocchio, S.
CenterWatch Monthly, May 2015 – This blog post addresses the Bring Your Own Device (BYOD) approach for collecting Clinical Outcome Assessment (COA) data in clinical trials. It presents some of the benefits and issues sponsors might consider before adopting BYOD and stresses the importance of flexible solutions and options for patient-driven data collection.
Case Study Evidence: Reduced Standard Deviation With Electronic PRO –
In 2004, clinical researchers at Merck Research Laboratories designed a study to compare and evaluate patient-reported outcome (PRO) data collected on a handheld electronic device vs data collected on paper. To this day, the Merck Insomnia Study is widely cited as evidence for comparative equivalence and a reduced standard deviation for electronic diary data as compared to paper data.
Why Rater Training Matters in Clinical Trials: A Science Overview; Hall, C. & Dallabrida, S.
Clinical Leader, March 2015 – Rater training is recommended by many instrument owners to ensure uniform completion and use of the measure, increase signal and reduce noise for improved statistics. This article reviews how a standardized technique, interpretation and recording of rater training can improve data accuracy.
eDiary System’s Importance in a Clinical Trial for Female Sexual Dysfunction; Rocchio, S.
Applied Clinical Trials, March 2015 – This case study presents Palatin Technologies’ use of an electronic Diary in a Ph IIB study of bremelanotide for the treatment of Female Sexual Dysfunction. It reviews Lessons Learned and how capturing Patient Reported Outcomes data electronically (ePRO) provided patients privacy and anonymity, which is vital to the success of studies in which sensitive data are collected.
One Program, Four Stakeholders: An Overview of the Utilization of Patient-Reported Outcomes in Intervention Development to Meet the Needs of Regulators, Payers, Healthcare Professionals and Patients
Pharmaceutical Medicine, March 2015 – This article briefly summarizes the perspectives of regulators, payers, HCPs and patients regarding PRO endpoints, and examines how a robust, comprehensive and systematic PRO endpoint strategy can be developed to meet the needs of all stakeholders in a single development program.
Best Practices for Streamlining Electronic Implementation of Established COAs
Copyright, January 2015 – This paper addresses the best practices for building an electronic Clinical Outcome Assessment (eCOA) solution in support of clinical research as it relates to the operational and licensing compliance aspects of administering COAs on electronic platforms.
Symptoms and Impact of COPD Assessed by an Electronic Diary in Patients with Moderate-to-Severe COPD: Psychometric Results from the SHINE Study
International Journal of COPD; January 2015. This paper presents the results of psychometric assessment data from a COPD eDiary devel¬oped by Novartis to provide a more detailed assessment of symptom frequency and severity and their impact on patients with COPD.
A Systematic Method for Selecting Patient-Reported Outcome Measures in Diabetes Research
Diabetes Spectrum; November 2014 – In this article, the authors present how PROs can be used effectively during clinical development of new diabetes treatment to help drug developers better understand the patients’ understanding, engagement, and commitment to the prescribed treatment strategy.
Interactive Voice Response and Tablet Self-Report Versions of the Electronic Columbia-Suicide Severity Rating Scale Are Equivalent
CNS Summit Presented Poster, November 2014 – Prospective monitoring of suicidal ideation and behavior (SIB) is an FDA requirement in all CNS clinical trials. The interactive voice response (IVR) version of the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) – which is completed directly by patients, without a clinician interviewer – can be used to prospectively monitor SIB. These results in this poster support the validity and reliability of the new tablet-based eC-SSRS. This will allow the inclusion of the eC-SSRS in a wider range of clinical studies, particularly where a tablet is also being used to collect other patient-reported efficacy or safety data.
The Importance of Understanding the Impact of Preference in Clinical Trials of Diabetes Interventions – by Reaney, M.
Journal of Diabetes, August 2014 – This commentary aims to highlight the potential role of patient preference in trials of interventions of diabetes, a condition that is characterized by self-management, patient values guiding clinical decision making, and a wide array of treatment options. It reviews how measuring outcomes among subgroups of patients with different preferences and motivations may help clinicians apply the results of RCTs to their practices.
