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Update: The FDA post-election statement on delaying implementation of the agency’s draft guidance on LDTs affirms the status quo – for now.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 »

Health Decisions to Exhibit and Present at DIA 2016

On the eve of the 2016 Drug Industry Association 52nd Annual Meeting in Philadephia June 26-30, the Health Decisions event team is looking forward to lively discussions of clinical development issues in booth #1143, a busy calendar of meetings with current and prospective clients and leading a forum on one of the hottest issues in… Read more »

Marking International Clinical Trials Day 2016

International Clinical Trials Day takes place each year on May 20, commemorating the day in 1747 on which James Lind started his controlled trial of scurvy treatments. Health Decisions marked the day internally by celebrating our own project managers, clinical trial leads, clinical research associates, in-house clinical research associates, clinical trial assistants, biostatisticians and other… Read more »