Raising the bar on data and biosample sharing from AD/ADRD clinical trials
Over the last seven years, NIA’s funding for Alzheimer’s disease and related dementias (AD/ADRD) research has steadily increased, allowing continued expansion and diversification of our drug development portfolio and translational infrastructure programs to help advance future therapeutics. As discussed in our prior post, the translational infrastructure is built around open-science and open-source principles. These programs are designed to more rapidly deliver data resources, knowledge, and research tools that may lead to more candidate drugs meeting primary clinical endpoints, and ultimately, true precision medicine approaches to AD/ADRD therapy development.
Sharing data — at both the summary and participant levels — and biosamples from clinical trials is critical for helping us understand factors that impact the success or failure of therapeutic agents, including differences in how AD/ADRD unfolds in individual participants and how different people respond to treatment. This helps avoid duplicating trials unnecessarily and increases the speed and efficiency of the clinical trial enterprise.
Bringing Open Science to Clinical Trials
In 2015, the Institute of Medicine published the first set of guidelines outlining responsible clinical trial data sharing for the entire biomedical community. At the same time, a coalition of stakeholders including FDA, NIA, the Alzheimer’s Association, clinical trialists, and trial sponsors developed the Collaboration for Alzheimer’s Prevention (CAP) set of data and sample sharing principles for Alzheimer’s prevention trials that was published in 2016. The key CAP principles include making screening data and biosamples available within 12 months of completing enrollment and making placebo and treatment arm data and samples available after regulatory approval or within 18 months after the completion or early termination of a trial.
We began raising the bar for data and resource sharing from AD/ADRD clinical trials with the Accelerating Medicines Partnership-Alzheimer's Disease (AMP-AD) Biomarkers Project, which added tau imaging to two AD/ADRD prevention trials. A provision of AMP-AD was that, similar to CAP, screening data and biosamples from the Alzheimer’s prevention trials would be made broadly available.
In 2019, the A4 Study, one of the AMP-AD trials, became the very first trial to make its screening data and biosamples available. The data from more than 3,000 screened individuals can be accessed via the University of Southern California’s Laboratory of Neuro Imaging. The trial is currently ongoing with anticipated completion in 2022.
Starting in 2018, we have codified these data sharing expectations across the NIA AD/ADRD clinical trial funding initiatives (see PAR-18-877/878 and PAR-20-309). Specifically, registration trials are expected to share resources according to the CAP principles. For earlier stage trials, resources must be shared upon acceptance of primary publication or within nine months of trial completion, whichever comes first. In addition, implementing best practices for sharing trials data, methods, and biosamples is at the core of the Alzheimer’s Clinical Trials Consortium, NIA’s next-generation clinical trials infrastructure.
Plan ahead for sharing in your applications
So what does this mean for you if you are planning to submit a clinical trial application? First and foremost, be sure to plan for data and biosample sharing at the outset of developing an application. This includes appropriately budgeting for these efforts and communicating with relevant NIA program officers for additional guidance on this critically important aspect of your application. If you have questions, please reach out to the contacts listed on the relevant FOA, contact your NIA program officer, or leave a comment below!