Dr. Lyric Jorgenson has co-authored this blog with Dr. Joni Rutter (r). Dr. Rutter is the Director of the National Center for Advancing Translational Sciences (NCATS) within NIH.
Have you ever tried to put together a jigsaw puzzle without looking at the completed picture they include in the box? How about trying to build a model airplane without consulting the step-by-step instructions? Being able to see the end from the beginning helps guide the direction of what you are trying to build. Without it, you are simply looking at individual pieces that might obscure the clarity of the big picture. Just as these tools help guide assembly, case studies help guide understanding and implementation in clinical research. This might be one of the reasons why so many people within the biomedical research community rely on (and request the development of) case studies as an educational resource to better understand policy matters.
When OSP recently announced the ENGAGE initiative, we immediately recognized an opportunity to provide practical, real-world examples of the many effective tools, strategies, and best practices of clinical research engagement being used by NIH’s Institutes and Centers. To be the most useful, a case study must present relatable problems, tangible results, and generalizable conclusions. Without these elements, the risk of your case study being seen as a “one-off” experience is magnified. Fortunately, NIH has a wide body of experience to draw from to create case studies that would be useful to our research community.
NIH has added a section to the ENGAGE website (PartnersinResearch.nih.gov) dedicated to presenting these tools, strategies, and best practices in case study form. These case studies are aimed at three primary audiences:
- Patients, Caregivers, and Advocacy Groups: These stakeholders can benefit from understanding how to effectively collaborate with researchers in the development and oversight of clinical studies. The case studies provide practical examples of successful patient engagement, illustrating how active involvement can influence research outcomes and ensure that studies address the real-world needs and concerns of patients and their families.
- Community Members: Individuals can benefit from insights into the methods and importance of participating in clinical research. The case studies demonstrate how community involvement can enhance the relevance and cultural sensitivity of research, ensuring that the findings are more broadly applicable and beneficial to diverse populations. They also aim to empower community members to become active contributors to the research process. and
- Researchers and Research Teams: Members of these communities can benefit by learning how to integrate engagement strategies into their work. The case studies provide evidence-based practices and models for fostering collaborative decision-making, equitable engagement, and sustainable capacity building within research programs. By learning from these examples, researchers can improve the design and implementation of their studies, ultimately enhancing the impact and ethical integrity of their work.
The case studies also cover five broad areas associated with clinical research engagement, including:
- Collaborative Decision-Making
- Equitable Engagement
- Methods of Engagement
- Sustainable Engagement & Capacity Building
- Return of Research Value
The case studies cover a broad range of NIH resources, programs, and strategies. For example, some of the case studies include materials to help patients and patient advocacy groups partner with scientists in the treatment development process, some describe models for integrating patients and community members into the oversight of research programs, and others describe strategies for creating institutional capacity to ensure that meaningful engagement is sustainable over time.
We encourage you to take a look! Right now, there are 14 case studies available for use which can be accessed at https://partnersinresearch.nih.gov/case-studies/. As the ENGAGE initiative continues, we plan to add more case studies that reflect the knowledge base we are building. NIH, through the ENGAGE Working Group, is working hard to ensure that all public voices are not only heard but meaningfully incorporated into NIH-supported clinical research. We hope you find these case studies useful as a first step in achieving that goal.
