Turning Points: The ERT Blog

50% OF ALL NDAs SUPPORTED SINCE 2014

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).

Capture High Quality Respiratory Data: Don’t Let Spirometers Get in the Way

Avoid spirometry equipment that gets in the way and ensures patients perform the required maneuvers effectively, so you get valid and reliable respiratory data to support every clinical trial, every time.

Wearables in Clinical Trials: Where we’re Heading

Wearables are improving the clinical trial experience for patients and satisfying the need to collect data for real-world use studies. In this interview, ERT’s Karin Beckstrom provides insight into how wearables are being used in clinical trials today, and what the future has in store.

Detecting Myocarditis in Oncology Trials with Imaging

Advanced imaging techniques can be used to assess for myocarditis (which has been reported with immune checkpoint inhibitors) before initiating cancer therapy, as well as for monitoring during and after treatment.

How to Reduce Clinical Trial Risk: Shift to Active Risk Management

Here we review how trial sponsors can achieve the highest quality data, study performance improvements, and significant savings throughout clinical trials.

Customizing Clinical Trial Imaging to Support a Claim: A Case Study

When it comes to clinical trial imaging, a one-size-fits-all approach just doesn’t work. Creative problem-solving and scientific expertise are critical to meeting each sponsor’s unique needs. Here we review how Medtronic captured the data they needed to demonstrate product superiority by relying on ERT’s advanced imaging technology and scientific expertise.

3 Strategies to Capture ~ 100% Acceptable Respiratory Data in Clinical Trials

Collecting ATS/ERS-acceptable data is a fundamental goal for any pharmaceutical company involved in respiratory clinical trials. Here we present the three strategies clinical trial sponsors can adopt to ensure their data meets regulatory standards and helps them achieve their clinical objectives.

Keeping Clinical Trial Patients Safe: Why you can’t rely on Automated ECG Machine Measurements

Here we explain why relying entirely on ECG machine QTcF measurements for clinical trial decisions may have critical consequences for trial integrity as well as for patient safety, based on a recently conducted comparison study.

Monitoring Cardiotoxicity in Clinical Trials through Imaging: Practical Considerations

Learn the potential treatment-related cardiovascular issues trial sponsors should consider when creating drug development plans and how the appropriate imaging endpoints can help to define CV risks in clinical development.

Using Cardiac Imaging to Identify Cardiovascular Treatment-related Effects during Oncology Clinical Trials

The importance of evaluating cardiotoxicity during the clinical development of therapeutic agents cannot be understated. In this first of a 2-part series, we review several imaging methods that can support cardiac safety endpoints in oncology clinical trials and how imaging core labs can assist trial sponsors in evaluating these advanced techniques for incorporation into study protocols.

Transforming Clinical Trials through the Power of AI

By making clinical trials more intelligent, optimizing end-to-end processes and delivering greater insight for smarter decision making, Artificial Intelligence (AI) has the power to transform the clinical trials industry. Learn how AI, machine learning and deep learning techniques can drive clinical trial efficiencies and help pharma bring new drugs and therapies to the market faster.

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