The use of external independent panels of experts for the interim review of study data reinforces the quality and reliability of the data, ensures the protection of participants from unnecessary exposure to investigational products, and helps sponsors take informed decisions on the conduct of the study. All good reasons for including a DSMB even if it is not formally requested by Health Authorities (HA). However, the management of these committees also brings its load of issues unless you choose to streamline the process using a dedicated software. Definitely a good idea to consider if you’re planning a new study.
Setting up a DSMB has become almost a reflex in recent year for all blinded clinical studies, especially when testing new treatments that may cause adverse reactions, when active treatments are compared to placebo or when the study lasts for a long time.Using a DSMB increases patient safety and can even speed up market access
Indeed, the ability to perform interim reviews of the data without breaking the blinding helps minimize the exposure of participants to unnecessary risks (from exposure to potential adverse effects of from keeping them on placebo treatment), allows sponsors to save time and resources by potentially interrupting a study earlier and can even help speed up the access to market to the greater benefit of all, sponsors, physicians and patients. Health authorities increasingly request the presence of a DSMB and most sponsor companies have become familiar with the principle over the years.A DSMB means more tasks and an additional panel of experts to manage
Popularity, however, brings its own issues. More work for the statisticians and data managers, additional clean-up operations to produce clean data for the interim reviews, additional blinding procedures to avoid accidental disclosure of the data to the blinded parties. Sometimes an external statistician needs to be hired to preserve the blinding of the data. Most importantly, external experts are being solicited ever more frequently to participate in these committees. While most experts are happy to be part of the early review of experimental data, these additional assignments put stress to their already busy schedule. Unless the process of interim study data review is well set and really seamless, frustration can quickly build up.A good DSMB software can help streamline the committee management process
Here is how a good software like eDSMB® can help streamline the DSMB process and keep all parties happy. Compliance, user friendliness and efficiency are perhaps the top three reasons why a clinical team should consider such a software:1. Compliance: all documents, recording, activities related to the DSMB are stored in a single repository without the need for extra effort from the study team.
2. User-friendliness: support in meeting definition, quorum, signature, collection of documents.
3. Efficiency: time spent on DSMB-related activities is reduced, the clinical trial team and committee members have more time to focus on what matters most.
In summary, a good software like eDSMB® can help everyone involved in the DSMB process, particularly the external experts, by ensuring a flawless process with minimal burden for efficient interim data review, ultimately protecting patients who agree to participate in clinical trials.
DOWNLOAD NOW THE FREE DATA SAFETY MONITORING HANDBOOK
A single, integrated handbook regrouping various sources of information on when, why and how to set up and use DSMBs and DMCs.
