Features

New Collaboration Aims to Use Advanced Data Analysis to Speed Trials

February 4, 2019

A Michigan CRO is teaming with MIT’s Computer Science and Artificial Intelligence Laboratory and the University of Maryland’s Center for Transitional Medicine (CTM) to create what organizers are calling “a supergroup” that will help speed drugs through the clinical trials pipeline.

FDA Back to Work; Gottlieb Announces New Clinical Trial Plan

January 28, 2019

On the first day back to work after the record-breaking government shutdown, FDA Commissioner Scott Gottlieb announced new plans to explore the use of digital technologies that bring trials to patients and increase access to real-world evidence.

Centralized Monitoring in Practice — Lessons Learned from Early Implementers

January 21, 2019

A survey conducted recently by Metrics Champion Consortium shows most of the responding sponsors — 90 percent — indicate they are implementing ICH’s new centralized monitoring approach to risk management, but only about a third of that number say they have fully integrated it into their trials operations. See Figure 1.

Almost all (93 percent) cited detecting risks to subjects and data integrity as the primary reason to conduct centralized monitoring, and three quarters of respondents said it was both a good predictor of the need for individual site visits and detector of potential fraud and/or misconduct among trial staff.

“Onsite monitors are not able to see how their sites compare to others in the same study — whether their performance, data trends, etc., are outliers compared to other sites,” says MCC Executive Director Linda Sullivan. A particular benefit of centralized monitoring is the ability to identify whether data is being fabricated, Sullivan says, something very difficult for an onsite monitor to do. See Figure 2.

FDA Commissioner Warns of Shutdown’s Impact on Clinical Trials

January 14, 2019

As the partial government shutdown entered a record-setting fourth week, FDA Commissioner Scott Gottlieb said it was no longer “business as usual” at the agency — calling the shutdown “one of the most significant operational challenges in FDA’s recent history.”

Establishing Indemnification in a Clinical Trial Agreement Requires Precise Language

January 14, 2019

Negotiating a clinical trial agreement (CTA) can be a maze of confusion, filled with difficult-to-understand legalese and contractual traps seemingly around every corner. An accidental omission, an unintended commitment, or even just the wrong choice of words can lead to misunderstandings and an agreement that fails to do what you want it to.