In today’s clinical development landscape, more and more clinical trial designs are including a specialized oversight component on accumulating data that utilizes medical and/or statistical experts who operate within a committee structure according to charter-defined rules and procedures.
Two of the most popular types of Expert Committees used in current clinical trials are the Endpoint Adjudication Committee (EAC) and the Data Monitoring Committee (DMC). At a high level, both types of committees are responsible for performing data reviews and providing expert assessments that could potentially impact the continuation of a trial and/or the final results of the trial. With so much at stake, it is critical that these committees are properly established and expertly managed so the intended purpose can be achieved.
Due to evolving practices and increased regulatory attention on Expert Committee operations, trial sponsors must recognize both the importance and the benefits of outsourcing their committee management functions to an independent provider.
Benefits of Outsourcing Expert Committee Management to an Independent Provider
- Clear Firewall
As part of their responsibilities, Data Monitoring Committees and Safety Assessment Committees have access to unblinded data. Everyone involved with unblinded data must be entirely independent from the clinical trial operations as the information could influence actions and risk the integrity of the trial. This is taken very seriously by the regulatory agencies as well as most quality assurance and compliance groups. Some sponsors and CROs attempt to use separate teams for trial management and DMC management but this still introduces a risk to the program as the teams could easily talk. The better option is to outsource to a separate independent provider that specializes in managing expert committees that use unblinded data.
- Member Relationships
Sponsor relationships with their committee members can be a sensitive topic. Committee members are often selected for their expertise in the field of study and sponsors may therefore feel strongly that they should always have positive interactions with these members to maintain their connection to the product. This dynamic makes it very challenging for sponsors to appropriately pushback and manage the members. A better option is for the sponsors to keep an arms-length relationship with the members while relying on a third party company to set expectations with members, manage disputes, make payments, etc.
- No Perception of Bias
The clinical development industry upholds the scientific integrity of clinical trials and the research process. Whether substantiated or not, there is a common perception of bias when oversight functions are managed by the same group managing a trial because there is a conflict of interest between taking difficult and/or costly actions to do what is right for a trial versus doing what will propel the drug forward to the next milestone. In the absence of an independent, objective and unbiased company managing the Expert Committees, regulatory agencies have been known to take additional precautions to ensure validity of the trial results and committee conduct.
- Quality Control on Trial
As Expert Committees are tasked with review of accumulating study data, they can also serve as a quality control check on the trial itself. For example, DMCs may identify data outlier trends specific to particular study sites that could point to fraudulent conduct and warrant further investigation. EACs may find that certain sites consistently do a poor job uploading required source documents, resulting in a high percentage of non-assessable events. If these types of situations arise with a committee that is managed by a sponsor’s internal clin-ops resource as part of the countless other responsibilities on their plate, the trends may go unnoticed and uncorrected. However, independent specialty providers focus deeply on metrics in the trial process and trends in data reporting and member voting as they could help with early identification of risks to allow for midcourse corrections as needed.
- Time and Cost Savings
Expert Committee management can be a complex process with multiple moving parts. The industry has seen a huge number of “rescue” committees that were conducted poorly, numerous trials that were unnecessarily stopped by mismanaged DMCs, failed trials due to low-quality adjudication committees that did not have a consistent methodology for endpoint assessments, and so on. On top of the significant time and cost delays in getting these drugs to market, many CROs scramble to keep up with the complexity of committee management and end up with negative profit margins on their projects. By comparison, independent specialty groups like ACI Clinical tend to have deep staff expertise to guide clients through a well-documented, cost-effective process that is measured and frequently reported on throughout the project to ensure the most value for the budget.
Expert Committees perform critical oversight functions on clinical study data. It is important that these committees are managed well by someone who understands all the aspects involved with enough expertise and availability to truly focus on what is needed.
Independent specialty groups that manage Expert Committees can provide the ideal outsourcing alternative for the most consistent and effective results.
ACI Clinical can support any of your EAC and DMC needs. Contact us today to learn more.