Let's talk about inclusion of all ages in research
On June 1-2, 2017, the NIH will convene a workshop, “Inclusion Across the Lifespan,” in Bethesda, MD. Its goals are to broaden our understanding of the effect of age-related eligibility restrictions on clinical studies and trials, and to identify barriers and facilitators to the inclusion of volunteers of all ages in research. At the workshop, investigators with expertise in conducting clinical studies with pediatric and older populations, ethics experts, and other stakeholders will focus on these questions.
Registration for the workshop is open, but seating may be limited. Thus, we provide the option of watching the plenary sessions of the workshop by videocast. We also invite you and the community of stakeholders to contribute views and ideas through a Request for Information (RFI), that will be published in the near future seeking input on this topic. Keep an eye out for the announcement in the NIH Guide. The RFI will be open until June 30, 2017, for online input.
More attention to inclusion
We’ve made tremendous progress in managing diseases through the development of new drugs and devices over the years that were tested in clinical trials. But children and older people are often excluded from these trials, and this limits the generalizability of study results to some age groups with a high burden of certain diseases and disorders. For example, the drugs and dosages used to treat leukemia in children are different from those needed to treat the disease in adults. Further, trial results about the effectiveness of medications for high blood pressure will likely be different in people who are 40 years old compared to people who are 70 years and older.
After an extensive analysis of more than 600 NIH-funded phase 3 clinical trials we found that the age distribution of people enrolled in clinical trials for diseases common in older adults was often younger than the actual age distribution of the diseases in the U.S. population. This, and other data, motivated the NIH Inclusion Governance Committee last year to begin planning for the workshop. The effort was further spurred by passage of the 21st Century Cures Act (P.L. 114-255), which became law on December 13, 2016, calling for a workshop on the inclusion of pediatric and older populations in clinical studies within 6 months of the signing of the law.
What will we talk about?
The workshop has multiple goals and will include presentations showing that people from both ends of the age spectrum may not be adequately included in trials.
Working groups have been organized to discuss specific topics related to challenges and opportunities for inclusion of participants from scientifically appropriate age groups. The considerations will include the intersection of age at the two ends of the age spectrum, along with sex/gender, and race/ethnicity. Thus the working groups are charged to deliberate regarding:
- Study population: Inclusion/exclusion criteria, age restrictions, and their impact on study populations of clinical trials and clinical studies
- Study designs and metrics
- Ethical challenges and the enrollment of vulnerable populations
- Data collection and reporting to support age-specific and subgroup analyses
We expect that the main workshop outcome will be a summary of the perceived and actual opportunities and barriers to recruitment of children and older adults into clinical studies. Other outcomes will focus on strategies to facilitate including a scientifically justified study population in clinical studies and trials, including those sponsored by NIH.
Won’t you please join this dialogue? We hope that you’ll respond to the RFI, or consider attending the workshop in person or through videocast. Any comments to this blog will be forwarded to the meeting organizers. We look forward to hearing from you.