There is a heightened energy in the research world. We know that broadening representation in clinical study participation is paramount to the future of research and medicine.

Decades of data serve as evidence of the disproportionate statistics that exist regarding participants from underserved communities in clinical studies.1,2 With this, the moral and scientific imperatives to make changes that include greater awareness, access and reduced burden are undeniable.

Regulatory bodies, sponsors, patient engagement groups are all in discussion and collaboration around community partnerships,3 patient involvement, and reducing study burden.

Finally, leaders in research are taking the time to include these key stakeholders in conversations that influence the design and conduct of studies. By taking their time, key stakeholders create space to speed up recruitment of the right people and for the acquisition of quality data that boasts integrity through inclusivity.

These are all the right steps to take. Frankly, it’s about time. However, have we completely considered this new change and approach? What do tactics such as community-based sites and partnerships mean? What is the impact on the community, healthcare system, study sites and sponsors?

The old adage is that change takes time, but change also takes work. These new changes bring about curiosity regarding the who and the how. Who is taking the brunt of the extra work? A potential answer could be those who are closest to the participants and the data: research study site staff and monitors. But do the resources exist to support them?

All around the world, healthcare systems and hospital staff are struggling to contend with residual effects of COVID-19,4 mental health and anxiety, impacts of war, impending recessions, an aging and retiring population of healthcare workers, burn out and simply being tired of it all.5 How do we then layer action plans, training and added responsibilities to individuals who are already stretched, regardless of its importance? What steps will be integrated in these plans to address impacts of high staff turnover? This includes the exodus of veteran researchers, seeking retirement, and taking with them valuable knowledge and compliant study conduct.

Patient engagement plans are needed. Without them we will continue to chase change instead of making it, but plans will only work if there are those who enact and govern them. Responsibility will fall to many at every level, including study site staff. So, as we look to make things better for patients and families, let’s keep in mind those who will work to make it all happen.

We’ve been listening, reflecting, thinking and we are curious. We have ideas, but don’t have all the answers. If, like us, you have been considering these questions, then let’s discuss.

  1. Ejiogu N et al. Recruitment and retention strategies for minority or poor clinical research participants: lessons from the Healthy Aging in Neighborhoods of Diversity across the Life Span study. Gerontologist 2011;51(Suppl 1):S33–45.
  2. Fisher JA, Kalbaugh CA. Challenging assumptions about minority participation in US clinical research. Am J Public Health 2011;101:2217–22.
  3. Maxwell AE et al. Exploring the effects of longstanding academic-community partnerships on study outcomes: A case study. Prev Med Rep 2017;8:101–7.
  4. Koontalay A et al. Healthcare workers’ burdens during the COVID-19 pandemic: a qualitative systematic review. J Multidiscip Healthc 2021;14:3015–25.
  5. Gwede CK et al. Burnout in clinical research coordinators in the United States. Oncol Nurs Forum 2005;32(6):1123–30.