Common Protocol Template—Streamlining Protocol Implementation

Study protocols are required for every clinical trial. Approximately 20,000 are submitted and posted to www.clinicaltrials.gov every year¹—each one different. The format and core content can vary from sponsor to sponsor, costing the US Food and Drug Administration (FDA) time and resources to interpret, review, and ultimately, approve each uniquely complex protocol. This process, as it stands, slows down progress for new drug development. Clearly, there is a need to accelerate the pace at which protocols are approved so that new clinical studies can be initiated. In a world where technology continues to offer a platform for efficiency and accuracy, the development of the Common Protocol Template (CPT) is a welcome addition to the medical field. Common Protocol Templates can lead to faster review time, simplified trial startup, and prompt execution of clinical trials. Although the use of a CPT is not required for all new clinical trials, it is only a matter of time before its use becomes commonplace in drug development.

In late 2015, TransCelerate BioPharma got together with 18 biopharma companies to find a way to address this unmet need, and they ultimately devised a CPT.² The National Institutes of Health (NIH)/FDA soon followed suit with a CPT of their own, which launched in March 2016. In May 2017, TransCelerate collaborated with the NIH/FDA to synchronize the 2 templates, including the Level 1 and Level 2 heading structures and their corresponding terminology and intended section content.²

In response to this collaboration, Janet Woodcock, MD, Director of the Center for Drug Evaluation and Research at the FDA, made the following statement: “The FDA and NIH see protocol harmonization as an essential component to the accelerated delivery of medicines to patients. Having aligned templates will help enable health authorities to receive consistent, high-quality protocols, enable timely review and ultimately ensure trial participant safety.”³

The TransCelerate CPT also offers protocol-defined objectives, endpoints, and data standards by leveraging existing clinical data standards and therapy area user guides with the Clinical Data Interchange Standards Consortium (CDISC). Therapy-specific libraries allow users to directly import information into the protocol template. This allows for consistent terminology throughout the protocol and the data that will later be published, and it facilitates future comparisons across trials in a specific therapeutic area.¹

Rob DiCicco, PharmD, Vice President of Clinical Innovation and Digital Platforms for GlaxoSmithKline and TransCelerate CPT Initiative Leader, commented, “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.”³

So, where can you find these templates? The CPT for the NIH/FDA, located at https://osp.od.nih.gov/clinical-research/clinical-trials/, is primarily aimed at single-center, investigator-led, NIH-sponsored, phase 2 and 3 studies.¹ The TransCelerate Biopharma CPT, found at http://www.transceleratebiopharmainc.com/assets/common-protocol-template/, is intended for multicenter, global, phase 1-4 studies.² These templates, both of which can be submitted to the FDA, offer user-friendly documents, with guided instructions and examples, and facilitate development of high-quality protocols.

As more companies begin to use CPTs, it is anticipated that the consistency between sponsor protocols and the overall study timelines will improve due to easier review and faster approval times. Increased efficiency for trial participants and ease of data interpretation are future benefits that may hasten the availability of new medicines.

Holly C. Cappelli, PhD, combines her scientific expertise in biomedical science and physiology with 1 year of global medical communications agency experience and has provided content development support for live educational events, medical communications, and publications. Connect with Holly on LinkedIn.

References

1. DiCicco, R. (June 15, 2017). Cross-Stakeholder Collaboration: Advancing Research Through Common Protocol Templates. Retrieved from https://www.clinicalleader.com/doc/cross-stakeholder-collaboration-advancing-research-through-common-protocol-templates-0001.
2. Alsumidaie, M. (June 30, 2017). TransCelerate Establishes Technology Common Protocol Template and Collaborates with FDA/NIH. Retrieved from http://www.appliedclinicaltrialsonline.com/transcelerate-establishes-technology-common-protocol-template-and-collaborates-fdanih.
3. Business Wire. (May 2, 2017). TransCelerate BioPharma and FDA/NIH Collaborate on Aligned Common Protocol Template. Retrieved from http://www.businesswire.com/news/home/20170502005627/en/TransCelerate-BioPharma-FDANIH-Collaborate-Aligned-Common-Protocol.