Simple or not simple? That is the question. Clinical trials are indeed complex, but not all parts of a clinical study need to be overly complex. Some may be fairly straightforward if simple rules are followed and with the assistance of the appropriate software. DSMB (and DMC) is one of these parts that can be an island of simplicity in the ocean of clinical development complexity.
The DSMB/DMC process is not as complex as it looks
Take the DSMB process for example. It may appear complicated, and indeed it could be a lot of work if managed by hand. But with the right software platform to support the process it should not create notable difficulties to the study team. Let’s look at the DSMB process. A committee of experts is formed by the sponsor company to review periodically the study results and advise whether the study should continue unchanged, continue with changes, or be stopped. The experts must be independent, have no financial or other interest in the drug and study as they will have important responsibilities and power over the whole development pathway. They will be able to review unblinded aggregated data from the study, ask specific questions and in essence impose the conduct of the sponsor. Consequently, the DSMB process must be unambiguous, well documented, timely and well understood.
The four features that describe a good DSMB/DMC process
Unambiguous because the whole development path will depend on the committee’s decisions with potentially devastating financial repercussions on the sponsor. Unambiguous because the safety of participants to the study but also of future patients is depending on the DSMB/DMC recommendations.
Well documented. The process is described in detail in the DSMB charter which must therefore be clear and leave no shadow zones. Discussions, questions, answers and decisions must be clearly recorded and communicated to the appropriate people. Filing in the trial master file is of course required as for all essential study documents.
Timely. Usually, the DSMB meetings are planned based on study timepoints such as duration or number of enrolled subjects. The sponsor or its representatives must be ready to provide the necessary information to the DSMB at the time of the meeting to allow for timely decisions. Since safety is dependent on these decisions, no time should be lost. Ad hoc, unscheduled meetings may also occur at the request of the sponsor or the DSMB and the same requirements of timely completion apply.
Well understood. Finally, it is paramount that all parties understand the importance and the operational requirements of the DSMB process in order to act as appropriate at each step of the process. Sponsor staff, external parties (frequently used to preserve the blinding) and of course the DSMB members must understand and accept the role they are expected to play.
A well-thought DSMB/DMC software makes all the difference
Taken together, the above requirements are of high importance but do not necessarily imply a high complexity. A well-designed software like Ethical’s eDSMB® that was built from the bottom up — in other words, not repurposing existing programming that was created for other purpose —helps keep track of the process with minimal requirements for training and maintenance. Easy login process, intuitive interface, clear instructions and compliant outputs are also keys to a simple and efficient management of the DSMB/DMC process with a compliant software.
At Ethical, we are committed to offer our customers the most simple and user-friendly software solutions to allow them to handle their independent clinical committee processes in the most efficient way. Please do not hesitate to contact us should you wish to hear more about our solutions for managing DMCs, DSMBs, Adjudication Committees and other independent committees.
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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.
