In 2019, and in response to several analyses showing inadequate inclusion of older adults in clinical trials, the US National Institutes of Health (NIH) expanded their “Inclusion of Children” policy to include older adults. This new policy, entitled “Inclusion Across the Lifespan”, means that all approved trials from 2019 onwards should include a plan describing how participants across the lifespan will be included, as well as the scientific or ethical rationale for excluding participants on the basis of age.
There is clear evidence showing that COVID19 hits older adults the hardest: people aged over 65 account for 30-40% of COVID19 cases, and over 80% of deaths. To evaluate whether this age group is included in COVID19 treatment and vaccine trials, Benjamin Helfand, Dr. Sharon Inouye and colleagues reviewed all such trials entered into the www.clinicaltrials.gov database of worldwide clinical trials, publishing their results in the JAMA Neurology journal.
They identified 847 COVID19 clinical trials, 195 of which included an age cut-off for exclusion. In addition, they identified 252 treatment clinical trials which did not have an age-based exclusion, but exclusions that were at high risk of affecting older adults, such as compliance concerns, specific comorbidities and requirements of technology. Looking at 18 vaccine clinical trials, 11 applied age cut-offs excluding older adults, and the remaining 7 had broader, nonspecific exclusions. Overall, the authors found that over 50% of older adults are likely to be excluded from COVID19 treatment trials, which may limit the ability of these trials to evaluate the efficacy, dosage and safety of treatments for older age groups. Concluding, they called for greater efforts to ensure COVID19 trials are fully inclusive.
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2771091
