Trial Better: The ERT Blog

50% OF ALL NDAs SUPPORTED SINCE 2014

TRIAL BETTER

See what we’re up to – and what we have to say – in today’s dynamic market.

Methods Matter: Accelerating Oncology Clinical Trials

In this series, learn how to make changes to your oncology development program that improve data quality and accelerate the development of new cancer treatments.

The Importance of Patient and Caregiver eCOA Training in Clinical Trials

This blog reviews the critical role advanced and customized training plays in improving data quality in clinical trials where patient-reported outcome (PRO) and observer reported outcome (ObsRO) assessments support key efficacy endpoints.

Racing for a COVID-19 Vaccine: Ensuring eCOA Data Quality When Time is of Essence

Learn how, by using an electronic solution to capture critical patient data, sponsors can meet their accelerated trial timelines while still maintaining data integrity during vaccine clinical trials.

Developing an Imaging Charter for Clinical Trial Imaging

Here, we review the contents of an imaging charter, which clinical trial sponsors are encouraged to develop and adhere to in order to optimize the quality of imaging data obtained in clinical trials.

The Value of Standardized Imaging Protocols in Oncology Clinical Trials

This blog focuses on imaging evaluations (e.g. CT/MRI) used as an outcome endpoint to determine efficacy when assessing novel cancer therapies.

Should I use a Subspecialist for Clinical Trial Imaging Reads?

Here we review the rationale for using subspecialist readers to interpret medical images when used in support of clinical study endpoints.

BYOD 2.0: A More Inclusive Approach to eCOA in Clinical Trials

Learn how evolving technology is enabling remote research to expand so that previously excluded patient populations can now participate in clinical trials.

Statistical Approaches to Blinded Reader Monitoring in Clinical Trials

Take quiz: blinded reader monitoring in imaging clinical trials

The Importance of Protocol Compliance in Imaging Studies

In this blog, we present the practices imaging providers should follow to ensure compliance with relevant regulations when imaging is used to capture safety or efficacy data in clinical trials.

When is the Use of eCOA Recommended in Clinical Trials?

Here we review why the use of eCOA is recommended and how sponsors can benefit from leveraging electronic data capture in oncology, phase I/II and large-scale clinical trials.

Artificial Intelligence and Machine Learning: Part 1 – Definitions, Similarities and Differences

Here we review the distinct meanings and discernible differences between artificial intelligence, machine learning and deep learning and why, although related to each other, they are not interchangeable.

When it’s Critical to Use eCOA in Clinical Trials

In this first of a series of when to use eCOA in clinical trials, we present examples of study types, endpoints and patient populations that deem the use of eCOA critical to the trial’s success.

Centralized versus Site-based Imaging Reads in Clinical Trials

Analyze the differences between centralized and local site-based reads, including their respective impact and value.

The Importance of Data Integration in Clinical Trials

Today’s common practice of using disparate systems to collect study data makes it difficult for researchers to manage trial performance and uncover valuable insights about the treatments they are developing. Learn how today’s trial oversight technology overcomes these challenges and improves trial efficiencies.

Which Imaging Standard is Right for my Clinical Trial?

Understand the two types of imaging process standards (medical practice and trial-specific) and learn how to determine which is appropriate for your clinical trial.

Patient-Reported Outcome Data in Oncology Trials – Part 2: Clinical Benefit & Patient Preference

Here we present current research on clinical benefits that have been demonstrated through the use of electronic PRO data capture – including improved survival – and review new findings on preference for electronic PRO data capture among patients with cancer.

Top 5 Considerations for Implementing ABPM in Clinical Trials

In this second part of a series, we outline the factors sponsors need to consider when implementing Ambulatory Blood Pressure Monitoring during clinical trials to ensure the collection of valid and useful data for regulatory submissions.

Assessing Neuro-Oncology Disease in Pediatric Clinical Trials

Learn how the use of standardized imaging protocols with appropriate radiological and clinical response assessments (based on tumor characteristics) can improve the robustness of clinical trial data and the chances to obtain positive results in pediatric neuro-oncology trials.

How to Assess for Suicidal Ideation & Behavior in Clinical Trials: Part 2

Learn the different approaches to assessing Suicidal Ideation and Behavior (SIB) during clinical trials and how to ensure you’re meeting regulatory requirements and keeping patients safe.

Patient-Reported Outcome (PRO) Data in Oncology Trials – Part 1: Regulations

In this first of a 2-part series on the importance of PRO data in oncology drug development, we review the latest regulatory guidances recommending the use of PROs in oncology trials.

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