Blogs

For the last 2 days of the Clinical Trial Oversight Summit, one of the tracks focused on Clinical Auditing.  To kick-off this track, Dr. Jerri B. Perkins addressed the group on the topic of Change at FDA Brings Challenge to Industry.  Dr. Perkins is a former FDA Medical Officer, and her insight into their view of all things Risk-Based was a true highlight of the conference.

Dr. Perkins provides some interesting insight into why the FDA is encouraging a RBM approach.  The FDA itself has realized that it cannot do everything it would like to do, and that it had to get focused to function.  Because it has gone to a risk-based approach inn its own processed, it has clarified that it would like industry to do the same. Of course the risk of RBM is not on the FDA, the risk is for industry to implement these types of monitoring plans, and there is no one-size fits all. 

She also gave the perspective as to how the FDA looks at a study that has been submitted.  The FDA starts with the overall, or global, view of the study.  What they see at that level tells them where they need to look in more depth.  She pointed out that sponsors and CROs can become very focused on sites individually without looking at them in the context of the study as a whole.  She encouraged sponsors and CROs to really start at the top.  Data that is too good or too bad should be easily identified from that level, and should guide where to focus attention.

There are three things that the FDA is focused on: 1) patients are protected; 2) data integrity; and 3) well conducted trial.  Additionally, the FDA expects a sponsor to prospectively identify how and what will be monitored in the area of proper consent of subjects, protocol adherence, product accountability, documentation of procedures and assessments, as well as how the blind will and was maintained during the execution of the study.  So what can a sponsor do to look at their study the same way the FDA will?

Incorporating Patient Profiles and QueryMap as part of the monitoring of a study can help improve data quality and trial conduct.  Use of QueryMap provides qualitative means to track and improve the data quality.  It also provides tools to quickly identify obvious errors and areas where there may be a protocol compliance issue that needs to be addressed.

QueryMap, as part of centralized monitoring, allows monitors during on-site visits to spend time on processes that may not be directly related to the data such as reviewing the process for informed consent, overall study documentation and site processes.  This all contributes to higher quality data, as well as overall study conduct.

By including data quality metrics in the monitoring plan, quickly identify what sites and patients need more attention.  Instead of the randomly monitoring every 2^nd or 3^rd patient at a site visit, monitors know exactly which patients data to spend time on before they arrive at the site. Monitors go to the sites armed with the profiles of the patients with the most issues.