Medical research at the clinical trial stage is critical for evaluating new therapies to combat disease and promote health. But this final phase of research can be extremely slow and difficult, sometimes taking years to move a potential treatment from the laboratory to patients. Enrolling participants into clinical trials is increasingly challenging, and the traditional trial process—although long-respected as the gold standard—requires rethinking.
The National Institutes of Health (NIH), the nation’s premier medical research agency, is exploring ways to increase the efficiency of clinical trials to shorten the time it takes for a potential therapy to reach patients while maintaining quality and patient safety. This effort is focused on identifying and reducing barriers to clinical research, and NIH has engaged HCM Strategists to help. HCM has brought patients and members of the health advocacy community together to ensure that their experiences and views inform the NIH as priority areas are identified.
HCM hosted a town hall meeting to open a dialogue. More than 80 patient organizations met with NIH to discuss such challenges as trust, oversight, and community involvement. Participants raised issues and suggested areas for potential reform. By engaging the patient advocacy community, HCM helped NIH build a foundation of support and identified contributors to the process of developing recommendations that will improve clinical trials.
As patient advocacy organizations have begun to directly invest and participate in clinical research, many of these organizations have developed an internal expertise in clinical research. In addition, many have specific experiences related to barriers to clinical research and have been experimenting with innovative approaches to address these barriers. HCM identified these organizations, conducted in depth interviews with their scientific staff and compiled a compendium detailing these approaches as well as providing analysis to highlight common themes and issues.
This information assisted NIH in selecting barriers on which to focus for developing potential solutions. HCM then surveyed patient advocacy organizations with experience in any of the priority issues to obtain detailed information on their experiences and views to further inform the NIH as the project moves forward. Throughout the project, HCM has been focused on ensuring that the patient’s perspective and experiences help to inform the shape and scope of the project as well as potential solutions.