Not all studies require a data safety monitoring board (DSMB) or a clinical events committee (CEC), but these two independent groups can add tremendous value to your safety monitoring strategy.
Data safety monitoring boards review cumulative information from a study and monitor safety oversight with teams of independent physicians and medical professors. Clinical events committees 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 or CEC, maintaining a good working relationship with these groups requires more than just regular meetings.
A contract research organization (CRO) can help recruit and manage your DSMB or CEC.
Here are three big benefits of hiring one to support your work with safety monitoring groups.
Why Hire a CRO for Your DSMB or CEC?
1. To recruit qualified boards
A DSMB or CEC is an investment in safety and data integrity that goes beyond checking a box. You need to look for experienced team members who will add value to your study. A few important qualities include:
- Consistency and organization
- Availability to fulfill required duties
- Attention to detail
If this is your first time sponsoring or managing a study that requires a DSMB or CEC, you may not know how to go about assembling one.
An experienced CRO will have established relationships with independent physicians, which will make the recruiting process faster and easier. They can help vet candidates and ensure they are prepared when it's time to get started.
2. To eliminate bias
A CRO can establish a “firewall” between the sponsor and the safety management boards, freeing the sponsor and study of the potential for bias. An independent CRO promotes objectivity that benefits the safety of the subjects and the integrity of the trial.
The CRO can also offer another layer of independence by assessing conflicts of interest, managing member agreements, and managing member compensation. An independent administrator brings consistency and organization through standardized procedures.
3. To maintain communications
Physicians are busy enough fulfilling their day-to-day responsibilities. Asking them to manage a DSMB or CEC is asking a lot. But as a study sponsor or principal investigator, you already have a full workload yourself.
Spending time following up with physicians, scheduling meetings, sharing reports and ensuring your board or committee meets critical deadlines is a lot to ask.
A CRO can serve as a single point of contact for all communications to keep things moving forward.
That includes setting regular meetings, hosting them remotely if needed, and following up with everyone involved.
They can record and transcribe meetings, distribute data to the appropriate parties, and ensure everyone has the information they need for effective safety monitoring. They can also work with your statisticians or data safety management team.
This allows you and your physicians to focus on your areas of expertise without distractions.
One Team To Manage Safety and Data
Outsourcing safety and data management to an independent CRO like IMARC Research offers many advantages.
Our team can help you assemble a DSMB or CEC and serve as a single point of contact between these groups and other key stakeholders, including data managers. In addition to helping you select an electronic data capture system, we can work with monitors to ensure your trial data is entered in a timely, accurate manner.
We can also sort, clean and analyze your clinical trial data and assist with database locking as your trial comes to a close.
You have enough on your mind without worrying about finding qualified physicians for your data safety monitoring boards or following up with them after each meeting.
Let us manage these communications so you can focus on bringing your device to market faster. To see how we can help, schedule a consultation with us.