The NIH-FDA Joint Leadership Council and TransCelerate BioPharma released updated common protocol templates (CPT) last week to accelerate clinical development. An Outsourcing-Pharma.com article and interview with TransCelerate CEO, Dalvir Gill, details some of the key additions to the new templates and how they will help advance research.
First and foremost, both the FDA/NIH and TransCelerate BioPharma templates aim to increase efficiencies in clinical trial protocol development. The FDA/NIH template is intended for NIH-funded studies. Global, multi-center trials requirements are covered by the Transcelerate CPT. During the interview, Gill described the key principles needed in a Common Protocol Document. “Structure must be streamlined and consistent, it must enable common wording relevant for all phases, and… it must enable endpoints that map to objectives and support the use of [Clinical Data Interchange Standards Consortium] CDISC therapeutic area standards,” Gill explained. These requirements acted as the foundation on which Gill and his team built the new common protocol template.
Aligning objectives to endpoints
The CPT includes new elements that align objectives to endpoints. Most importantly, the newly established level 1 and 2 heading structure allows sites and regulator reviewers to easily find information. These structural changes appear in both the Transcelerate and NIH-FDA protocol templates. Additionally, “establishing common endpoints aligned to CDISC Therapeutic Area standards and common language when used consistently will speed the time to first draft and reduce human errors,” Gill stated.
The existence of a Common Protocol Template will ease protocol interpretation and review by sites, IRBs, and regulators. Protocols have increased in complexity as the number of new studies registered in Clinicaltrials.gov steadily increases year-by-year. Sponsors currently provide protocols in their own structure and sites spend more time deconstructing and interpreting protocols. That time could be spent more effectively, Gill lamented, which justified the need for a structural alignment between protocols. “[The] collaboration with NIH-FDA to align structures of CPT and their newly released protocol template will take harmonization and information sharing even further… a harmonized template will also enable review and even comparisons of studies by regulators.”
Next steps for the CPT initiative could include changes in automation, content reuse, and traceability. Gill hopes that these next steps could further reduce the time to study startup. Pearl IRB provides expedited and full board ICF/protocol reviews. Our efficient, experienced team delivers superior IRB services that effectively balance the needs of human subjects, sponsors, and institutions. Contact us today to discuss your clinical research needs.