The Importance of Keeping DSMBs Independent
When conducting research, in some cases sponsors and contract research organizations (CROs) may involve a data safety monitoring board (DSMB), also referred to in regulatory documentation as a data monitoring committee (DMC). Per US Food and Drug Administration (FDA) guidance, DSMBs are supposed to be independent of the party who is conducting the research. This blog outlines when a sponsor or CRO can enlist a DSMB’s help, and why DSMB independence is critical to a successful study.
What’s a DSMB’s Role in Research?
First, let’s define what a DSMB is. A DSMB or DMC is an independent group of experts who conduct a periodic review of accumulated worldwide clinical data during a clinical trial. Their primary purpose is to report early evidence of benefit or harm found in a study, accounting for participant safety and data integrity and validity.
DSMBs are not typically formed for every single study; there are particular protocols where it is helpful to enlist one. Common types of studies with DSMBs include:
- Studies with placebo controls or studies where the investigator and/or sponsor are blinded
- Protocol is done on a high-risk population, such as pregnant women or the elderly
- Studies done in the oncology and/or cardiology field
- The product under investigation may have something that causes some type of harm or serious side effect
You can learn more about when a DMC or DSMB is necessary in our infographic When Do I Need a DMC?
Why is DSMB Independence Important?
FDA and European Medicines Agency (EMA) guidance is very clear – DSMBs should be independent of the folks who are conducting the research. The best way to accomplish this independence is to have a trusted third party administer the DSMB. In order for a DSMB or DMC to be most effective, it must be independent from individuals sponsoring, organizing, or conducting research. This is so the independent oversight body can provide an opinion without the appearance of implied bias.
Eliminating the Perception of Bias
Sponsors or CROs organizing and conducting the research can have a perceived bias toward showing an investigational drug works as expected. Having a stakeholder in this position also fill the DSMB role calls into question the true independence of such a committee. To address potential bias, guidance from the FDA and EMA suggests that an entity independent of the study sponsor provide this oversight.
An independent DMC can help erase bias perception and improve trust with regulators and the general public. Regulators especially recognize an impartial, third-party DSMB enables appropriate independence from those sponsoring, conducting, and organizing the research at hand. Additionally, sponsors and CROs can assure the general public that the study was done fairly and without any hidden agendas.
What is Charter Development?
The DSMB or DMC charter is a key part of establishing the committee, defining in advance how the DSMB will maintain independence from the sponsor.
Serving as a roadmap for trial oversight, a charter includes what exactly the DSMB will review, how often it will be reviewed, secure data flow, open and closed meeting procedures, and more. By laying out a step-by-step roadmap with information in terms of how the DMC will conduct itself and how the sponsor will interact with the DSMB, the charter helps describe roles and responsibilities, drawing clear lines between the sponsor and the independent review.
Not only does the charter keep everyone involved on the same page, but it is also useful for the sponsor when interacting with the FDA. A charter will become part of a DSMB record, so when the sponsor needs to provide information during an FDA filing, they can easily provide the charter to the FDA, along with specific meeting reports.
By ensuring the DMC is truly independent from study conduct, sponsors make trial data more trustworthy to regulatory authorities and clinicians and enhance public trust with patients.