Drug Accountability in Clinical Trials by Dr. Robbie Wong Pharm.D., Clinical Development Consultant and Affiliate Assistant Professor, Dept. of BioEngineering, University of Washington

It's not exciting, it's not cutting edge. It may be the last thing you think about when preparing for an FDA audit. You might scan the records and figure if all the lines are filled in, it must be okay. Or, the auditor might not look at it, so I will trust that the pharmacist did it correctly. After all, aren't pharmacists one of the most trusted professions? Consider this: if drug accountability is in question, then the whole study could be in jeopardy. Proving that the drug was administered to the patient that resulted in the effects seen from study drug is a key factor in determining the merit of a product candidate. The FDA has listed drug accountability as number three in a list of top five pitfalls.

The FDA uses these categories for determining the seriousness of a deficiency. Sometimes, minor sloppiness is due to poor recordkeeping. This can be corrected with training and close follow-up to ensure consistency among staff. Sloppiness, if bad enough, can cause removal of data from study results, impacting the overall quality of the data and the integrity of the study. Unintentional lack of attention to detail and ignorance of the importance of accurate recordkeeping in the drug application can contribute to a site's data being thrown out of a sponsor's application. Training staff at the study initiation visit and checking the quality of the work during the course of the study are critical for maintaining good recordkeeping during the clinical trial. Staff can change, so retraining may be needed as new staff members are added to an ongoing study.

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Risk-Based Approach to Monitoring: The Value of Data in Clinical Studies by Patricia Santos-Serrao Senior Product Manager, Pharmaceutical Industry, MasterControl, Inc.

In August 2011 the Food and Drug Administration (FDA) released a guidance entitled "Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring," which highlights a new approach to clinical site monitoring different from that of years ago. In this most recent guidance, the FDA openly states that "Many sponsors have understood that FDA expects sponsors to conduct frequent on-site monitoring and 100% data verification for all trials," clarifying that this is not always the best approach or the most productive use of time. The agency adds that "because existing and recently withdrawn guidance may not clearly reflect FDA's current recommendations regarding monitoring practices, we recognize that we must clearly articulate our recognition of the value of alternative approaches to facilitate change in industry's monitoring practices." This new approach to risk-based monitoring increases the importance of data collection and the ability to quickly and easily track, trend, and analyze information captured as part of clinical monitoring and other quality-driven activities during clinical trials.

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Trends in Q1 FDA Warning Letters by Cindy Fazzi Marketing Communications Specialist, MasterControl, Inc.

If you work in the life science industry, it is always a good habit to periodically check the FDA's website for enforcement actions and warning letters. You can glean important insights from the mistakes and weaknesses of other companies in your industry, maybe even your competitors. You will see what the FDA is emphasizing in inspections, perhaps see some trends.

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