The availability of large-scale human genomic data sets raises questions regarding their proper collection, use and governance. The Presidential Commission for the Study of Bioethical Issues is currently focusing on these issues and is seeking input from medical professionals , scientists, ethicists, patient…

Amateur clinical researcher Melanie Swan recently published a paper in the journal Personalized Medicine, proposing a model for “extending crowdsourced studies beyond small-group experimentation to large-scale intervention-based research studies that are professionally run and scientifically rigorous, in effect creating a…

In March 2012, FDA issued a finalized version of its guidance titled, “Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications”. Although the explicit scope of this guidance is limited, the benefit and risk considerations are broadly…

According to RDP Clinical Outsourcing, pharmaceutical companies and trial sites need to think more strategically about recruitment. Almost 80% of clinical trials are delayed, with 20% being delayed for 6 months or more. There are a number of reasons why…

FDA recently held a public webinar to discuss its draft guidance recommending targeted safety data collection in certain drug trials. The presentation and slides are now available on FDA’s website. According to FDA, selective safety data collection may: Improve the quality…