An updated protocol writing tool developed by NIH and TransCelerate aims to help the clinical trials industry write better protocols. While it won’t necessarily help the clarity of writing, it does lay out a template to help guide the work.

Currently, 2,400 active users are developing protocols with the help of NIH’s e-Protocol Writer, an online tool that walks teams of investigators through protocol development, making sure they apply scientific standards required by NIH and the FDA as well as standards of good clinical practice, such as ICH E6 and E8.

“We like to think of this as a sort of Turbo Tax for clinical trial protocols,” says NIH. 

Lyric Jorgenson, deputy director of NIH’s Office of Science Policy, shared with CenterWatch Weekly some insight on the value of the free online tool. 

“Investigators usually write protocols off lab history and other published data, but this can help them have something to start with and can easily conform to the registration reporting requirements of the NIH,” said Jorgenson. “We want to minimize the administrative burden on them as much as possible.”

Other companies offer electronic protocol-writing tools, but this is the only freeware version available. 

“We have been figuring out ways to harmonize with different agencies,” said Jorgenson. “It’s our own tool, but we want to make sure that it makes sense. We want industry to help share data and have been working with our industry.”

The e-Protocol Writer was developed in conjunction with the FDA and TransCelerate Biopharma, a consortium of 20 large biopharma companies. The partners aimed to incorporate industry input into the design of an electronic protocol template based on TransCelerate’s Common Protocol Template (CPT), developed in 2016.  

CPT aims to enhance clinical trial processes by developing common content for reuse across clinical trial documents, with the goal of eventually creating electronic, machine-readable documents and improving overall efficiency. 

“CPT has been downloaded nearly 9,300 times,” said TransCelerate in a comment. “In terms of demographics, biopharma companies are our most frequent CPT procurer, with a mix of government agencies, major cancer centers and independent researchers around the globe also regularly accessing this tool.”

E-Protocol Writer takes the concept a step further, providing an online platform for sponsors and investigators to collaborate on one consistent version of the protocol. Users can track the progress of the protocol, share comments with other team members and keep accurate version control. Email notifications alert the team when a protocol section is ready for review.  

The tool consists of 10 sections that cover all elements of a protocol:

1. Protocol summary;
2. Introduction — study rationale, trial background and risk/benefit assessment;
3. Objectives and endpoints;
4. Study design — scientific rationale and justification of dose;
5. Study population — inclusion and exclusion criteria, lifestyle considerations, screen failures, and recruitment and retention strategies;
6. Study intervention — bias minimization, handling of investigational product and concomitant therapy;
7. Discontinuation of study and/or patient;
8. Study assessments — efficacy, safety, adverse events and unanticipated problems;
9. Statistical considerations — hypotheses, sample size, population for analyses;
10. Supporting documentation — regulatory, ethical and study oversight considerations, and protocol amendment history.

E-Protocol Writer also facilitates submission of protocol information to ClinicalTrials.gov.

The tool has evolved with developments in clinical trials. “We did update recently the behavioral template to include observational studies,” said Jorgenson. “These kinds of studies tend to have a unique different design, so we customized the template to help those investigators.”

View the tool here: https://bit.ly/2Se4I02.