Not all studies require a data safety monitoring board (DSMB) or a clinical events committee (CEC). But should they be implemented for your study, it’s important to know they are not all created equal. The Data Safety Monitoring Boards (DSMB) review cumulative information from a study and monitor safety oversight with teams of independent physicians and medical professors. Clinical Events Committees (CEC) adjudicate finite sets of adverse events within a study to determine if those events are related to the study or not. While it is critical to understand the primary purposes of a DSMB/CEC, you should also look beyond meeting basic requirements in order to be the most confident in your efforts for patient protection and study results.
Examine these qualities when assembling a safety management board and consider if the DSMB/CEC (and the Administrator) provides:
- Consistency and Organization
- Credibility and Experience of the Board Members
- Time and Availability Required to Fulfill the Duties of Maintaining a Board
- Attention to Detail
- Meeting Flexibility
With these in mind, one consideration for managing your DSMB/CEC and comprehensively addressing this list is a Contract Research Organization (CRO). Utilizing an independent, third party outside of your organization can offer numerous benefits. Having a CRO can establish a “firewall” between the Sponsor and the safety management boards, therefore freeing the sponsor and study of any additional scrutiny for potential for bias. An independent CRO to administrate also promotes objectivity that benefits the safety of the subjects and the integrity of the trial.
The CRO can also offer another layer of independence through assessing Conflicts of Interest (COI), managing member agreements, and managing member compensation. An independent administrator brings consistency and organization through standardized procedures and because managing your safety boards are their primary concern.
Rather than having a DSMB/CEC that tries to run itself with physicians that are already busy, a CRO is available to deliver reliable results in a timely manner. Critical timelines, reports, notifications, and follow-ups don’t get behind and are maintained seamlessly. Your physicians are able to focus then on their areas of expertise without distraction. And if meeting location can be an issue, a CRO can organize remote or local sessions. This also offers the flexibility to work with individuals from not only across the country, but around the globe providing a greater network of respected therapeutic expertise to use for your study.
A DSMB or CEC is an investment in safety and data integrity that goes beyond checking a box. Seek qualities in your safety management team that will be sure to add value to your important study.