New toolkit to standardize guidelines for streamlined IRB/Ethics review of DCT applications

Medable Inc., the leading technology provider for patient-centric clinical trials, and the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center) announce a comprehensive toolkit for Institutional Review Boards (IRBs)/Ethics Committees (ECs) to standardize decentralized clinical trial (DCT) ethics review. The first-of-its-kind toolkit provides a common framework, tools, and best practices for uniform ethical review and approval and provides a roadmap for the ethical conduct of DCTs. Ultimately, such standardization will simplify, streamline, and speed the IRB/EC process – a key step towards more efficient, patient-centered research execution.

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MRCT Center and Medable Launch Comprehensive IRB/EC Review Toolkit for DCTs (Graphic: Business Wire)

“The new DCT IRB/EC Review Toolkit will ease ethics reviews of decentralized trials by establishing commonality and removing some of the guesswork that has made DCT reviews cumbersome,” said Dr. Barbara Bierer, Professor of Medicine at Harvard Medical School and Faculty Director of the MRCT Center. “The guidelines also clarify what information sponsors and investigators should provide to IRBs on the front end to avoid unnecessary delays.”

The National Institutes of Health and other industry groups have repeatedly identified reducing IRB turnaround time as “essential” as delays prevent treatments from getting to patients and slow the improvement of public health outcomes. As DCTs offer potentially faster clinical study execution, disjointed and inconsistent ethics reviews could unintentionally slow the process.

“The rapid evolution of DCTs have led to ethics review challenges, including lack of familiarity with the varied and evolving technologies, DCT risks, benefits, and ethical issues,” explained Robert Romanchuk, who represented Advarra on the IRB/EC task force. “Additionally, IRB/ECs have different requirements and logistics for submission, review processes, and approval criteria which often leads to variability. It is heartening that other stakeholders have now joined with IRBs to understand their unique concerns with DCTs and have provided guidance and best practices for IRBs, sponsors, and researchers as we move forward in better harmony together.”

A task force consisting of Advarra, MRCT Center, Medable, Food and Drug Administration (FDA), Office for Human Research Protection (OHRP), ethics committees, sites, patients, and patient advocates collaborated for more than 18 months to create the new DCT IRB/EC Toolkit. It encompasses 13 guides (organized around three themes of people, data collection, and data oversight) – addressing each common element of a decentralized trial. These range from electronic consent (eConsent), electronic clinical/patient-reported outcomes assessment (eCOA/ePRO), wearable devices, remote telehealth visits, and more. See Figure One.

“Decentralized trials hold tremendous promise but to realize their full potential, we must systematically review every step of the startup process to ensure we are uniformly implementing a DCT startup framework," concluded Dr. Pamela Tenaerts, Chief Scientific Officer at Medable. "Together, we are working to remove potential hurdles to DCT adoption by harmonizing the ethical review, approval, and conduct of DCTs.”

Medable has deployed its software-as-a-service platform in more than 300 decentralized and hybrid clinical trials in 60 countries, serving more than one million patients and research participants globally. Medable’s customers have achieved impressive results with decentralized and hybrid trials – including 200 percent faster enrollment and 50 percent cost reductions. A 2022 financial modeling of DCTs using industry benchmark and Medable data and conducted by the Tufts Center for the Study of Drug Development shows that, on average, decentralized trials can achieve net financial benefits ranging from five to 13 times for Phase II and Phase III trials, due to reduced trial timelines and other factors.

Learn more at the Drug Information Association (DIA)’s Annual Meeting in Boston on Tuesday, June 27^th at the Innovation Theater – 12:30-1 pm EST. Medable’s Pam Tenaerts and the MRCT Center’s Barbara Bierer will also be available to take questions at booth #339. Email lbarbadora@bigvalley.co to schedule.

About MRCT Center

The Multi-Regional Clinical Trials Center is a research and policy center associated with two of the world’s most respected names in healthcare, academia, and research: Brigham and Women’s Hospital and Harvard University. The MRCT Center’s mission is to engage diverse stakeholders to define emerging issues in global clinical trials and to create and implement ethical, actionable, and practical solutions to improve the integrity, safety, and rigor of global clinical trials.

About Medable

Medable is on a mission to get effective therapies to patients faster by transforming clinical drug development with disruptive technologies. The company’s digital platform streamlines design, recruitment, retention, and data quality for decentralized trials, replacing siloed systems with integrated digital tools, data and interfaces to accelerate trial execution. Medable connects patients, sites, and clinical trial teams to improve patient access, experience, and outcomes. Medable’s software has been named a Leader in the industry by both Everest Group and IDC. Medable is a privately held, venture-backed company headquartered in Palo Alto, California.

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@MRCTCenter and @medableinc launch comprehensive IRB/EC toolkit for DCTs to standardize guidelines for streamlined application review #clinicaltrials #DCTs #clinicalresearch #healthcare