“As an industry, we have to find more efficient ways to get exciting new, safe, and efficacious therapies into the hands of physicians,” says Jamie Macdonald, chief executive officer at PAREXEL International and a recognized clinical trial thought leader.
It’s not about any lack of innovation, he stresses. Instead, an increasingly challenging environment with more focus on personalized medications and narrowing patient populations are presenting real obstacles to conducting quality clinical research, Macdonald says.
When in doubt, think about the patient, he advises. “We have to put that perspective [into action]—‘Are we doing the right things for patients?’ [and] ‘Are we moving development ahead as efficiently and effectively as we can?’” Patients must be at the core of everything we do, he stresses. He’s also bullish on collaborative designs of clinical trials tapping into patient experience, as well as leveraging new data and real-world evidence.
Recently, the U.S. Food and Drug Administration (FDA) reopened the comment period for the document entitled “Framework for FDA’s Real-World Evidence Program,” which appeared in the Federal Register on December 7, 2018. The agency is taking this action to allow interested persons additional time to submit comments, which are now due April 16.
The Future of Clinical Research: Where We Are Heading and What It Means to You
Get a multi-stakeholder view into the future of clinical research by attending this ‘Signature Series’ session at ACRP 2019 in April. Gain an understanding of what the future might look like for clinical trials, how our panelists are preparing for that future, and how you can prepare yourself.
- David Burrow, Director, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
- Jamie Macdonald , Chief Executive Officer, Parexel International
- Dalvir Gill, PhD, Chief Executive Officer, TransCelerate BioPharma, Inc.
- John P. Neal Chief Executive Officer, PCRS Network, LLC
“What we hear is that there is a burden now with systems and technology and data,” Macdonald says. “Are we over-engineering a lot of the work we do and losing sight of the patient?”
For Macdonald, the ACRP 2019 conference coming up in April in Nashville, Tenn. is a perfect venue for this important conversation. “ACRP represents a broad group of stakeholders—[one that is] particularly focused in and around the site and patient activity,” he notes. Working together, Macdonald hopes “we get to a point where therapies come through that development process more efficiently, and we can make those ‘stop-go’ decisions as quickly as possible.”
Author: Michael Causey