The Health Decisions team at DIA 2018 left with the impression that the biopharma industry values relationships with patient advocacy groups but use of such groups in study planning and protocol development remains the exception rather than the rule. Health Decisions’ Chief Medical Officer Andrea Lukes, MD, MHSc, FACOG, chaired a DIA forum entitled “From Patients and Advocacy Groups to Operations and Beyond: Obtaining and Incorporating Input from Stakeholders in Protocol Design.” Clint Dart, Health Decisions’ Senior Director, Biostatistics and Programming, participated along with Michelle Witkop, DNP, Head of Research, National Hemophilia Foundation. Discussions following the forum showed that most biopharma companies in attendance are still exploring the possibility of involving advocacy groups rather than actively collaborating.

“Health Decisions is hoping to make a positive impact on women’s health by encouraging sponsors and investigators to consider working with advocacy groups,” Dr. Lukes said. “I know from direct experience that working with advocacy groups as a Principal Investigator benefits trials and I am convinced that many sponsors would benefit from greater involvement with advocacy groups.”

“One person resolved to start working with advocacy groups now,” Mr. Dart said. “That’s a positive sign but it will take time to build the relationship and determine how the organizations can work together to optimize the design and enrollment of clinical trials. FDA is planning to issue a guidance on patient-focused development and mentions patient advocacy groups in a document about that. That may lead to greater industry involvement with advocacy groups.” (FDA’s Plan for Issuance of Patient‐Focused Drug Development Guidance.)

“Patient advocates’ voices were amplified even more at this year’s DIA than previous years,” said Rachel Hardin, Health Decisions’ Head of Business Development. “This was true whether it was the panel that Health Decisions co-led on incorporating the patient perspective in clinical research, or the various advocacy groups that came by our booth to learn more about what Health Decisions is doing to advance clinical research for women in a variety of indications. These are powerful allies in our quest to improve healthcare outcomes for women worldwide. We are looking forward to forging new partnerships in areas like breast cancer and gynecologic oncology, autoimmune disease and other key therapeutic areas to drive greater patient centricity in all that we do.”