News from Wednesday, January 26, 2022
Articles
Value Assessment And Decision Making In The Face Of Uncertainty
(1/26, Jeroen P. Jansen, Mark Linthicum and Richard H. Chapman, Health Affairs Blog) comments “...Although there are significant limitations to using non-randomized real-world data to estimate relative treatment effects, this strategy can, if used sensibly, supplement trial evidence to help estimate subgroup effects. To better inform value assessments, we should incorporate these data into comparative effectiveness analyses more frequently despite the more labor-intensive and less straightforward analytical requirements of such a synthesis.” Full
The Certainty Of Uncertainty In Health Technology Assessment
(1/26, Joshua T. Cohen, Natalia Olchanski, Daniel A. Ollendorf and Peter J. Neumann, Health Affairs Blog) comments “...HTA bodies should promote consideration of multiple possibilities for qualitative assumptions...HTA bodies should also publish assessment model source code—the model’s human readable instructions...Finally, HTA documents should comprehensively report uncertainty’s influence on cost-effectiveness results and value-based prices.” Full
Concerns Mount over Limited Evidence for Accelerated Approvals
(1/26, Jill Wechsler, PharmExec) comments “...While sponsors often experience difficulties enrolling patients in clinical trials once a therapy is available on the market, weak FDA penalties for delay, as well as incentives for a firm to provide an approved therapy for as long as possible, contribute to perennial delays in submitting follow-on results. The need for better systems to generate reliable information on medical product safety and effectiveness was cited as a top priority by Robert Califf at his Senate confirmation hearing in December 2021, and he is expected to tap his expertise on providing timely and valid clinical research data in addressing these issues. The discussion is slated to involve appropriate use of real-world data to support postapproval studies, as well as requirements for sponsors to design and launch confirmatory trials at the time of application approval...” Full
Syracuse University, MGH Institute of Health Professions Receive Support for Innovative Research Ethics Training
(1/26, Syracuse University News) reports “A project led by Katherine McDonald, associate dean of research and professor of public health in Syracuse University’s Falk College, and Ariel Schwartz, assistant professor of occupational therapy at MGH Institute of Health Professions, aims to help individuals with developmental disabilities affecting cognition contribute fully to community-engaged research. The project is supported by a funding award through the Eugene Washington PCORI Engagement Awards program, an initiative of the Patient-Centered Outcomes Research Institute.” Full
Press Releases
Selective Laser Therapy Recommended to Treat Glaucoma and Ocular Hypertension
(1/26, NICE Press Release) “People newly diagnosed with glaucoma and ocular hypertension (OHT) should initially be offered selective laser therapy (SLT) treatment rather than eye drops, according to an updated NICE guideline published today.” Full