Turning Points: The ERT Blog

50% OF ALL NDAs SUPPORTED SINCE 2014

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.

Assessing Suicidal Ideation & Behavior (SIB) Risk in Clinical Trials: Part 1

Learn when and how to monitor suicidal ideation and behavior (SIB) to ensure patient safety and adhere to regulatory guidance in clinical development.

What You Need to Know about the Latest ABPM FDA Guidance

Here we review recent FDA guidance that advises sponsors on assessing a drug’s effect on blood pressure and how ABPM keeps patients safe during clinical trials.

Blinded Reader Training for Clinical Trial Imaging

This blog provides insights regarding the importance of rater training in clinical trial imaging.

Get the Most out of eCOA: Today and Tomorrow

Learn about current eCOA trends and what we can expect from this valuable clinical research tool in the future in this interview with ERT’s David Elario.

Clinical Trial Imaging: A Focus on Reader Agreement

Learn the many factors that influence overall reader performance / reader discordance and how they can affect results when imaging is used to evaluate clinical trial endpoints.

The Impact of Expanding Reader Pools in Clinical Trial Imaging

In this blog, we discuss the option of selecting a fixed versus rolling reader pool for the most common reader paradigm deployed in clinical trial imaging.

Best Practices for Effective Data Governance in Clinical Trials: Part 2

Learn why effective data governance is so critical in the clinical development and how you can improve clinical trial efficiencies by following these best practices.

The Need for Effective Data Governance in Clinical Trials: Part 1

Learn about the importance of effective data governance in clinical research in the first part of this 2-part series.

Clinical Trial Imaging: How to Manage Blinded Independent Central Reads and Independent Safety Committees

Here we review situations where regulators, based on elevated concerns for safety, request to have safety assessments collected by clinical trial imaging confirmed independently via BICR and/or a Data Safety Monitoring Committees (DSMC).

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