In a previous article we presented an overview of the draft updated guidance on DMC that the FDA has released for comments to the public. In this article, we will discuss the changes that this new guidance brings compared to the 2006 version. Based on our own experience with DMCs, we will also explore why using a software platform for managing DMCs will help sponsors, CROs and other stakeholders comply and make better use of DMCs.
Although the use of a DMC is optional in the vast majority of clinical trials — with one exception: the absence of systematic signature of an ICF, the establishment and use of DMCs has steadily increased over the past twenty years or so, since the previous guidance was published.
The draft DMC guidance posted by the FDA begins by acknowledging this situation and by listing the main reasons for preparing an update. In short, the reasons are the following:
- DMCs are used in smaller studies than before
- DMC charters are becoming longer and more detailed
- DMCs are used in support of adaptive clinical trial designs
- DMCs oversee entire clinical development programs
- DMC functions now expand beyond the traditional use
- Drug development is getting more globalized
All of the above advocate for the use of software platforms rather than handling DMC operations with traditional tools such as email, text messages or paper. Let’s look at them in more detail and explore what has changed and how to cope with the change.
DMCs are used in smaller studies than before
DMCs were initially reserved to large trials with a big budget and complicated setup. These were relatively rare and called for exceptional dispositions. Dealing with the DMC was a sub-project of its own and sponsors could afford dedicating personnel to manage and follow up on data presentation, meeting organization and documentation. Using DMCs in smaller studies means using DMCs in more studies which multiplies the workload and increase the risk for example of accidental disclosure of confidential data. A software platform such as eDSMB® can help standardize most of the DMC operations and apply them consistently to multiple studies. DMC management, staff training and formal documentation all gain in simplicity and quality.
DMC charters are becoming longer and more detailed
DMC charters have evolved quite a lot in twenty years mainly to incorporate evolving regulations about the composition and function of the DMC but also to encompass more details on the operational side. Longer and more detailed DMC charters mean more items to manage and monitor in a formal way. Manual handling becomes increasingly resource consuming and error prone. A software platform such as eDSMB® incorporates charter provisions by design and guarantees the respect of all provisions effortlessly.
DMCs are used in support of adaptive clinical trial designs
Adaptive clinical trial designs have become much more popular in the past decades. There are very good reasons for this. Adaptive design allows to steer a study in different directions based on interim analyses and results, minimizing cost, effort and burden for participants, but it comes at a cost. That of having to perform these interim analyses in a blinded way and being ready to change the course of the study based on results. DMCs come quite handy in this setting, but their role now goes beyond the protection of participants’ safety into deciding which way the study will go. This has important repercussions on the very success of the development program and eventually huge financial implications for the sponsor. Rigorous management of the DMC operations become paramount and only a software platform can guarantee compliance with all requirements.
DMCs oversee entire clinical development programs
As experience with DMCs builds up, it becomes apparent that overseeing an entire development program with a single DMC has clear virtues. Same rules of safety and effectiveness monitoring usually apply across studies and what better way to perform the monitoring thereof than by a same group of experts applying the same rules to all studies? A software platform is clearly the best way to set up such a disposition simply, consistently and quickly. eDSMB® was specifically designed with this in mind.
DMC functions now expand beyond the traditional use
Expanding the role of DMC beyond the traditional use cab prove a complicated task if done with traditional means. Software platforms such as eDSMB® can easily incorporate new features, process all types of new information such as aggregate data and accommodate additional requirements. They are clearly the best way to accompany expansion of the DMC role.
Drug development is getting more globalized
Finally, globalization of clinical development means working in many different regions with varying legislation, in multiple languages, and sometimes different medical pactice. Monitoring and controlling all these “moving parts” is all but easy with traditional tools. Software platforms are built for that. They can effortlessly accommodate translations, time-zone differences and other specificities of global development. Check out eDSMB® and find out how it can make your global development programs easier, faster and compliant with multiple rules and regulations.
In conclusion, we believe at Ethical that the decision by the FDA to revisit the topic of DMC and revise the guidance for sponsors and other players is a wise one. Many things have changed since 2006, of which the large increase in the use of DMCs in clinical development. At the same time, software development, digital network utilization and automation have also evolved. All these taken together clearly advocate for a massive introduction of software platforms such as eDSMB® for the management of DMCs.
