Risk-Based Approach to Monitoring: The Value of Data in Clinical Studies

Patricia Santos Serrao

Note: The views expressed in this article are those of the author and do not necessarily represent those of her employer, GxP Lifeline, its editor or 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 The agency adds that "because existing and recently withdrawn guidance may not clearly reflect FDA's current recommendations regarding monitoring practices, we recognize that we must clearly articulate our recognition of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.

Statistical information is important in a clinical trial not only to evaluate the safety and efficacy of a product but to understand where quality can be improved, efficiencies increased, and risk minimized.

Most of us are familiar with the expression "garbage in, garbage out," meaning you get out what you put into something. Nowhere is that truer than in data collection and data analysis. However, users of computerized systems are often resistant to entering information into systems and are frustrated with systems that mandate information be entered as part of the use of the system. The ability to quickly and easily demonstrate the benefits that can be had from entering this information can significantly reduce this resistance. We all have different perspectives of how we view information and what information is of value to us based on our roles, responsibilities, and functional area.

Throughout the life of a clinical trial the information collected is abundant to say the least; however, it has little usability unless it can be analyzed in various ways. Statistical information is important in a clinical trial not only to evaluate the safety and efficacy of a product but to understand where quality can be improved, efficiencies increased, and risk minimized. Process management solutions, such as MasterControl's Process module, enable users to build sets of information-collecting templates that can be used to capture critical details via pick lists, checkboxes, dates and more. Process checklists can be used to document clinical monitoring visits (site qualification, site initiation, site interim visits, and closeouts) and these same forms can be used to document deviations and non-conformance activities as well as corrective and preventative actions if needed. With the correct type of information gathering, complex questions can be quickly answered and acted upon using data analysis based on information collected using process forms.

What if your clinical director could quickly and easily get answers to the following questions using a risk management tool that leverages the information gathered through a clinical trial:

  1. Which sites participating in this study have a lower-than-expected patient enrollment rate?
  2. Which sites currently have investigational product that will expire within three months?
  3. Which clinical investigators have not been retrained on the recent protocol changes?

All of these questions are critical to the quality of a clinical study and are examples of a risk-based approach to managing clinical sites, yet often this information is elusive at best, and there is no central location where a study director can go to find this information quickly and easily. Integrated tools, such as MasterControl's Clinical Suite, which bring together documents, process (i.e., monitoring, deviations, and CAPA), risk management, and more can provide all of the risk-based approach information needed for a clinical trial in one centralized location.

Patricia Santos-Serrao, RAC, is a Life Sciences professional with almost two decades of experience in Regulatory Affairs and Clinical areas of the Pharmaceutical Industry.

Prior to joining MasterControl, Patricia held the position of Manager, Global Regulatory Solutions for QUMAS, a company specializing in quality and compliance management software for Life Sciences, where she helped drive the development, sales, marketing and implementation of solutions for the R&D areas of the Pharmaceutical Industry with a particular focus on submission document management for Regulatory Affairs, and Clinical Trial Master Files (CTMF) for Clinical.

She's worked for several Tier 1 pharmaceutical companies, including Schering-Plough and Boehringer Ingelheim, both in Regulatory Affairs and Clinical. She's assisted various pharmaceutical, biotechnology and medical device companies in implementing electronic document management and submission solutions, and in compiling eCTDs, and other submission format filings worldwide. A graduate of Western Connecticut State University and University of Phoenix, Patricia holds a Bachelor's of Science degree in Business Administration. Patricia is a member of Regulatory Affairs Professional Society (RAPS) and Drug Information Association (DIA). She has also earned her Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) and the Regulatory Affairs Certification Board (RACB). You may reach her at psantosserrao@mastercontrol.com.