Drugs

Comments on Incorporating Patient Perspectives in Trials

Pharmaceutical Research and Manufacturers of America (PhRMA) says it believes that increasing patients’ awareness of and access to clinical trials are critical factors in making drug development innovation possible. Responding to an FDA 3/18 workshop on enhancing the incorporation of patient perspectives on clinical trials, the industry group says it also believes that a science-driven approach that considers the importance of enhancing patient awareness and identifying methods to increase participant access is an important consideration when designing a drug development program.

The comment letter says the workshop discussion “underscores the need for FDA to support the use of patient input by offering actionable standards and a robust framework for collection and systematic incorporation of patient input for the purpose of informing regulatory guidance and decision-making. PhRMA also believes FDA should continue to work toward developing documents and communications that reflect the principles and recognized best practices for health literacy and for reaching audiences with varying degrees of health literacy.”

In its comment, the Leukemia and Lymphoma Society says its clinical trial nurse navigators know from first-hand experience that patients desire more information about clinical trials to make informed treatment decisions. The society says it thus supports FDA efforts to improve public and patient engagement in clinical trials. “We believe that this work will ensure that trials are relevant and clinically meaningful and will improve study recruitment and retention rates,” it says. “Increasingly complex and expensive clinical trials place a significant burden on clinical research professionals and often impede the willingness of volunteers to be screened for and remain in a study through completion.”

The Lupus Foundation of America says it believes that “improving the clinical trials experience and participation is an integral part of improving overall therapy development for lupus.” The foundation urges FDA to consider ways to foster flexibility on trial screening and enrollment protocols to allow participation in trials of those who may not meet all diagnostic or classification criteria. It also recommends having a greater number of geographically dispersed trial sites.

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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