Measuring and Interpreting Patient-Reported Outcome Data from Clinical Trials of Diabetes Medication – by Reaney, M, Gwaltney, C.
Journal of Diabetes Research & Clinical Metabolism, July 2014 – Treatment of Type 2 Diabetes requires a progressive and multi-factorial approach that addresses clinical and psychosocial aspects of living with diabetes. This article reviews how, when taken together, efficacy, safety, and PRO data from clinical trials can assist in providing care that is in line with patient values and may, in turn, increase adherence in clinical practice.
A Novel Electronic Application of Patient-reported Outcomes in Multiple Sclerosis – Meeting the Necessary Challenge of Assessing Quality of Life and Outcomes in Daily Clinical Practice – By Exell, S., Thirstan, M., Dangond, F., Marhardt, K., St. Charles-K
European Neurological Review, May 2014 – This paper presents MSdialog, a novel web- and mobile-based software application for people who have Multiple Sclerosis and their health care providers (HCPs). MSdialog works with electronic auto-injector devices to collect and store treatment adherence data, as well as patient-reported outcome (PRO) and clinician-reported outcome (ClinRO) data. MSdialog may provide a practical solution to support patient-proactive engagements and self-management, patient-centered care, and participatory decision-making in clinical practice.
Patient Reported Outcome Data Collection via Bring Your Own Device (BYOD) Approach: Key Benefits and Considerations for Clinical Development – By Chad Gwaltney, PhD
Copyright, January 2014 – This white paper addresses the role of a Bring Your Own Device (BYOD) approach to electronic patient reported outcome (ePRO) data collection in clinical development. It presents questions researchers should consider before using BYOD in pre-labeling research and reviews how different ePRO methods of administration may or may not deliver equivalent results.
Electronic Clinical Outcome Assessments (eCOAs): Value of Site-Based Assessments
Copyright, January 2014 – Electronic Clinical Outcome Assessments (eCOAs) are collected on a frequent basis in the context of the patient’s daily life, or when the patient visits a clinic for a healthcare or clinical trial appointment. This paper discusses site-based clinical outcome assessments, and the considerations for successfully collecting patient data at the site.
Difference in method of administration did not significantly impact item response: an IRT-based analysis from the Patient-Reported Outcomes Measurement Information System (PROMIS) initiative – By Bjorner, J., Rose, M, Gandek, B., Stone, A., Doerte, U., Ju
Qualitative Life Research, 2013 – This study tested the impact of method of administration (MOA) on the measurement characteristics of items developed in the Patient-Reported Outcomes Measurement Information System (PROMIS), including structural invariance, equivalence of item responses, and measurement precision. It found no statistically or clinically significant differences in score levels in Interactive Voice Response (IVR), Paper Questionnaire, or handheld Personal Digital Assistant (PDA) administration as compared to Personal Computer.
eCOA Regulatory Inspections: Best Practices for Smooth and Successful Outcomes – By G. Craig
Copyright, October 2013 – This White Paper addresses the challenge of an eCOA inspection from a regulatory agency. Based upon our experience of supporting companies through such inspections across the globe, we outline the process and procedures that will facilitate a successful outcome. Our experience suggests that while each inspection is different, we have witnessed some common themes and collaborated with sponsors on responses that have worked successfully in answering regulators’ questions.
Item-Level Psychometric Properties for a New Patient-Reported Psoriasis Symptom Diary by Strober, B., Malya, U., Guettner, A., Papavassils, C., Gotlieb, A., Elewski, B., Turner-Bowker, D., Shields, A., Gwaltney, C., Lebwohl, M.
Value in Health: September 2013 – This article reviews the research Novartis Pharmaceuticals conducted to evaluate the psychometric properties of a new Psoriasis Symptom Diary, identify diary responder definitions for use in determining whether a patient has experienced clinically meaningful change, and refine diary item content for use in future clinical trials.
Validation of Electronic Systems to Collect PRO Data – Report of the ISPOR ePRO Systems Validation Good Research Practices Task Force – By A. Zbrozek, MSc, J. Hebert, G. Gogates, R. Thorel C. Dell, E. Molsen, G. Craig, K. Grice, S. Kern, S. Hines
Value in Health: June/July 2013 – This report was written to explain how the validation process works for sponsors, trial teams, and other users of electronic data collection devices responsible for verifying the quality of the data entered into relational databases from ePRO devices. It is a guide on the requirements and documentation needed from a data collection systems provider to demonstrate systems validation.
