Are You Conducting Proper CRO Oversight?

By Ed Miseta, Chief Editor, Clinical Leader

Are my CROs doing what I hired them to do? That is a question you may have asked yourself many times. Even if you have conducted a thorough CRO search and selected the one that best meets your needs, there is no guarantee it is performing the tasks most important to your clinical trial. That is why conducting proper oversight of your CRO is so important.

Clinical technology provider Comprehend recently released its CRO Oversight Benchmark Report, a survey of sponsor companies that looks at the challenges and best practices relating to CRO oversight. The survey questioned over 100 clinical operations leaders from global life sciences companies. The results were enlightening, and there was strong alignment around the goals, challenges, and best practices of the companies taking part.

Clinical outsourcing has been increasing in recent years, and the results bear that out. Over half of the respondents currently outsource to three or more CROs. Ninety percent of the surveyed sponsors plan to increase their use of CROs, 98 percent indicated CRO oversight is a top priority, and 93 percent indicated they have real investment behind it. Still, only 22 percent indicated they have confidence in their CROs ability to hit milestones on time and with a quality result, two of the top concerns for sponsors.

What, Exactly, Is Oversight?

At the conclusion of an FDA GCP (Good Clinical Practice) inspection, a comment that is often found on 483 forms issued to sponsors has to do with “Failure to ensure proper monitoring of the study.” It is a brief but also potentially damaging statement and illustrates the importance of sponsors properly overseeing their CROs. At a minimum, sponsors must be able to tell a regulatory inspector that its CRO did what it was hired to do. Drawing that conclusion would be next to impossible without proper oversight.

The CRO Oversight Benchmark Report lists four questions that are fundamental to CRO oversight:

1. Is my CRO doing what I hired it to do?
2. Is the CRO adhering to the quality plan?
3. Is CRO performance meeting or exceeding expectations?
4. What issues should be escalated?

At any given point of a trial, but especially at the end, sponsor representatives must be able to explain where they are in the project and how they got there. The report further notes that monitoring oversight and CRO management have been a focus of regulatory inspections and are also at the center of the recent ICH E6 updates.

Oversight: An Overlooked Priority?

 Although CRO oversight is a priority for most sponsors, the survey found that only 34 percent of clinical operations leaders indicated they successfully achieved their planned CRO goals. Furthermore, only 22 percent were confident that their CRO would achieve milestones on time. Respondents were also asked about CRO-related risks that kept them up at night. Missed milestones were the number one response, followed by data quality. When asked why CRO oversight was a priority, the top responses were avoiding trial delays, managing quality, meeting compliance requirements, and reducing cost and risk. Clearly, CRO oversight is necessary for achieving quality and timeliness.

Part of the shortfall in achieving CRO oversight goals might have to do with the funding applied to it. Considering the importance of CRO oversight, you would expect those efforts to be funded as fully as possible. However, 49 percent of respondents noted they have an average amount of investment in CRO oversight. Only 19 percent indicated they had full investment, and 32 percent of respondents indicated they had limited or insignificant investment.

Finally, although quality and timeliness were the top two concerns of sponsors conducting CRO oversight, respondents did note three processes that would have to improve in order to increase the speed to a quality result. The first is subject enrollment, including management of each stage of the enrollment process, from screening to completion. Respondents noted there are several questions they require answers to, including:

1. Why is enrollment lagging?
2. Which sites have been active the longest and with the lowest enrollment rates?
3. How is that affecting enrollment actuals versus plans?
4. Do we need to retrain sites or increase investment in key regions?

The second process in need of improvement is subject compliance. This includes management of protocol deviations, adverse events, and subject visit compliance. In this area, the respondents noted they would like answers to these questions:

1. Where are the risks?
2. Is the increasing protocol deviation rate across sites or specific to a region or set of sites?
3. Do we need to retrain sites and amend the protocol?

The third process is site productivity, including management of query, data entry, and query resolution rates. In this area, sponsors noted they need to know which sites generated higher than expected queries and whether increased site contact reduced outstanding queries.

To evaluate each of these core process areas, the survey asked respondents both how important and how successful they are in each area. Despite the fact that 100 percent of respondents indicated they are funding initiatives to improve speed and quality in collaboration with their CRO, only an average of 30 percent believe they are successful in the CRO oversight key focus areas.

You can access highlights of the CRO Oversight Benchmark Report here. If you would like more information on how to select, oversee, and audit your CRO, plan to attend Clinical Leader Forum on May 10-11 in Philadelphia. We will have the experts on hand to help answer your questions.