What is a Safety Monitoring Board? How does it operate? When is it needed? You may have heard the term Safety Monitoring Board or one of its aliases (DSMB, DMC) and you may even have been involved in some clinical trial where a Safety Monitoring Board was used. But do you know all the bells and whistles of how to decide whether you need one for your next study, how to set it up and how to run it? Let’s take a look at the basic principles (and at some of the key details) that will put you in the right place.
What are the role and power of the Safety Monitoring Board?
A Safety Monitoring Board is expected to monitor for safety signals during a clinical study and has the power to modify or even stop the trial if such signals are detected. For this the Safety Monitoring Board must meet regularly and has access to unblinded summary data, principally safety but also efficacy data. In some cases, the Safety Monitoring Board may monitor a group of studies that are part of a development program and may need to see combined data to better evaluate the safety of the product(s) in development.
Why use a Safety Monitoring Board?
There are several reasons why one would choose to set up a Safety Monitoring Board in the framework of a clinical study. Regulations and guidance published by the main regulatory bodies (FDA and EMA) detail the circumstances where it is advisable to have a Safety Monitoring Board. These guidance also give instructions on the composition and mode of operation of a Safety Monitoring Board and we strongly advise reading them carefully before deciding. A sponsor may also choose to use a Safety Monitoring Board for internal reasons beyond those listed in the guidance. It is not forbidden; it reinforces the safety of the study and the robustness of the results, but it has a cost that should be carefully weighted against these benefits.
Who should set up the Safety Monitoring Board and who should be in it?
It is the responsibility of the study sponsor to set up the Safety Monitoring Board, contract the appropriate members and pilot the operations. These responsibilities may be delegated to a CRO or other third party provided that the appropriate contracts are signed. The members of the Safety Monitoring Board must be recognized experts in the medical field of interest, have no financial or other interest in the drug under study and commit to adhering to the rules set in the Safety Monitoring Board charter, in particular those that govern confidentiality of the study data. A chairperson is chosen by the sponsor and will have extended responsibilities, e.g. to obtain consensus whenever possible and to communicate the Safety Monitoring Board decisions after each meeting. From the Sponsor side, a coordinator is in charge of the project management aspects (preparing meetings, sending invitations, keeping minutes etc.)
How does a Safety Monitoring Board operate?
A Safety Monitoring Board operates according to a charter, written and signed before the beginning of the study, based on the protocol and with input from the study team and members of the Safety Monitoring Board. The Board typically meets at regular intervals (e.g. every six months) to review all data collected thus far, especially safety data. It is understood that the data presented to the Safety Monitoring Board are not fully verified at the time of presentation and that they may need to be unblinded to allow a comparative review. In the latter case, a “closed” meeting is scheduled without any Sponsor representatives (except a designated statistician bound by a secrecy clause). The Safety Monitoring Board will then issue a recommendation, without revealing details, to either continue with no changes, make some changes to the study or discontinue. In all cases, the recommendation is communicated to the higher management of the Sponsor and cascaded down to the development teams as appropriate. All Safety Monitoring Board decisions must be documented in the TMF for future inspections.
What is the role of a software platform in Safety Monitoring Board operations?
A Safety Monitoring Board can be operated with traditional tools such as email and spreadsheets, but as clinical studies get more complex and the different tasks are fulfilled by different groups, it becomes increasingly difficult to handle all aspects without the support of some software tool. A cloud-based platform is the best solution in this case as it allows clear and secure communication, secure storage of documents and data, transparent project management, secure access based on roles and much more. If the platform is used for several studies or for more than one committee, the cumulative advantages largely offset the cost of hiring and running the software.
In summary, DSMBs and DMCs must follow regulatory guidance. Their role is to ensure the protection of human subjects participating in clinical trials and guarantee that the clinical trial data are credible. However, Data and Safety Monitoring Boards can be challenging to manage. Adopting a validated electronic tool such as Ethical’s eDSMB® ensures compliance while simplifying the work of clinical teams and committee members.
To learn more about the eDSMB® software platform for managing Safety Monitoring Boards, reach out to Ethical.
