Left unexamined, a slew of unintended consequences centered on the shifting roles and responsibilities among sites, sponsors, and principal investigators (PIs) could derail some of the promise of decentralized clinical trials (DCTs), members of a roundtable discussion convened by the Association of Clinical Research Professionals (ACRP) said yesterday (May 11).
Among core issues, panelists said, are the implied and formally regulated responsibilities of PIs for overseeing the work of vendors or other third parties in the conduct of hybrid (onsite/offsite) or full DCTs, such as those conducting home healthcare visits and/or administering medication to a patient as part of a remote visit.
“Who accepts the responsibility?” asked David Morin, MD, FACP, CPI, FACRP, a seasoned PI as director of research at Holston Medical Group and 2022 Chair of the ACRP Association Board of Trustees (ABoT), noting the topic had not yet been adequately addressed by regulators. “We need to address these issues [and see their potential] impact on patient safety and data integrity,” he said.
“PIs can’t be left out of this discussion,” Morin added. “PIs need to trust the process” so they will have a “comfort level” about work they sign-off on, he noted.
“How will PIs be reassured and covered if a problem occurs” under their supervision during a DCT trial, wondered Anne Blanchard, CCRA, CPM, FACRP, an ABoT member and clinical research executive consultant based in Latin America. “These are open questions we need to raise. We need to respect the role of physicians and PIs in clinical trials,” added Blanchard. “Patients are only protected if a physician or PI takes full control of the trial.”
Further, sites want to be certain anyone they send out into the field as part of a DCT has proper training, stressed Christina Brennan, MD, MBA, CCRC, vice president of clinical research at Northwell Health and a member of the ABoT. “We need to understand what it will take for sites to be ready for DCTs,” she added.
For full DCT and hybrid options to work most effectively, sites must feel comfortable with the quality of the team handling remote patient visits and can’t feel “dictated to” by sponsors, Brennan said.
It’s vital for there to be a “transparency of credentials for the PI to see” when considering who to add to their team and whose work to feel comfortable with, said R’Kes Starling, RPh, MBA, CEO and founder of Reveles Clinical Services and a member of the ABoT. “Training and visibility are a big part of” building that trust, he added.
Brennan called for a more “patient-centric and site-centric” approach, emphasizing choice when it comes to how to best leverage DCTs.
“It shouldn’t be all or nothing,” agreed Mohammed Ali, senior vice president and general manager for decentralized clinical care at Medable and a member of the ABoT. Instead, patients and the clinical trial ecosystem will benefit most from selecting “components” of DCTs, he noted.
Ali sees the current situation as rife with opportunity to harness the best of DCTs. Among other action items, he called for more alignment in clinical trial operations and development of a “playbook” focusing on driving quality and other core principles in DCTs.
Overall, the promise of DCTs is clear (as noted in a recent ACRP white paper), and many sites appear eager and willing to step up to accelerate clinical research, but are they able and ready to do so? Sites, contract research organizations, and sponsors must collaborate on real-world strategies for adopting DCTs—strategies that take into account the realities of those responsible and accountable for managing clinical trials.
“The prevailing wisdom about DCTs is that technology will lead the way,” said ACRP Executive Director Susan Landis. “But there are other critical elements that need to be defined in more and better detail than they have been so far. Diving into the lesser discussed topics like training, transparency, and data integrity will round out the discussion, raise the issue of risk management, and allow trust to be built.”
The topic of how sites and PIs are adopting DCTs as well as the documentation of barriers to implementing DCTs will be addressed at the next ACRP Think Tank in the fall.
Author: Michael Causey