Oversight of Clinical Investigations – a Risk-Based Approach to Monitoring

I am pleased to introduce to you Lori Muir, one of our fabulous MLC, LLC team members! Lori holds a BS in Chemical Engineering from Syracuse University.  She has 22+ years industry experience and maintains professional certification from ACRP as a CCRA.  She started her career in product/process development and processing engineering in the Biotech and Pharmaceutical Industries.  She then moved onto clinical research and gained experience as a CRC, CRA, CPM, and most recently held the position of Director of Clinical / Regulatory Affairs for a life sciences CRO that managed clinical studies for the In Vitro Diagnostic Industry.

Take it away Lori!!

The FDA has finalized guidance on clinical trial oversight, calling for more remote and target risk-based monitoring.  The agency has taken into account advances in technology and the need for cost-effective and efficient trials.  So what does this mean to Sponsors and Investigator Sites?

The FDA guidance made it clear the agency supports a variety of styles of monitoring, that each study design should be based on risk factors related to that study, and that a single study may combine a variety of monitoring styles to be successful.  With the frequent use of electronic data capture (EDC), remote oversight and trending of data may prove to be even more valuable to identifying outliners, unexpected trends, or holes in study data collection.

These risk-based monitoring (RBM) plans focus more attention on centralized monitoring oversight and reduced onsite monitoring.  Centralized monitoring is what the FDA is referring to as monitoring of data offsite, through remote monitoring, statistical analysis, and real-time review.  This centralized monitoring may be a more efficient and cost-effective way to pull out quality issues at a site.  The plan should clearly outline what level of quality the clinical site must adhere to so that centralized monitoring can replace onsite visits.  Specific data points or examples of violations that affect study validity and patient safety can be outlined in the plan to clearly define an acceptable shift in monitoring style.

Numerous pharmaceutical and biotechnology companies have publicly stated they have initiated pilot RBM programs however these are still in their infancy.  Therefore it’s too soon to report whether these approaches have led to more efficient use of resources or increased quality.  However it is apparent that this change in monitoring scheme will impact the investigator site community. There is definitely a need for raised awareness regarding the importance of sponsors partnering with clinical site representatives when developing these RPM models.  These discussions should include considerations of the impact the monitoring approach may have on items such as workload, timeliness of data entry, and site budget.

What are the positives:  Allows clinical researchers to take advantage of technology; to expand opportunities for quality to be driven from the study as a whole (not just from data point to data point); and to collaborate, share experiences and lessons learned, and promote a new culture of clinical monitoring.

• Investigator sites are critical stakeholders in the clinical development process and therefore should be an integral part of the conversation around the development of RBM models.
• Sponsors and sites need to recognize that the success of RPM is shared. Open communication between the site and the sponsor is KEY to drive the standards of clinical trials to a new level of quality and safety through these collaborative initiatives and problem-solving.
• Many investigator sites misunderstand how RBM is defined and what is intended to accomplish. Sites may perceive that that RPM methods will lead to increased burden on clinical site personnel.