Clinical Outcome Assessments: Planning for Success
Copyright, June 2013 – COAs can support many strategic objectives from regulatory labeling to reimbursement. This white paper addresses the three primary parameters that must be defined to ensure adherence to the FDA’s 2009 PRO guidance. It also reviews the need to plan your COA strategy early on in the drug development process.
Development and Preliminary Validation of the Adult Asthma Adherence Questionnaire™ – By Michael Schatz, MD, MS, Robert S. Zeiger, MD, PhD, Su-Jau Yang, PhD, Andrew G. Weinstein, MD, Wansu Chen, MS, Renee N. Saris-Baglama, PhD, and Diane M. Turner-Bowker
Journal of Asthma and Clinical Immunology: In Practice, May 2013 – Asthma medication adherence is related to better asthma outcomes, but identification of suboptimal patient adherence behavior is not standardized in clinical settings. In this article, the authors present a study that identified five questions that can be used clinically to identify patients at risk of nonadherence and the specific adherence barriers involved to allow targeted intervention to improve adherence.
The Psoriasis Symptom Diary: development and content validity of a novel patient-reported outcome instrument
Chronic plaque psoriasis has a profound impact on a patient’s daily life. To understand the effects of psoriasis treatments, it is essential to assess the patient’s experience of symptoms and how they impact their daily life. The goal of this study was to develop and establish the content validity of a new patient reported outcome (PRO) psoriasis measure.
Evaluation of an Electronic Daily Diary for Measuring Morning Symptoms in Chronic Obstructive Pulmonary Disease – By Baldwin, Ml, Kulich, K., Tiplady, B., Gwaltney, C., Cline, J.
ATS Conference Presented Poster, May 2013 – Morning symptoms in Chronic Obstructive Pulmonary Disease (COPD) are a substantial burden to patients. Currently, there is no validated diary available to address morning core symptoms specifically. This poster reviews a daily electronic diary (eDiary) that has been developed on the basis of patient interviews to asses severity and bother caused by symptoms since awakening.
Cognitive Testing of the Investigator’s Global Assessment of Lateral Canthal Lines (LCL) Severity Scale – By Turner-Bowker, D., St. Charles-Krohe, M., Paty, J., Cline, J., Hall, S., Lee, J, Waugh, J.M,
ISPOR Conference Presented Poster, May 2013 – This poster presents the findings of a study that was designed to conduct cognitive interviews to assess clinician comprehension of, and reported ability to administer the Investigator’s Global Assessment of Lateral Canthal Line (IGA-LCL) severity scale for use in a clinical development program.
Development and Content Validity of an Endometriosis Patient Diary – By by Van Nooten, F., Paty, J., Elash, C., Turner-Bowker, D., Meyers, O., Holtkamp, G. Wilken, S., Boerrigter, G., Holmstrum, S.
ISPOR Conference Presented Poster, May 2013 – This poster reviews the development and validation of a daily electronic Patient Reported Outcomed (ePRO) diary for use in evaluating patients who experience pain due to endometriosis.
Identification of Cardinal Symptoms in Patients with Chronic Idiopathic Constipation – By A. Joslyn, L. Barrow, J. Paty
Digestive Disease Week, May 2012 – This poster reviews the process Synergy Pharmaceuticals went through in developing an instrument to collect daily Patient Reported Outcomes (PRO) data from CIC patients. [formerly an invivodata resource]
Measurement in Clinical Trials: Review and Qualification of Clinical Outcome Assessments – By FDA
FDA Public Workshop, October 2011 – The FDA hosted a workshop that will change how developers of medical products select, evaluate, and provide evidence to support endpoints for their clinical development programs. [formerly an invivodata resource]
Content Validity—Establishing and Reporting the Evidence in Newly Developed Patient-Reported Outcomes (PRO) Instruments for Medical Product Evaluation: ISPOR PRO Good Research Practices Task Force Report: Part 1—Eliciting Concepts for a New PRO Instrument
Value in Health, October 2011 – In this first of a 2-part ISPOR PRO Good Research Practices Task Force Report, the authors review the process for developing content and assessing respondent understanding of newly developed PRO instruments for medical product evaluation, specifically the elicitation of key concepts using qualitative focus groups and/or interviews to inform content and structure of a new PRO instrument.
