FDA and NIH Release the Best Free Tool to Write Clinical Protocols 
​[Posted on: Thursday, May 4, 2017]

This week, FDA and NIH released a template for clinical trial protocols that practically took away any excuses one may have to not write a good quality clinical protocol. This template was jointly developed by clinical trial experts at NIH and FDA for government-funded researchers, in collaboration with a non-profit group that was developing a similar template for industry-sponsored investigators. A draft of this template was released last year which received about 200 comments from the potential users culminating in the final version. The result is an excellent template that could potentially become the gold-standard for all clinical protocol writers. To top it off, NIH and FDA also released an online tool to semi-automate the creation of a clinical protocol document using a simple question and answer-based online form. One NIH-blogger called this “Electronic Protocol Writing Tool” as the “TurboTax for clinical trial protocols”. The online tool can be used by anyone for free; there is no need to download any software, and the writers can easily create an online protocol team to collaborate in writing a clinical trial protocol. An author can create multiple protocols with several reviewers, and in the end could generate fully formatted professional documents. The tool is highly intuitive, easy to navigate, and comes with good instructions and guidelines. It took this author less than an hour to create a fully functional draft protocol from a synopsis and inform all the reviewers about the existence of the protocol draft being ready for review. The blogs and news releases out of NIH and FDA deservingly show how proud the two organizations are of this template. The impact of this tool could be enormous. A survey on the clinicaltrials.gov registry shows that about 77% of all open trials or about 41,000 clinical trials are funded either by the US government or universities/individuals. Of these about 20% or about 9000 are Phase 2 and 3 clinical trials. Majority of these government-funded or non-industrial sponsored trials lack proper clinical protocols. The regulations describing clinical protocol only provide a general outline of what a protocol should include but do not provide detailed instructions, thereby leading to diverse interpretation of the regulatory requirements and clinical protocol of all qualities which though legally valid are inadequate for robust review. Although protocol templates exist from diverse sources, the NIH/FDA template provides a template with the most recognized and respected credentials which should get much wider acceptance by writers. More importantly now that NIH and FDA have a formal template, they can encourage (read “push”) all government-funded researchers to use it for easier review and more acceptability for funding. And with the free online tool, not only resource-limited writers but anyone can easily create a high quality document.