The National Institutes of Health (NIH) on April 26 published a Request for Information (RFI) inviting comments on “the appropriate inclusion of pediatric and older populations in research studies involving human subjects.” Responses are due June 30. The RFI provides an opportunity for the scientific community and the public to express their views, while feedback was gathered from subject matter experts at an accompanying workshop, held June 1-2 on the NIH campus.
NIH seeks input on a number of topics proceeding from including vulnerable populations, like children and adults age 65 and older, in clinical research. For example, how best to design studies to ensure all appropriate ages are included; ethical challenges when including—and ethical justification for excluding—these populations; legal and administrative barriers to inclusion; and approaches for standardizing reporting of enrollment data and results.
In its response, FASEB does not directly address the specific points of interest raised by NIH because, in our opinion, they are too complex to address thoughtfully and completely within the time provided. Rather, FASEB recommend three general steps NIH should take to promote age group inclusion.
First, FASEB says that enrollment in clinical research should operate under the assumption that all ages be included baring scientific justification for excluding one or more age groups. Moreover, all ages and groups should be enrolled in sufficient numbers to support statistical inference; that is, saying that children are represented in a study because there are two five year-olds is not acceptable.
Second, FASEB supports the idea of reporting all participants’ ages at the time of enrollment, as opposed to categorizing them into age groups. This would increase transparency and ease comparisons across multiple studies.
Finally, FASEB recommends that NIH explicitly state in funding opportunity announcements (FOAs) for clinical trials that age inclusion will be one of the criteria considered by reviewers when arriving at an application’s score. NIH has announced that beginning in September, it will only accept clinical trial applications submitted in response to specific FOAs. FASEB’s recommendation underscores that NIH takes age inclusion seriously and that investigators proposing clinical studies are expected to as well.