Content Validity—Establishing and Reporting the Evidence in Newly Developed Patient-Reported Outcomes (PRO) Instruments for Medical Product Evaluation: ISPOR PRO Good Research Practices Task Force Report: Part 2—Assessing Respondent Understanding – By Pat
Value in Health, October 2011 – In this second of a 2-part ISPOR PRO Good Research Practices Task Force Report, the authors review the process for developing content and assessing respondent understanding of newly developed PRO instruments for medical product evaluation, specifically, the methods for conducting cognitive interviews that address patient understanding of items, instructions, and response options; and the methods for tracking item development through the various stages of research and preparing this tracking for submission to regulatory agencies.
Vendor Assessment: IDC Short List – 2010 Electronic Patient Reported Outcome eClinical Solutions – By Alan S. Louie, IDC Health Insights
IDC Health Insights, December 2010 – For life science companies looking to incorporate ePRO as part of their current and future clinical trials, IDC Health Insights has created a user short list guide that seeks to provide users with the ability to easily compare vendor capabilities based on different study requirements, producing custom ePRO vendor landscapes built on specific vendor needs and wants. [formerly and invivodata resource]
Testing the Usability of e-PRO Translations during Linguistic Validation
ISPOR, November 2010 – An instrument that was initially developed as a self-administered paper diary has now been adapted for use with an electronic device.
Electronic Patient Reported Outcomes (ePRO): Focus on Site-Based Assessments – By Brian Tiplady
Copyright, October 2010 – This paper discusses the second type of ePRO, site-based assessments, and the considerations for successfully collecting patient data at the site. [formerly an invivodata resource]
ePRO Regulatory Inspections: Best Practices for Smooth and Successful Outcomes – By G. Craig
Copyright, September 2010 – In this White Paper, members of ERT’s ePRO Inspection Team review our experiences in supporting and participating in ePRO regulatory inspections by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), specifically BfArM (German Federal Institute for Drugs and Medical Devices), and the Japanese Pharmaceutical and Medical Devices Agency (PMDA), and outline best practices for ensuring smooth regulatory inspections of ePRO data collection systems. [formerly an invivodata resource]
Age-Related Reduction in Daytime Sleep Propensity and Nocturnal Slow Wave Sleep – By Derk-Jan Dijk, John A. Groeger, Neil Stanley, Stephen Deacon
SLEEP, February 2010 – This paper investigates whether age-related and experimental reductions in SWS and sleep continuity are associated with increased daytime sleep propensity. [formerly an invivodata resource]
Use of Existing Patient-Reported Outcomes (PRO) Instruments and Their Modification – By Margaret Rothman, Laurie Burke, Pennifer Erickson, Nancy Kline Leidy, Donald Patrick, Charles D. Petrie
Value in Health, December 2009 – The ISPOR good research practices for evaluating and documenting content validity for the use of existing instruments and their modification – PRO Task Force Report. [formerly an invivodata resource]
Recommendations on Evidence Needed to Support Measurement Equivalence between Electronic and Paper-Based Patient-Reported Outcome (PRO) Measures
Value in Health, June 2009 – ISPOR ePRO Good Research Practices Task Force Report by Stephen Joel Coons, Chad J. Gwaltney, Ron D. Hays, J. Jason Lundy, Jeff A. Sloan, Dennis A. Revicki, William R. Lenderking, David Cella, Ethan Basch on behalf of the ISPOR ePRO Task Force [formerly an invivodata resource]
Multinational Trials—Recommendations on the Translations Required, Approaches to Using the Same Language in Different Countries, and the Approaches to Support Pooling the Data
Value in Health, June 2009 – The ISPOR Patient-Reported Outcomes Translation and Linguistic Validation Good Research Practices Task Force Report by Diane Wild, Sonya Eremenco, Isabelle Mear, Mona Martin, Caroline Houchin, Mary Gawlicki, Asha Hareendran, Ingela Wiklund, Lee Yee Chong, Robyn von Maltzahn, Lawrence Cohen, Elizabeth Molsen [formerly an invivodata resource]
