The NIH and the FDA last week announced a draft clinical trial protocol template to help clinical investigators save time, and to encourage more investigators to engage in research. BRANY\u2019s own research indicates that clinical researchers find writing protocols to be both time-consuming and difficult. Any tool that makes it more efficient for researchers and improves the quality of research protocols for institutions will benefit research overall.<\/p>\n
Over half of researchers have access to templates from their institutions. Often they can download them from Web sites. These can vary from one institutions to the next. A standardized \u201ccommon protocol template\u201d approach, such as the FDA and NIH are proposing, can go a long way to alleviating delays and improve protocol design.<\/p>\n
Additionally, while institutional templates may provide general content about the elements of a trial protocol, few of them provide the step-by-step guidance necessary to improve the efficiency of protocol-writing. A guided experience that walks investigators through the steps of building a protocol and provides expert advice, examples and suggestions can go a long way to helping an investigator prepare a high quality and complete protocol ready for IRB review.<\/p>\n
A well-written clinical trial research protocol is important for the success of any clinical trial; it can also speed up the process of regulatory review and IRB approval. We look forward to watching further developments from the FDA and NIH on this important initiative.<\/p>\n