Data and Safety Monitoring Boards (DSMBs) in clinical trials play a vital role in ensuring participant safety. However, DSMB members navigate significant challenges in the process of making informed decisions. By fostering collaboration, enhancing communication and supporting process adherence, dedicated electronic platforms play a crucial role in supporting DSMB members in their challenging responsibilities.

What is DSMB a Data and Safety Monitoring Board (DSMB)?

DSMBs are dedicated Expert Committees focusing on the safety monitoring of clinical trials to guarantee the safety of participants by advising the sponsor to continue, change or stop the study.
DSMB members have a responsibility towards the public at large, in particular towards the participants. They also have privileged access to interim aggregated study data and the obligation to observe confidentiality in order to preserve the scientific benefit of blinding. DSMBs may decide to stop a trial for any of the following reasons: efficacy (or lack thereof), harm (to participants), futility (no significant differences observed), or landscape changes (new alternatives become available).

DSMB members face numerous challenges

DSMB members face numerous challenges in managing these responsibilities effectively. Working well together is an absolute priority. Balancing patient safety and trial progress is a subtle exercise. Benefit-risk assessments are based on complex considerations. 

• Good collaboration

The first constrain for the members of a DSMB is the obligation to work together to provide the best recommendation for the study, the drug and the participants. Disagreements, delays or poor information sharing can interfere with sound judgment and affect the overall purpose of the study. Information may not always be complete, especially early in the study, and decisions may be difficult to agree upon.

• Balancing patient safety and trial progress

One of the privileges of the DSMB is the possibility to review unblinded aggregate study data at any point and to request additional information as needed to make sound decisions about the study conduct. In return, the DSMB must ensure that any recommendation given will help the development of the drug in study without risking the safety of the participants beyond reason and without exposing participants to risks beyond what is expected from the known drug safety profile and explained in the informed consent form. 

• Benefit-risk and statistical proficiency

DSMB decisions are based on extremely complex considerations of benefit-risk including absolute and relative risk, different outcomes that may describe efficacy and safety and even different populations. DSMB members must be knowledgeable about the different analysis methods allowing to overcome these difficulties including statistical methodologies and must be able to request additional analyses as needed.

Fostering collaboration and streamlining processes: the role of electronic platforms
for DSMB management

An article published earlier this year in the NEJM describes the job of the DSMB as “the toughest job in clinical trials”¹. Electronic platforms can be extremely helpful in some of the aspects of the DSMB work. They offer secure, role-based access, incorporate processes, and generate GCP-compliant records for future inspections and verifications. 

• Fostering collaboration

A secure, user-friendly interface will greatly help the DSMB members in exchanging information and opinions and will enhance collaboration with beneficial effects on the speed and accuracy of decisions.

• Enhancing communication

DSMB members can use a software platform to review data and request additional analyses from the sponsor or from the independent statistician. Quicker turnaround results in faster decisions and better control of benefit-risk.

• Supporting process and governance

Beyond the pure scientific expertise, DSMB members are expected to follow agreed processes and to make decisions in concertation with the sponsor according to previously agreed rules. Electronic platforms incorporate such rules and help all involved parties to seamlessly follow processes and apply good governance.

Ensuring success through proper implementation

Before implementing electronic tools for the management of DSMBs, one must bear in mind the following principle: A platform will never replace the scientific and medical knowledge of the DSMB members and will only work as well as it is set up. On the other hand, the best minds can be distracted or overwhelmed by poor processes or complex and contradictory operational requirements. Automation and computer support can greatly help only if set properly. It is therefore recommended to carefully consider the settings and to work with experienced providers to leverage the full power of such systems.

• Incorporating GCP rules

This is a standard obligation and probably the most common features of all systems used in clinical development. Be sure to have it in your users requirements.

• Embodying the DSMB charter

DSMB composition, frequency of meetings and decisions, data specifications, roles and responsibilities are all described in the DSMB charter. Encoding these rules in a software platform will ensure that the charter is followed at all times without the need of constant verifications.

• Preserving blinding and confidentiality

Proper roles and privileges and communication constraints set in a software platform are the guarantee that no accidental or even intended disclosure of blinded or confidential information can occur.

In conclusion, electronic platforms address some of the challenges faced by DSMB members by fostering collaboration, enhancing communication and supporting process adherence. In doing so, such platforms support sound and timely decision-making. However, proper implementation, including customization and robust security measures, is crucial for maximizing the benefits of these platforms.

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A single, integrated handbook regrouping various sources of information on when, why and how to set up and use DSMBs and DMCs.

¹ The Data and Safety Monitoring Board: The Toughest Job in Clinical Trials, NEJM Evid 2023;2(2)

https://evidence.nejm.org/doi/full/10.1056/EVIDctw2200220