Equivalence of Electronic and Paper and Pencil Administration of Patient Reported Outcome Measures: A Meta-analytic Review – By Gwaltney, C., Shields, A., Shiffman, S.,
Value in Health, 2008 – This paper provides a meta-analysis of 278 scales used in clinical research to determine the equivalence of electronic and paper administration of patient reported outcomes. Based on this extensive evidence, it concludes that paper- and computer-administered PROs are equivalent. [formerly an invivodata resource]
Electronic Diary (eDiary) Improves the Quality of Data Collection over Conventional Paper Diary in Patients with Symptomatic COPD – By Rogers, Katayama, Hufford, Campbell, Kling, Kaladas
American Thoracic Society Presented Poster, May 2006 – Prior to ONO Pharma making an investment in the use of electronic diaries for a clinical study in patients with COPD, a comparative nondrug study, was conducted that was identical in methodology to that of an original clinical study contrasting paper and electronic diary compliance performed by Arthur Stone and colleagues. [formerly an invivodata resource]
Correspondence Between Paper and Electronic Visual Analog Scales Among Adult Asthmatics – By Michael Hufford and Saul Shiffman
Copyright, 2001 – This validation study sought to examine the correspondence between paper and electronic versions of the same 3-item VASs. [formerly an invivodata resource]
Reflection Paper on the Regulatory Guidance for the Use of Health-Related Quality of Life (HRQL) Measures in the Evaluation of Medicinal Products – By European Medicines Agency
EMA, July 2005 – The scope of this reflection paper is to discuss the place that a health-related quality of life (HRQL), a specific type of PRO, may have in drug evaluation process and to give some broad recommendations on its use in the context of already existing guidance documents.
Pain Assessment in Patients With Fibromyalgia Syndrome – By David A. Williams, Michael Gendreau, Michael R. Hufford, Kimberly Groner, Richard H. Gracely, Daniel J. Clauw
Lippincott Williams & Wilkins, 2004 – This study was designed to compare 3 commonly used methodologies for assessing clinical pain during trials involving patients diagnosed with fibromyalgia syndrome. [formerly an invivodata resource]
Electronic Diaries and Questionnaires: Designing user interfaces that are easy for all patients to use – By Mikael Palmblad and Brian Tiplady
Kluwer Academic Publishers, 2004 – Good user interface design for ePRO systems aims to eliminate potential sources of bias, and to ensure that all types of patients can use the system and be comfortable with it with a minimum of training. [formerly an invivodata resource]
Assessment of Post-Surgical Recovery after Discharge using a Pen Computer Diary – By A. Begg, G.Drummond, B. Tiplady
Anaesthesia, November 2003 – Daily electronic diaries are an acceptable method of obtaining better information on the extent and duration of symptoms and other difficulties after discharge following surgery. [formerly an invivodata resource]
Signaling Does Not Adequately Improve Diary Compliance – By Joan E. Broderick, Joseph E. Schwartz, Saul Shiffman, Michael R. Hufford, Arthur A. Stone
Annals of Behavioral Medicine, October 2003 – The hypothesis being tested in this paper is that compliance with a paper diary protocol would be improved by using auditory signaling. [formerly an invivodata resource]
Measuring clinical pain in chronic widespread pain: selected methodological issues – By Michael Gendreau, Michael R. Hufford, Arthur A. Stone
Best Practice & Research Clinical Rheumatology, August 2003 – Data from a recent study that implemented an electronic diary for capturing real-time pain data are presented and reviewed in the context of methodological factors that can affect pain ratings. [formerly an invivodata resource]
Patient Compliance with Paper and Electronic Diaries – By Arthur A. Stone, Saul Shiffman, Joseph E. Schwartz, Joan E. Broderick, Michael R. Hufford
Controlled Clinical Trials, April 2003 – Compliance with paper diaries was examined with a paper diary and with an electronic diary that incorporated compliance-enhancing features. [formerly an invivodata resource]