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Who’s Afraid of Risk-Based Monitoring?

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I was recently asked what is preventing a rapid transition to risk-based monitoring. While the relative newness of the process is often blamed for the slow rate of adoption, I believe that psychological factors based on misperceptions—including the fear of the unknown—may be the primary reason.

Now the pertinent question is: how do we address these concerns and eliminate the fear? First, let us remember that risk-based monitoring is not a “grassroots” initiative. For many it has been a directive by senior management, often without sufficient guidance and training being provided. Senior management needs to recognize that during this time of financial upheaval, outsourcing abroad and growing fear of government control, clinical trial office managers (CTOMs), clinical project managers (CPMs) and clinical research associates (CRAs), rationally or irrationally, are more concerned about retaining their jobs than about potential cost savings for their trials—even if the potential savings could reach as high as 20 percent of clinical trial budgets.

Let us consider a CRA’s position for a moment. They have been told all their lives that the FDA will issue a “refusal to file” even if only minor errors are found. Over the past 20 years, they have become expert “box-checkers” as management desired them to be. Some of them even advanced very high in their organization, performing their jobs as they had been trained. Now, someone else suggests that they would serve their organizations much better by doing their jobs in a very different manner—after years of doing it that way—without an adequate explanation as to why or how to do it differently. Clearly the fear at the study team level is very tangible and real, resulting in very slow changes in clinical operations. Change will continue to be slow until a noticeable investment is made in retraining and education.

Presumably, there may be numerous misperceptions holding clinical operations back. The next logical question is which specific misperceptions are slowing the rate of adoption of targeted source document verification (SDV) more than the others. I believe the main misperception is a misunderstanding by many CRAs and data managers (DMs) that the manual query process should NOT precede the SDV step (although they are and should be truly independent of each other). Many companies trust this sequence of steps (i.e., SDV first, then DM cleaning) so much that they even configure their electronic data capture (EDC) systems the way that makes manual queries impossible unless the SDV step is completed first (i.e., box is checked in EDC). This false belief is a large obstacle that needs to be eliminated. This seemingly trivial change carries a lot of weight in the process design; thus, this first step will open the door for more dramatic subsequent changes. I would argue that if the DMs are given rights and encouraged to start issuing queries prior to the SDV step, then the current role SDV serves as a data quality step will naturally diminish. SDV as a supporting mechanism for query resolution still plays a role – what I’m referring to here is the role of SDV as a query-independent, stand-alone step.

In summary, I do not see any significant efforts on the “industry lieutenants’” side to convince their staffs that risk-based monitoring is the way to go. I see many companies working on bits and pieces (such as “new SOPs”). However, these efforts are not commensurate with the challenge at hand. More specifically, no sufficient effort has been made to assess the situation formally and, first and foremost, focus on the training and education needs of clinical operations. It is quite clear that currently the “workers” are not on the same page as the “lieutenants” with respect to risk-based monitoring. If the “workers” are not sold on the new idea, the implementation will not happen.

Guest blogger Vadim Tantsyura is an independent consultant, and specialist in clinical data science and clinical trial operations management currently working for a top five global pharmaceutical company. His research has focused on the areas of EDC, data quality, cost-effectiveness, cost of quality and risk-based approaches to clinical trials. He is a lead author of the “Risk-based Source Data Verification Approaches…” paper published in the Drug Information Journal in 2010, which is referenced in the recent regulatory guidance on the risk-based approach to monitoring of clinical trials.

If you want to hear more from guest blogger Vadim Tantsyura check out his recent Bio-IT World podcast with Geeks Talk Clinical contributor Steve Young, “Ride the Wave of Risk-Based Site Monitoring.”

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