Writing Clinical Study Protocols

The basis and success of any drug or device development program is the clinical trial protocol. Clinical trials conducted under an IND or IDE cannot begin without a protocol, and yet there is variability between companies and individuals on how to approach writing this critical document. Clinical trials and entire programs have failed because the protocol was not scientifically sound. Knowing how to effectively research and write a clinical trial protocol is essential to a compound achieving IRB and market approval.

Over the course of a development plan, new protocols, amendments, and concept sheets will be needed. Protocols for Phases 1, 2, 3 and 4 require different writing approaches and you must know what the agency expects at every development milestone to avoid the trial being put on clinical hold. Moreover, amendments, however unwelcome, are a necessary part of the development process.

• Describe the overall structure of a protocol and regulatory requirements
• Describe the requirements for a protocol, including:
        o Establishing the indication(s)
        o Types of studies
        o Design (single blind, double blind, randomized, etc.)
        o Establishing the hypothesis
        o What is safety and efficacy and how do you establish either or both
        o Determining inclusion/exclusion criteria
        o Determining the Schedule of Events
        o Adverse and Serious Adverse Event reporting

• Medical Directors
• Medical Writers
• Clinical Research Associates
• Regulatory Affairs Professionals
• Research and Development Personnel