TransCelerate BioPharma and FDA/NIH Collaborate on Aligned Common Protocol Template

Reinforces Need for Harmonized Protocol Formats and Supports Use of Data Standards for Required Trial Objectives and Endpoints

PHILADELPHIA--()--TransCelerate BioPharma Inc. today 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 US Food and Drug Administration (FDA) and National Institutes of Health (NIH) accessible here. This collaborative effort reinforces the need for harmonized protocol formats and content that aligns objectives and endpoints with accepted data standards.

Dalvir Gill, PhD, CEO of TransCelerate BioPharma, Inc., 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 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,” states 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 percent 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 goes on to note, “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.

About the TransCelerate CPT Initiative

The TransCelerate CPT Initiative aims to reduce complexity in clinical trial protocols by making implementation and reporting less difficult for sponsors, sites, regulators and, most importantly, patients. The creation of the CPT enables industry trial sponsors, working with other stakeholders, to standardize the format of trial protocols and to develop standards for required protocol endpoints, in alignment with the TransCelerate Clinical Data Standards Initiative. Last year, TransCelerate launched a technology enabled edition of its CPT, which enabled automated re-use of information and point and click population of selected template sections, among other features. The CPT templates, libraries containing common and suggested text pertinent to certain studies and implementation toolkit materials are accessible to the public through the TransCelerate website.

The TransCelerate CPT Initiative, coupled with the work done by the FDA/NIH has the potential to minimize confusion for stakeholders and allow benefits such as site simplified start up and execution, as well as faster review time by health authorities. Other potential benefits include:

  • Investigator Sites: improved access to streamlined information within protocols; increased consistency between sponsor protocols and reduced need for additional workflow documentation
  • Institutional Review Boards: enhanced review of data which can allow for easier submission review and potential for a faster approval
  • Health Authorities: streamlined protocols should be easier to review, and allow for an increased ease of data interpretation and improved ability to compare clinical trial protocols. The TransCelerate Template introduces data standards in its endpoint sections and the use of controlled terminology permits automated reuse and introduces the concept of traceability
  • Patients: improved communication with investigator sites due to increased consistency between protocols
  • Clinical Trial Sponsors: increased operational efficiencies in the creation of clinical trial protocols, automation of downstream processes and improved reuse of content, improved conduct of the study and quality of data collected

About TransCelerate BioPharma, Inc.

TransCelerate BioPharma Inc. is a non-profit organization dedicated to improving the health of people around the world by simplifying and accelerating the research and development (R&D) of innovative new therapies. The organizations' mission is to collaborate across the global biopharmaceutical R&D community to identify, prioritize, design and facilitate implementation of solutions designed to drive the efficient, effective and high quality delivery of new medicines. TransCelerate evolved from conversations at various forums for executive R&D leadership to discuss current issues facing the industry, and examine solutions for addressing common challenges. The founding member companies are AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, the Roche Group, and Sanofi. Additional members that have joined since the inception of TransCelerate include Allergan, Inc., Amgen, Astellas Pharma Inc., EMD Serono, Inc. (a subsidiary of Merck KGaA, Darmstadt, Germany), Merck & Co., Inc., Novo Nordisk, Shionogi & Co., Ltd. and UCB.

Membership in TransCelerate is open to pharmaceutical and biotechnology companies with Research & Development operations. Executive offices are located in Philadelphia, PA. For more information, please visit

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Bliss Integrated Communication
Vicky Aguiar, 212-584-5470


Bliss Integrated Communication
Vicky Aguiar, 212-584-5470