Drugs

5 Themes in Innovative Trial Approach Meeting

The Duke-Margolis Institute for Health Policy has released its summary of a 3/19-3/20 public meeting held with FDA on enhancing the adoption of innovative clinical trial approaches. The workshop discussion aimed to better understand shared opportunities for communication and cooperation to enhance the development and adoption of innovative approaches in clinical trials to promote timely and reliable evidence generation on drug safety and efficacy, the summary says. It discusses the five themes that arose at the meeting:

promoting change management to address risk aversion with innovative clinical trial approaches;
expanding inclusion of the patient community;
thinking and working globally to harmonize on innovation;
closing the gap between clinical care and clinical research; and
a roadmap for wider adoption of clinical trial innovation.

“Looking to the future,” the summary concludes, “clinical trial innovation is sparking continued interest in drug development and requires sustained communication and collaboration that will transcend single groups of parties. This meeting showcased the need for buy-in from different groups across the clinical development spectrum to create sustainable innovation in trial design, conduct, and analysis. Further forums, both public and private, can facilitate the continued development of a roadmap to promote innovation across the clinical trial enterprise. The future roadmap for clinical trial innovation will involve sustained communication and collaboration across parties. It is critical to build on FDA’s existing pilots and programs to move from proof-of-concept to implementation at scale, and thoughtfully further integrate these efforts across therapeutic areas and drug development programs.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome