New FDA Guidance – A Risk-Based Approach to Monitoring Clinical Trials

• Regulatory Affairs

As clinical trials have become increasingly complex, clinical trial oversight has become more difficult to standardize. In response to this challenge, the FDA recently issued a new guidance that aims to assist sponsors of clinical trials in developing monitoring strategies that utilize a risk-based approach.

While no single monitoring approach is appropriate for each and every clinical trial, the FDA’s current thinking points to specific characteristics of monitoring plans that should be applied across all trials.

Guidance for Monitoring Clinical Trials

Here are some key points from the new FDA guidance:

• Centralized monitoring
  • Greater use where appropriate; on-site still necessary in many situations
  • Specific activities include those that can be easily standardized
  • Processes must be well-defined and ensure timely access to data and documentation

• Focused and risk-based monitoring; risks assessed and prioritized based on:
  • the likelihood of errors occurring
  • the impact of such errors on human subject protection and trial integrity
  • the extent to which such errors would be detectable

• Focus on critical data and processes
  • Informed consent appropriately obtained
  • Adherence to eligibility criteria
  • Appropriate product accountability
  • Assessments of study endpoints, safety measures, and adverse event reporting
  • Conduct to ensure trial integrity

This guidance may be met with resistance in some circles; however, we recognize the importance of employing risk-based monitoring.

At Medelis, we strive to ensure our clients are aware of the FDA’s current thinking on all topics relating to their clinical trials. The trials that we oversee are carefully managed to accommodate the FDA’s current stance, and we have a special regulatory approval consulting offering for those sponsors who seek additional expertise for preparing strong regulatory submissions over the lifetime of their product.