Health Decisions completed a metastatic breast cancer study a full year ahead of schedule and saved the sponsor approximately $2 million in direct costs through agile enrollment and a tiered global enrollment strategy, demonstrating the ability to achieve rapid enrollment and reduced cost in oncology clinical trials.
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So far healthdec_rljyp3 has created 33 blog entries.
For an oncology biologic program, we worked with the client to combine PoC and dosing studies into a single study based on ability to continuously track outcomes. One of the other key features was continuously projecting where the study would end up, based on data to date. The design provided for stopping the study [...]
In observing International Clinical Trials Day for 2017 on May 19, Health Decisions wishes to thank all those who participate in clinical trials. Health Decisions especially thanks patients enrolled in our current trials but we want to thank trial participants everywhere for making clinical development possible. While sponsors and CROs like Health Decisions make every [...]
For National Women's Health Week last year, this blog focused on the need for progress in a variety of areas in which women have unmet medical needs. Last year's post mentioned the need for progress in noninvasive diagnostics and therapeutics for osteoporosis, female sexual dysfunction, endometriosis, bacterial vaginosis and uterine fibroids. This year we want [...]
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 [...]
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 [...]
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, [...]
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 [...]
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, [...]
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 [...]