Differences Between Drug and Medical Device Trials: CSRs

While drugs and medical devices are both essential in modern medical care, there are times when standard clinical development processes seem to treat medical devices as an afterthought. For example, medical writers for a CRO conducting studies of both drugs and devices must learn to interpret a drug-centric guidance document to author an appropriate Clinical… Read more »

Thinking of Women’s Healthcare Needs on International Women’s Day

As a CRO focused on clinical development of products to improve women’s healthcare, Health Decisions sees International Women’s Day as an occasion to redouble our commitment to enabling drug, diagnostics and medical device companies to bring new women’s health products to market as rapidly and efficiently as possible. For Health Decisions, the scope of women’s… Read more »

Addressing High Failure Rates in Drug Development

FDA has published an excellent report on 22 instances in which phase 2 and phase 3 trials had divergent results. Appendix A of the report provides justifications for essential elements of modern clinical trials, including a control group, randomization and blinding. In addition, Appendix A highlights risks of techniques for improving efficiency in early development,… Read more »

2017 – Time for a Bold R&D Initiative in Women’s Health

Despite NIH and FDA women’s health policy initiatives previously described in this blog, the list of novel drugs approved by FDA in 2016 includes only one product for a woman-specific health indication. FDA granted accelerated approval in December 2016 for rucaparib (Rubraca™), a Clovis Oncology PARP inhibitor for ovarian cancer. Rubraca is indicated for patients… Read more »

Settling on a Framework for LDT Regulation: Update

Update: The FDA post-election statement on delaying implementation of the agency’s draft guidance on LDTs affirms the status quo – for now. The delay allays the concerns of some stakeholders about potential effects of greater FDA involvement in LDT regulation, such as slowing innovation in diagnostics and patient access to the most advanced diagnostics and,… Read more »

ASRM-NICHD Workshop Focuses on Expanding Access to ART

The 2016 Scientific Congress of the American Society for Reproductive Medicine (ASRM) is in full swing in Salt Lake City. Among the events of greatest interest to the Health Decisions contingent at the congress is “Advancing Science and Practice to Improve Access in Reproductive Care,” a workshop jointly sponsored by ASRM and the Eunice Kennedy… Read more »