The lack of consistency between clinical trials conducted for any given medical condition is a continual point of complaint in the research community. It is a hard problem to solve, as illustrated by the long history of such complaints and little consequent difference in the state of trial design. Still, one can make efforts. The best way forward is perhaps to propose a detailed standard and then advocate for it. For the longevity field, the authors of this paper take a first step in that direction with a set of recommendations for data collection in studies of therapies to treat aging.
Biomarkers of aging have the potential to transform geroscience clinical trials because of their broad applications in stratifying participants, prioritizing interventions, and monitoring responses to geroprotectors. As longevity biotechnology companies (LBCs) continue to plan and launch innovative clinical trials, standard practices in collecting data and applying biomarkers of aging will allow the field to support parallel and ongoing validation and benchmarking efforts for aging biomarkers. Moreover, defining standard best practices will ensure future reuse of valuable clinical data. Here, we propose recommendations for such collections. We believe that wide adoption of these recommendations will allow LBCs to produce and leverage the highest quality data from their clinical trials, while also benefiting the geroscience field more broadly with minimal additional effort.
In an ideal world, studies would collect as many samples as possible in order to establish arepository of biospecimens and data for research. Although a comprehensive repository is useful, it may not be feasible for collection in all trial protocols. As such, we propose a prioritization framework for assessment of what is most important to collect, based on three main pillars: 1) feasibility, 2) representation, and 3) range of use. Feasibility refers to the effort required for collection in trials; representation refers to how representative the sample is of the overall aging process; and range of use relates to the number of different analyses that can be conducted with the sample. Based on these criteria, we recommend that, at minimum, blood, which provides a snapshot of biological features, and wearable data, providing continuous information on functional features, should be collected and stored.
In addition to the importance of collecting biological and wearable data, it is essential to collect corresponding participant information. Associated data should include detailed demographic information, medical history, family medical history, and health outcome data, where possible. Irrespective of the indication under assessment in the trial, a broad range of health outcomes corresponding to age-related disease (e.g. cardiovascular diseases, dementia, and cancers) should be monitored, with monitored outcomes determined by balancing additional trial complexity and data richness, and also considering the length of the study.
Informed patient consent is an essential part of all clinical trial protocols, ensuring the subjects understand the purpose of a trial, what data will be collected and processed, and their responsibilities and rights as a study participant, including the ability to cease participation at any time. Beyond the minimum consent requirements for clinical trials, it is becoming increasingly important to obtain explicit consent for future activities associated with biomarker research and analysis of biobanked samples to reduce the need to re-engage trial participants for consent once the trial has been completed.
Link: https://doi.org/10.1038/s41514-025-00313-1
View the full article at FightAging
