What are Data Safety Monitoring Boards (DSMB)?
DSMB, also called Data Safety Monitoring Board and Data Safety Monitoring Committee is an independent group that continuously monitors the data from various aspects of a clinical trial and guides the clinical trial group in moving forward (or stopping) with the trial.
The number of clinical trials opting for DSMB services has been increasing in the last few years. There are many reasons for that increase, such as patient safety concerns, increased awareness among the trial subjects and many more. Also, many studies sponsored by some government agencies like NIH and VA make it mandatory for the clinical trial companies to have Independent Data Safety Monitory Boards.
DSMBs are not the same as IRBs (Independent Review Boards). Though some of the responsibilities of these two bodies overlap, there are some fundamental differences between these two. Both the governing bodies are responsible for overseeing and ensuring the safety of clinical trials but IRBs are primarily responsible for the review of clinical protocols and the related documents whereas DSMBs' main responsibility is to review the trial safety and efficacy data. Cooperation between IRBs and DSMB is critical to ensure the safety of the patients and the integrity of the trial data.
It is very important for the Data Monitoring Committees to be independent of sponsor. This helps in avoiding any conflicts of interest that may arise and in increasing the credibility of the trials.
We have found that it is difficult in reality to have the DSMBs completely independent of the sponsors as most of the DMCs are selected by the sponsoring parties.
You can learn more about the DSMBs from this presentation.
This is the first blog about this topic. We will soon talk cover this topic in detail in our forthcoming posts. We would love to hear about your experiences in this area and any suggestions on any topic that you are interested in.