Have your Phase 1 studies received proper risk mitigation planning?
Even in Phase 1 studies conducted with healthy volunteers, there are a number of potential risks which can be detrimental to the overall success of your study. While most Phase 1 units are likely to have Standard Operating Procedures which provide guidance on how to respond to emergencies or adverse events during a clinical trial, few sites are likely to develop Risk Mitigation Plans that are tailored to address specific protocols.
Sponsors and their sites should be working together collaboratively to develop comprehensive Risk Mitigation Plans for all Phase 1 studies they conduct. By creating a Risk Mitigation Plan, stakeholders are able to produce a documented, systematic approach to identifying potential risks before the trial has begun.
In this white paper, you will learn:
- Where potential risks can be identified within the protocol
- What factors outside of the protocol should be considered when determining potential risks
- What items to include in order to produce an organized, user-friendly Risk Mitigation Plan
After reviewing this white paper, you and your team should be able to develop a Risk Mitigation Plan which includes:
- Classifications and implications of identified risks
- Steps for mitigating risks
- Courses of action to be followed in the event a pre-identified risk does occur, also known as Contingency Planning
Additionally, through this document, you will find helpful examples of potential risks that could easily occur in Phase 1 studies without proper planning, as well as a sample of a Risk Mitigation Plan which you can use to model your own plans around in the future.
WCCT Global is a full service strategic development partner. Since 1998, WCCT has conducted well over 500 Phase 1 clinical trials at its corporate-owned Phase 1 unit in Cypress, CA, with experience in conducting large volume studies requiring over 200 patients. WCCT is the industry leader in Japanese bridging and has recognized expertise in multiple therapeutic areas, including Ophthalmology, Gastroenterology, Vaccines, and Influenza.
DOWNLOAD THE WHITE PAPER
White paper on creating a Risk Mitigation Plan for Phase 1 studies.