CLINICAL TRIALS & RESEARCH
Our Work

Oversight and Implementation of Decentralized Clinical Trials

The MRCT Center is collaborating with Medable and other organizations to address the oversight and conduct of decentralized and hybrid clinical trials (collectively, DCTs), with a focus on planning and monitoring the trial appropriately. 

While almost every trial utilizes some elements of technology, DCTs are highly variable in terms of the elements of ‘decentralization’ deployed throughout the trial, from remote recruitment utilizing social media, electronic consent, remote visits through either virtual visits or local providers, and use of devices and software for data collection, among others.  There is also significant variability in IRB understanding of DCTs and, therefore, often prolonged delay in approval.

Working with a multi-stakeholder task force, the first initiative of this project addresses the ethical review of DCTs, focusing on how DCTs differ from traditional clinical trials. Next, specific recommendations for the roles and responsibilities of PIs (including PI oversight) and sponsors will be addressed.

OBJECTIVES

  • Provide guidance and tools for IRBs, sponsors, investigators and their study teams regarding ethical review and approval of DCTs
  • Consider the specific responsibilities of principal investigators, sub-investigators, study staff, sponsors, and vendors in DCTs
  • Develop resources for use by stakeholders involved in DCTs

KeY MILESTONES

project Leadership & sTAFF

  • Barbara Bierer, MD., Faculty Director, MRCT Center
  • Hayat Ahmed, MSc., Program Manager
  • Pam Tenaerts, MD., Chief Scientific Officer, Medable, Inc.
  • Leanne Madre, JD, MHA, Vice President of Evidence & Best Practices, Medable, Inc.
  • Andre Chiriac, MD., Vice President of Medical, Medable, Inc.

Project Resources