If you are a current or prospective clinical researcher, I think you’ll be interested to know that NCCIH recently added two new protocol templates to the Clinical Research Toolbox, our web-based information repository for investigators and staff involved in NCCIH-funded clinical research.
The Toolbox already includes a protocol template recommended for NCCIH-funded studies. The new templates provide additional protocol strategies that you can use for specific kinds of NCCIH-funded trials:
- Phase 2/3 clinical protocols
- Behavioral and social sciences research.
Phase 2/3 Clinical Protocols
To facilitate the development of clinical trial protocols that require a Food and Drug Administration (FDA) Investigational New Drug (IND) or Investigational Device Exemption (IDE) application, NIH and the FDA worked together to develop a Phase 2/3 Clinical Trial Protocol Template. It is intended to help you think through the scientific basis of your assumptions, minimize uncertainty in the interpretation of outcomes, and prevent loss of data. This template is optional for NIH-funded phase 2 and 3 trials conducted under an IND or IDE application. Having a common protocol structure and organization eases the way for protocol review by oversight entities.
Behavioral and Social Sciences Research
The second new template is designed to support communication of the science, methods, and operations of a clinical trial in behavioral and social sciences research; efficient review by peers and oversight bodies; and reporting of related information into ClinicalTrials.gov. Other benefits of using a standardized template include helping to guide the replication of studies, and adherence to the International Conference on Harmonisation E6 Good Clinical Practice guidelines. I think that this template will be especially helpful if you are in the process of learning about the information and level of detail expected in a clinical protocol.
More Toolbox Resources
Overall, the Toolbox offers an array of templates, sample forms, guidelines, regulations, and other informational materials to help clinical investigators develop and conduct high-quality clinical studies. As you peruse it, you will notice that there are many resources for your study team as you prepare for study startup and implementation. We regularly update these offerings to keep up with changes in clinical research requirements.
The Toolbox is a popular part of our website, and we hope it will continue to help researchers. While we encourage you to use the templates, they are not required for NIH applications or contract proposals. If you have a comment about the Toolbox, please feel free to submit it below.