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TransCelerate BioPharma, FDA/NIH collaborate on aligned common protocol template

Wednesday, May 3, 2017

TransCelerate BioPharma announced the availability of an enhanced technology-enabled Common Protocol Template (CPT). This update to the CPT is in alignment with the common protocol template launched by the FDA and the NIH. This collaborative effort reinforces the need for harmonized protocol formats and content that aligns objectives and endpoints with accepted data standards.

Dalvir Gill, Ph.D., CEO of TransCelerate BioPharma, noted, “This milestone represents TransCelerate’s continued focus on innovation, process efficiency and partnership, as well as our goal of simplifying clinical trials. This aligned CPT effort could not have come to fruition without the strong collaboration of the FDA and NIH. We will continue to work with our partners including the Clinical Data Interchange Standards Consortium to develop an automated solution that facilitates the use of data standards required for protocol endpoints.”

Since 2010, the number of new studies registered in Clinical Trials.gov has increased by approximately 20,000 per year. This includes studies sponsored by pharmaceutical companies, academic centers, contract research organizations and members of the NIH, among others. Despite this diversity in clinical research, the protocols that must be developed rely on the same regulatory infrastructure for design, review and implementation. This long-felt unmet need led TransCelerate, in conjunction with the FDA and NIH, to recognize a significant opportunity for improved quality and a reduction in complexity through a closely aligned, common protocol effort.

“The FDA and NIH see protocol harmonization as an essential component to the accelerated delivery of medicines to patients,” said Janet Woodcock, M.D., director of the FDA’s Center of Drug Evaluation and Research. “Having aligned templates will help enable health authorities to receive consistent, high-quality protocols, enable timely review and ultimately ensure trial participant safety.”

“Recent data indicates that 66% of protocols are amended and one-out-of-ten of these protocols are related to human error. The CPT Initiative has worked to decrease protocol related issues frequently reported by trial sponsors, investigator sites, regulators and patients by creating common content that can be used by any stakeholder such as a health authority or Investigational Review Board,” said Rob DiCicco, PharmD, Clinical Innovation & Digital Platforms for GlaxoSmithKline and TransCelerate CPT Initiative Leader.

Dr. DiCicco said, “We are hopeful that the intentional connectivity between objectives and endpoints, as well as future connectivity with study procedures, will enable reviewers and other key stakeholders to promptly identify disconnects and unnecessary complexity that often accompany today’s industry sponsored protocol.”

The template created by the FDA and NIH was developed with single-center NIH sponsored trials in mind, while the TransCelerate CPT includes additional text to support global, multicenter trials and supports re-use of protocol level information for other requirements of clinical trials, such as statistical analysis plans and clinical trials registry posting.

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