Writing US FDA-acceptable Clinical Trial Protocols

Purchase Options

The clinical trial protocol is a multi-dimensional document that plays a critical role in the success of a clinical trial. There are many schools of thought about the best approach to writing a clinical trial protocol depending on individuals or organizations sponsoring a given clinical trial.

Per FDA and ICH guidelines, a clinical protocol should be based on sound scientific rationale, conducted in a suitable population, include all appropriate procedures that help meet the endpoints, and be protective of study participants both physically and ethically. On an average about one of every three clinical trials fail to meet their primary goals due to poor design, faulty statistical strategy, lower recruitment, poor management of resources, and regulatory issues. Most of these causes of failure can be mitigated by a well-designed clinical trial protocol.

Irrespective of the Phase of a study, clinical trial protocols should follow some common rules. These rules are based on regulatory requirements, scientific logic, and practical experience. This webinar will walk the attendee through 10 critical steps in the development of a clinical protocol. Step-by-step instructions will be provided, with case studies to emphasize the common mistakes and potential solutions.

Why Should you Attend:
If you are involved in writing a clinical trial protocol, this webinar will provide valuable suggestions about various aspects of a clinical protocol from initial synopsis to various elements of the protocol, role of various personnel in finalizing the protocol, and troubleshooting common issues. The basic elements of a clinical trial protocol, the dos and don’ts of clinical trial procedures, development of a new protocol, amending protocols, scientific and ethical review of clinical protocols will be discussed. Also discussed will be role of interactions with the FDA, global clinical trials, and projected trends for the near future.

Objectives of the Presentation:
At the end of this webinar, you would understand:

• The overall structure of a protocol and regulatory requirements
• Identify who contributes to the protocol development and amendments
• The element of a protocol such a background scientific rationale, design (single blind, double blind, randomized, etc.), primary and secondary endpoints, inclusion/exclusion criteria, the Schedule of Events, adverse event management, statistical parameters, informed consent, and study synopsis
• Practical issues with protocol writing such a differences in various phases of clinical trials, the protocol review process, using key opinion leaders, and using public resources and templates
• Common issues with FDA and IRB approval of clinical protocols.

Who can Benefit:

• Sponsors of INDs
• Regulatory Affairs Professionals
• Senior Management Executives (CEO, COO, CFO, etc)
• Drug Discovery and Development Professionals (R&D and CMC)
• Clinical Trial Managers
• Project Managers and Clinical Trial Specialists
• Regulatory Compliance Associates and Managers
• People investing in FDA-regulated product development projects.

Instructor Profile: