TY - JOUR
T1 - Matching enrolled trial participants to disease demographics
T2 - Using IRB submissions to identify opportunities for researcher training
AU - Eckstrom, Elizabeth
AU - Zauflik, Meredith
AU - De Lima, Bryanna
N1 - Publisher Copyright:
© The Author(s), 2023. Published by Cambridge University Press on behalf of The Association for Clinical and Translational Science.
PY - 2023/5/8
Y1 - 2023/5/8
N2 - Background: Many diseases are highly prevalent in older adults, yet older adults are often underrepresented in corresponding trials. Our objectives were to (1) determine alignment between Institutional Review Board (IRB) protocol age ranges and enrollment demographics to disease demographics pre- and post-implementation of the 2019 National Institutes of Health (NIH) Lifespan Policy and (2) raise awareness about inclusive recruitment to principal investigators (PIs). Methods: This was a pre-post study. We reviewed investigator-initiated studies meeting eligibility criteria at Oregon Health & Science University from 2017 to 2018 to determine baseline alignment. Alignment was defined by the level of matching between protocol/enrollment age and disease demographics: 2 points for full match, 1 point for partial match, and 0 points for mismatch. After the NIH policy implementation, we reviewed new studies for alignment. When a mismatch was determined, we contacted PIs (either at initial IRB protocol submission or during ongoing recruitment) to raise awareness and provide strategies to expand inclusion of older adults in their trials. Results: Studies that matched IRB protocol ages to disease demographics significantly improved from 78% pre-implementation to 91.2% post-implementation. Similarly, study enrollment ages matching disease demographics increased by 13.4% following the implementation (74.5%–87.9%). Out of 18 post-implementation mismatched studies, 7 PIs accepted a meeting and 3 subsequently changed their protocol age ranges. Conclusion: This study highlights strategies that translational institutes and academic institutions could use to identify research studies whose participants do not align with disease demographics, offering opportunities for researcher awareness and training to enhance inclusion.
AB - Background: Many diseases are highly prevalent in older adults, yet older adults are often underrepresented in corresponding trials. Our objectives were to (1) determine alignment between Institutional Review Board (IRB) protocol age ranges and enrollment demographics to disease demographics pre- and post-implementation of the 2019 National Institutes of Health (NIH) Lifespan Policy and (2) raise awareness about inclusive recruitment to principal investigators (PIs). Methods: This was a pre-post study. We reviewed investigator-initiated studies meeting eligibility criteria at Oregon Health & Science University from 2017 to 2018 to determine baseline alignment. Alignment was defined by the level of matching between protocol/enrollment age and disease demographics: 2 points for full match, 1 point for partial match, and 0 points for mismatch. After the NIH policy implementation, we reviewed new studies for alignment. When a mismatch was determined, we contacted PIs (either at initial IRB protocol submission or during ongoing recruitment) to raise awareness and provide strategies to expand inclusion of older adults in their trials. Results: Studies that matched IRB protocol ages to disease demographics significantly improved from 78% pre-implementation to 91.2% post-implementation. Similarly, study enrollment ages matching disease demographics increased by 13.4% following the implementation (74.5%–87.9%). Out of 18 post-implementation mismatched studies, 7 PIs accepted a meeting and 3 subsequently changed their protocol age ranges. Conclusion: This study highlights strategies that translational institutes and academic institutions could use to identify research studies whose participants do not align with disease demographics, offering opportunities for researcher awareness and training to enhance inclusion.
KW - Disease demographics
KW - inclusion in research
KW - lifespan
KW - older adults
KW - trial recruitment
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U2 - 10.1017/cts.2023.539
DO - 10.1017/cts.2023.539
M3 - Article
AN - SCOPUS:85160831961
SN - 2059-8661
VL - 7
JO - Journal of Clinical and Translational Science
JF - Journal of Clinical and Translational Science
IS - 1
M1 - e114
ER -