Custom-built protocols: planning and structuring a study to better serve the clinical research community

Authors

• BA Snow
• SL Kopka
• DG Chaitt
• JF Pierson
• TJ Miller

Abstract

To standardize protocols for FDA-regulated clinical trials, the NIH and FDA jointly published a protocol template in May 2017. This was accompanied by an electronic tool to fill out the template, described as “a sort of ‘Turbo Tax’ for clinical trial protocols.” These initiatives belie the complexities of composing a coherent and internally consistent protocol. Templates are a starting point, but a one-size-fits-all approach can obscure the features that make the protocol a cohesive document. Consider the process of building a house. Many communities offer a model home where the owner can custom design specific areas within the limits of the architecture and the local regulations. To have a solid foundation and design, you need to ensure experts are engaged, providing the necessary skills, and using the right tools. A dedicated team of protocol navigators and medical writers, such as the Protocol Navigation/Protocol Development Program (PN/PDP) at NIAID, provides such expertise to the investigator preparing to build a protocol. The success of the PN/PDP has led NIH leadership to plan to provide writer and navigator services to investigators within all NIH intramural institutes who conduct clinical research. Using the house-building analogy, we provide information on constructing a protocol that we have found useful in our projects, and examples of how more than just using a standard template is necessary to address the needs of a study.

Scientific Focus Area: Research Support Services

This page was last updated on Friday, March 26, 2021