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Monitoring Pulmonary Safety in Non-Respiratory Clinical Drug Trials

April 9th, 2015

Adverse pulmonary reactions to pharmacotherapy can occur if the lung serves as a route for the entry of inhaled therapeutics into the body to treat diseases -- or as a consequence of pulmonary toxicity associated with systemic drug exposure. Assessing pulmonary adverse effects of therapeutics has many challenges, and thorough monitoring throughout clinical trials is pivotal to identify any of these detrimental effects in patients. This webinar reviews the clinical manifestations of pulmonary drug reactions and how these can be monitored by current pulmonary function tests.

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A Primer on Medication Adherence: Nature, Extent, and Determinants of Non-Adherence and its Relationship to Patient Outcomes

March 31st, 2015

Medication non-adherence is a problem of international proportion that knows no geographic, demographic, or political boundaries. This webinar will: (1) review the nature and scope of non-adherence: (2) discuss the Ten Tenets of Medication Adherence and how they inform our knowledge of determinants of non-adherence; (3) review the consequences of non-adherence in terms of patient outcomes.

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A Vendor-Agnostic Platform: Making Centralized Surveillance A Reality

March 4th, 2015

The widespread availability of personal computers and the Internet helped revolutionize the clinical trial industry by creating an eclinical ecosystem of electronic data capture tools that eliminated the need for paper forms and facilitated the expansion of clinical trials to sites around the world. While these tools brought many advantages, they also created new challenges by creating silos of information and limiting visibility into the clinical trial process. Several solutions have been proposed to integrate the fragmented data and obtain operational intelligence about study status in real time. The most promising is a cloud-based solution that overlays a client’s existing data capture systems and extracts data without requiring updates or changes to the underlying software. This webinar will discuss the Cloud-Computing approach, and highlight a case study of a successful implementation that enabled real-time insights across the customer's eClinical ecosystem.

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Effective Use of eCOAs in Respiratory Trials: Case Studies and Practical Considerations

February 26th, 2015

Clinical Outcome Assessments (COA) have become increasingly important in the evaluation of new medications for chronic respiratory conditions. This webinar will discuss how clinical trial sponsors are benefiting from the use of electronic COAs in trials of asthma, COPD, and other respiratory conditions and will review current trends for optimizing clinical trial processes including the collection of spirometry values and patient reported outcomes (PRO) data on one integrated device.

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Is the Thorough QT Study Still Required? – Recent Regulatory Developments in Cardiac Safety

January 28th, 2015

It has been nearly 10 years since the approval of the ICH E14 guidance, which described the requirements for a Thorough QT/QTc study (TQT) to assess a new drug’s liability for producing lethal ventricular arrhythmias. Since 2005, a TQT study has been required for all small molecule drugs which can safely be tested in healthy volunteers. Concerns have been raised, however, about the high cost of the TQT study and about the inhibitory effect that this guidance has had on drug development. Recently, two proposals for replacing the TQT have been discussed – one to replace the TQT with a series of preclinical studies, and the second to replace the TQT with intense ECG and PK data collected during Phase I ascending dose studies. A meeting was held on Dec 11-12, 2014 by the Cardiac Safety Research Consortium and the FDA to discuss these two proposals and to present the results of a prospective trial to test the feasibility of using Phase I ascending dose data to replace the TQT. The webinar will discuss the results of this new study, progress towards developing alternative pathways to the standard TQT, and the changing regulatory environment for cardiac safety in drug development.

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