Updated common protocol templates align clinical trial objectives, endpoints

TransCelerate BioPharma’s enhanced, technology-enabled Common Protocol Template (CPT) was created in alignment with the NIH/FDA-developed template, which was finalized​ early last week.

The FDA/NIH template is intended for NIH-funded studies, while the TransCelerate CPT​ includes additional text to support global, multicenter trials and re-use of protocol level information for other clinical trial requirements.

Both templates aim to increase efficiencies in clinical trial protocol development.

To learn more about the updated CPT, Outsourcing-Pharma.com talked with Dalvir Gill, CEO of TransCelerate.

How has the CPT evolved to become the current version? ​

The TransCelerate team first established key principles needed in a Common Protocol Template: structure must be streamlined and consistent, it must enable common wording relevant for all phases, and finally, it must enable endpoints that map to objectives and support the use of CDISC therapeutic area standards.

We leveraged the experience of our member companies, taking the best components from each of their existing templates. We gathered input from key stakeholders such as sites, IRBs, CROs, regulators, and CDISC. Over the past year, we collaborated with the NIH-FDA Protocol Template team to harmonize structure of the two templates.

What are some of the most important components of the template?​

The most important aspect of the Common Protocol Template is the established level 1 and 2 heading structure which will allow sites and regulator reviewers to easily find information. The adjustments to the structure in the current release were reached in collaboration with the NIH-FDA Protocol Template team as we aligned both templates.

Other important aspects include alignment of objectives and endpoints; establishing common endpoints aligned to the CDISC Therapeutic Area standards, and common language when we used consistently will speed the time to first draft and reduce human errors.

How will having a standardized template help advance research?​

Having a Common Protocol Template will ease protocol interpretation and review by sites, IRBs, and regulators. Protocols have become increasingly complex and difficult to navigate, with sponsors providing protocols in their own structure. Sites spend time deconstructing and interpreting protocols when that time would be better spent with patients.

Every clinical trial needs an approved protocol and since 2010, the number of new studies registered in Clinicaltrials.gov has increased by ~20,000 per year – that’s 20,000 clinical protocols, with no standardization for initial review.

Our collaboration with NIH-FDA to align the structures of CPT and their newly released protocol template will take harmonization and information sharing even further. Following a harmonized template will also enable review and even comparisons of studies and by regulators.

How does it facilitate the use of data standards required for protocol endpoints?​

The CPT therapeutic area libraries establish common objectives and endpoints based on the CDISC Therapeutic Area User Guides. Utilizing the CDISC Therapeutic Area Standards is one step toward an end to end use of standards.

The latest release of the CPT includes therapeutic area libraries in Alzheimer’s Disease, Asthma, Diabetes, and Thorough QT (TQT). More libraries will be developed during 2017.

What are the next steps for the CPT Initiative?​

In the short term, we hope to increase the usability and value of the Common Protocol Template by incorporating feedback from stakeholders and expanding the library selections to include additional Therapeutic Areas.

We are also investigating transformative changes in automation, content reuse, and traceability that may be enabled from a harmonized protocol in order to reduce the time to study start up.