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 ultimately market approval.
Over the course of any development plan, new protocols, protocol amendments, and protocol concept sheets will be needed on an ongoing basis. Though they require similar information, protocols for Phases 1, 2, 3 and 4 require different writing approaches. As a writer of a protocol, you need to know what the agency expects to see 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. Amendments need to be managed efficiently to avoid costly implementation or delays to the ongoing trial.
- 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 (prospective, observational, retrospective)
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
- Research and Development
Meredith Brown-Tuttle, R.A.C.
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3 hours; 12:00 - 3:00 p.m. Eastern
May 4, 2011
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471