Determining the Suitability of Registries for Embedding Clinical Trials in the United States: A Project of the Clinical Trials Transformation Initiative

• Published in: Therapeutic innovation & regulatory science 2021-01, Vol.55 (1), p.6-18
• Main Authors: Mikita, J. Stephen, Mitchel, Jules, Gatto, Nicolle M., Laschinger, John, Tcheng, James E., Zeitler, Emily P., Swern, Arlene S., Flick, E. Dawn, Dowd, Christopher, Lystig, Theodore, Calvert, Sara B.
• Format: Article
• Language: English
• Subjects: Clinical decision making; Clinical trials; Data Collection; Decision making; Decision trees; Drug Safety and Pharmacovigilance; Embedding; Humans; Medicine; Original Research; Pharmacotherapy; Pharmacy; Registries; Reproducibility of Results; United States
• ISSN: 2168-4790; 2168-4804
• DOI: 10.1007/s43441-020-00185-5

Background Patient registries are organized systems that use observational methods to collect uniform data on specified outcomes in a population defined by a particular disease, condition, or exposure. Data collected in registries often coincide with data that could support clinical trials. Integrating clinical trials within registries to create registry-embedded clinical trials offers opportunities to reduce duplicative data collection, identify and recruit patients more efficiently, decrease time to database lock, accelerate time to regulatory decision-making, and reduce clinical trial costs. This article describes a project of the Clinical Trials Transformation Initiative (CTTI) intended to help clinical trials researchers determine when a registry could potentially serve as the platform for the conduct of a clinical trial. Methods Through a review of registry-embedded clinical trials and commentaries, semi-structured interviews with experts, and a multi-stakeholder expert meeting, the project team addressed how to identify and describe essential registry characteristics, practices, and processes required to for conducting embedded clinical trials intended for regulatory submissions in the United States. Results Recommendations, suggested practices, and decision trees that facilitate the assessment of whether a registry is suitable for embedding clinical trials were developed, as well as considerations for the design of new registries. Essential registry characteristics include relevancy, robustness, reliability, and assurance of patient protections. Conclusions The project identifies a clear role for registries in creating a sustainable and reusable infrastructure to conduct clinical trials. Adoption of these recommendations will facilitate the ability to perform high-quality and efficient prospective registry-based clinical trials.