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…

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…

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…

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…