Accidental disclosure of unblinded data is a serious risk that can jeopardize the validity of the entire study if the DSMB process is not “airtight”. In this blogpost, we will explore the limits of manual process for DSMBs in terms of data security and team performance. In contrast, it will become apparent that the benefits of a validated software for DSMB management are substantial.
Double-blind randomized clinical trials are the cornerstone of modern clinical development and have proven their utility times and again in various settings (active treatment versus placebo, new compound versus established treatment and so on). Blinding of patients, investigators and sponsor staffs is essential to the unbiased comparison and is usually ensured by multiple mechanisms (randomization codes kept hidden, independent IVRS for assigning subjects to treatment arms, identical drug formulation, etc.). There are circumstances, however, when blinding must be lifted at least for a restricted group such as a DSMB.The DSMB unblinding risk
Unblinding is performed in order to monitor the safety and identify signals that can indicate unnecessary exposure of subjects to undue risks. For example, it may become apparent upon interim review of the data that a drug is causing too many adverse events, or that it is not effective enough to warrant the risks. By reviewing unblinded aggregate data, a DSMB can identify such risks and recommend appropriate action. However, if the DSMB process is not “airtight”, blinded data can accidentally be disclosed to the wrong audience and jeopardize the validity of the study. Such risk is the nightmare of every sponsor company.
The benefits of a validated software process
The stress on a team associated to a complex process (see box below) can be avoided if a software platform incorporating a secure procedure is used. By eliminating manual errors and inconsistencies, a strong software process can help reduce variability and thus ensure that output is of a high quality. Furthermore, a validated software process can provide robust documentation and traceability and meet regulatory requirements. Lastly, the use of a validated software can help standardize process across an organization when needed, promoting consistency, harmonization, and efficiency.
Security of a software platform for DSMB management
On the other hand, the use of yet another software can also be source of stress for the study team, require additional training and incur additional cost. So, in the end, is the use of a software platform the right solution to avoid the risk and reduce stress for the study team?
To answer this question, one needs to consider the software characteristics. Embedded security rules with robust authentication, data encryption — in transit and at rest — and role-based permissions should altogether guarantee the system security. In addition, if the security rules are transparent to both internal (sponsor) and external (DSMB members) users and if it is simple to use with a user-friendly interface, then the benefits will clearly overcome any burden or cost.
In conclusion, the peace of mind provided to study teams but also to upper management by a robust process supported by a solid platform such as eDSMB® have a high value and will be recognized by all as a serious advantage over manual procedures that carry serious risks for the company, the staff and the DSMB members.
What is an “airtight” process? Certainly not a process handled manually.
Because they depend on the individual carrying out the tasks, manual processes are prone to errors and can lead to inconsistencies in output and reduced quality. Furthermore, manual processes can be difficult to track and monitor, which is an important drawback in the DSMB context where all decisions must be documented. In the complex and highly regulated environment of clinical trials where errors can have serious consequences, manual processes can only add stress on a team, potentially leading to impaired dynamics and performance. The effects of stress on a team range from decreased productivity and creativity to increased conflicts, poor morale, and increased absenteeism. For example, when team members are stressed, they may find it harder to focus, work efficiently and meet deadlines. When stress levels rise, communication can become strained, and misunderstandings can occur, leading to more disagreements and tension.
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