Regulators will soon require sponsors and CROs to demonstrate that they have effectively anticipated, managed and mitigated risk during the course of each study.
Identifying and then setting your end point as the target is the most likely way to achieve success. We have to know where we want to end up in order to plan and achieve an efficient route to success.
Evidence of the conduct of risk assessment, risk detection and risk management throughout the life of a trial is required for compliance to ICH E6 Rev2. The process will be cyclical through the life of a trial. Adherence to a single rigid plan will not achieve success – the plan and actions must adapt to changing information/knowledge and the trial environment.
How do we get started when we can’t predict what conditions may arise in the future?
Start by putting a plan in place with the information at the time, and then for as long as it is relevant to do so. Change it as needed but be sure to document the decision to change, including the reasoning. Ending up with evidence of adherence to the plan, of adapting to changing conditions and knowledge, and of the success of the measures taken is the end goal. Plan with that in mind! At the end of a study, the regulators will not know what a great job you’ve done if you cannot show them this evidence from the life cycle of the trial.
If evidence is the end point, what will you use to show the cyclical assessment, detection, management, decision making and efficacy of each over the course of your study?
How Do I Find Out More?
Here at TRI we are experts in both helping companies become compliant to ICH Rev 2 as well as running clinical trials in a compliant manner. If you’d like to know more about our simple, pragmatic approach, please just contact us by clicking on the email link below:
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