Ten notable “trial flops of 2018” included five Alzheimer’s trials and five in other conditions, and the majority failed due to lack of efficacy. The developers of these drug candidates were big pharma companies –Merck & Co., Roche, Johnson & Johnson, Celgene, Takeda Pharmaceutical, Boehringer Ingelheim – as well as smaller companies including Incyte Corporation, eTV Therapeutics, Sarepta Therapeutics, and Alkermes. (BioSpace)
Clinical trials underestimate adverse events associated with immunotherapies
www.specialtypharmacytimes.com
An analysis of adverse events (AEs) associated with immune checkpoint inhibitors based on insurance claims suggests that the frequencies of immune-related AEs may be higher than reported in trials that led to the FDA approvals for immunotherapies. The researchers suggest that real world data could refine our expectations for outcomes beyond what is reported in clinical trials. (Specialty Pharma Times)
Facebook and Twitter talk could compromise clinical trial integrity
Patients are online, and they are talking about clinical trials. Social media interactions are allowing patients to make more informed choices about clinical trials, but the flow of information also has the potential to sway trial results when patients share study details. According to Craig Lipset of Pfizer, “It’s only a matter of time before Facebook jeopardizes the scientific integrity of a study.” (nature.com)
FDA developing guidance on patient engagement in medical device trials
FDA’s Patient Engagement Advisory Committee (PEAC) is seeking public input to inform its draft guidance on developing patient-oriented medical device trials. This call for feedback is part of PEAC’s charter in 2017 to include patients in the device regulation process. The forthcoming FDA guidance intends to demystify patient engagement in the clinical trial process. (MEDTECHDIVE)
FDA will issue policies targeting “quality control” activities in clinical trials
The U.S. Food and Drug Administration (FDA) will soon be issuing specific policies aimed at reducing the burdens associated with the conduct of clinical trials. These policies could target “quality control” activities in clinical trials, which, according to FDA Commissioner Scott Gottlieb, aren’t necessary in a digital age and add unnecessary workload and cost. (acrp.net)
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