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Help us shape the conversation on diversity in research participation!

Jaron Lockett
Jaron LOCKETT,
Health Science Policy Analyst ,
Office of Planning, Analysis, and Evaluation (OPAE)
.

We well know that poverty compounds the effects of ethnic and racial minority status to create a tapestry of disadvantage. Aging sharpens these differences and brings its own negative stereotypes, even to those who have previously enjoyed relative advantage. Why, then, are older adults too often excluded from clinical trials? Why are minority groups and socioeconomically disadvantaged people underrepresented? Surely these groups are the most important targets for intervention if we are serious in our efforts to reduce these disadvantages?

Working toward a solution

NIH and NIA have long focused on how to include people of all ages and from all backgrounds—children, minorities, people with disabilities, and many more—in research. For example, as mandated by the 21st Century Cures Act, NIH held a workshop in 2017 that resulted in several publications, including two JAMA viewpoint articles: Improving Public Health Requires Inclusion of Underrepresented Populations in Research; and Inclusion Across the Lifespan: NIH Policy for Clinical Research. Following the JAMA articles, my colleagues and I published a study on the overwhelming evidence that increased inclusion of older adults is crucial.

More recently, in January 2019, NIH implemented its Inclusion Across the Lifespan policy. Additionally, a significant effort is underway at NIA to support recruitment and retention of diverse participants in Alzheimer’s and related dementias clinical trials.

A chance to shape the discussion

This year brings an exciting opportunity to evolve and grow this conversation. We are preparing now for an important sequel to the 2017 workshop. A trans-NIH initiative, Inclusion Across the Lifespan-II (IAL-II), will take place September 2-3, 2020, on the NIH campus.

We hope IAL-II can focus on the science of recruitment and retention of populations representative of diseases studied and share evidence-based strategies to accomplish this. There will be a primary focus on pediatric and older populations. However, woven throughout the workshop will be a focus on issues across the lifespan, such as sex/gender, race/ethnicity, disability, geography (rural/isolated populations), language, pregnancy and motherhood, people living with multiple or chronic health conditions, and others.

We need your input!

We need you to weigh in and help shape the discussion at the IAL-II workshop! The Inclusion Across the Lifespan II Request for Information (RFI) was published recently and will be open until February 15. We welcome perspectives and comments from all interested stakeholders, including the scientific community, patients, caregivers, advocacy organizations, and the public on the following topics:

  • Challenges and barriers to enrollment of individuals of all ages in clinical research studies
  • Challenges and barriers to collection and reporting of participant-level data, including age at enrollment
  • Implementation strategies that address potential ethical challenges when including individuals under 18 years of age, frail or cognitively impaired older adults, and other vulnerable populations in clinical trials or clinical studies
  • Strategies and special considerations for including other underrepresented populations in clinical study designs that were not specifically addressed in the first workshop
  • Development, implementation, and dissemination of scientifically appropriate and ethical inclusion and exclusion criteria for clinical trials or clinical studies
  • The effect of developmental/aging stages on responses to biomedical and behavioral interventions and strategies to tailor study planning and implementation to life stages
  • How to overcome barriers to inclusion in clinical studies related to comorbidities, impairments, and disabilities
  • Practice- or evidence-based strategies and necessary adaptations in recruitment/retention methods, modified safety monitoring, and how to use life stage-specific and patient-oriented outcomes in clinical trials or clinical studies
  • Opportunities for education and outreach to clinical researchers, community physicians, and their patients about the importance of participation in research
  • Strategies to disseminate and support the adoption of proven implementation techniques and strategies that overcome barriers and maximize the inclusion of a broad range of diverse participants
  • Any other issues or concerns that NIH should consider regarding the implementation of optimal study designs that ensure the inclusion of participants across a broad range of ages and underrepresented groups

As noted, this is a trans-NIH initiative. Thus, we ask that you share this blog with colleagues in pediatrics and other applicable disciplines. All responses must be submitted via email. We hope you can also mark your calendars now for the September workshop and plan to join us in our next steps toward broadening inclusion for all!