“You are the engine of clinical trials,” Dr. Pamela Tenaerts, MD, MBA, executive director of the Clinical Trials Transformation Initiative (CTTI), told attendees at the kickoff session of ACRP 2018 today (April 28).
“You are truly making a difference,” said Jim Kremidas, executive director of ACRP and part of a panel at the “Signature Series Session: Meet the Changemakers: Driving Clinical Research Quality Through Collaborative Leadership.” Kremidas added, “you should be proud.”
At the same time, panelists said, it’s time to raise the bar when it comes to clinical trial implementation. “We see the same problems consistently,” Kremidas said. He cited three:
- Just 10% of studies are completed on time.
- The U.S. Food and Drug Administration (FDA) cites the same compliance deficiencies each year.
- A dearth of industry-wide collaboration.
“We haven’t united holistically” to share best practices and better synchronize the various aspects of clinical trial work, Kremidas said. “Patients are waiting,” he added.
Change isn’t easy, panelists unanimously agreed. Trial practitioners of all stripes “need to understand why [others] do things they way them do them,” Tenaerts said. As an industry, we need to get away from the mentality of “the other person needs to change,” she added.
The prescription? Meaningful communications and collaboration, panelists emphasized. However, those conversations won’t happen without a push, said Andy Lee, senior vice president and head of clinical trial operations for Merck Inc. and treasurer of TransCelerate, the latter being a collaboration among big pharma sponsors to share effective tools and tactics.
It’s no easy task to bring together professionals across the clinical trial spectrum. “Definitions become very important,” Lee said.
“We talk past each other frequently,” Kremidas said.
Tenaerts reported that CTTI is doing a good job at reaching out to principal investigators, but needs to improve its outreach to clinical research coordinators.
Lack of communication and understanding is also making clinical trials more difficult for patients – and that’s going to drive them away at a time when the demand for clinical trials continues to increase, panelists said.
“We impose a lot of burdens on people who participate in clinical trials,” said Doug Peddicord, PhD, executive director of the Association of Clinical Research Organizations (ACRO). He cited studies that found the average participant must travel 50 miles to engage in a trial. ACRO is the “voice of CROs” at the FDA, Capitol Hill, and with regulators around the world. From Peddicord’s perspective, communication is improving between sponsors and CROs, though there’s more to be done.
Lee shared an encouraging development. More and more sponsors are sharing placebo information, which can help a later trial avoid repeating that aspect of data collection. “Why put people through [possibly receiving a placebo]” if it isn’t necessary, Lee said. He also lauded ACRP’s Good Clinical Practice training as a way to help industry come together and begin to standardize practices.
“Your voice needs to be part of the conversation,” Kremidas told attendees. “Share your thoughts about what’s working and what’s not.”
“It’s very important for the people here to use ACRP as a unified voice” to represent their interests in the clinical trial process, added Peddicord.
Author: Michael Causey