Drugs

Comments on Risk-Based Trial Monitoring

Pfizer says it supports risk-based approaches to clinical trial monitoring that can realize new efficiencies and facilitate strategies for clinical trial design and conduct. In comments on an FDA draft guidance on a risk-based approach to monitoring of clinical investigations, the company commends the authors of the guidance “for this generally helpful document that describes a risk-based approach to monitoring clinical investigations with meaningful detail and a clear statement of expectations in most sections.” General areas cited by Pfizer where industry would welcome additional information or clarification are inspections, identifying risk to good clinical practice, measuring success of a risk-based approach, additional stakeholder engagement, and clarification of control in the risk-based monitoring context.

The Society of Quality Assurance says the guidance’s question-and-answer format is considered to be useful. It says there are a few areas that either add confusion or would benefit from clarification and also says the draft would benefit from a greater alignment to the International Conference of Harmonization GCP (R2) to ensure that international trials are consistently managed and conducted. “In particular, the monitoring plan and a quality risk management plan did not seem to be sufficiently distinguished in the draft guidance,” it says. The society also offers specific line-by-line comments.

The Association of Clinical Research Organizations says the guidance does not resolve industry questions about the definition of central monitoring. “Specifically,” it says, “does centralized monitoring include traditional data cleaning activities, like listing reviews, programmed complex edits, frequencies, etc., in addition to newer technology-enabled activities, such as statistical analyses, key risk indicators, outlier identification?”

Cook Group provided specific line-by-line comments.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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