Data Safety Monitoring Boards
Open/Close sub menu
Manual processes depend on the individual carrying out the tasks. Therefore, they are prone to errors and can lead to inconsistencies in output and reduced quality. Manual processes can also be difficult to track and monitor, a serious weakness 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.
Data Safety Monitoring Boards (DSMB) or Data Monitoring Committees (DMC) have become part of the clinical trial routine, adding complexity and risk to most trials. Clinical teams have the duty to support DSMB reviews by providing secure access to data while maintaining independence and confidentiality. Clinical leaders face four main challenges when managing DSMBs and DMCs: manageability and communication, security and confidentiality, GCP compliance and process governance.
Many factors affect the frequency of DSMB reviews, and ad-hoc analyses may take place at any time at the DSMB request. Planning meetings, liaising with statisticians for reports, and communicating the DSMB decisions at planned and unplanned intervals throughout a trial require rigorous procedures. Without the right tool, the risk to get off-track is real.
The data presented and the discussions taking place at a DSMB are confidential. In order to make informed recommendations, DSMB members must have access to unblinded data usually presented by an independent statistician. Without the right tool, accidental or intended disclosure is another serious risk associated to DSMB management.
DSMBs must follow GCP rules as described in the ICH E6 Good Clinical Practice Guideline. DSMBs must for example operate with written procedures (SOP) and follow a specific charter. The quality procedures in place must be strictly followed and proof must be available in the TMF. Without the right tool, GCP compliance can be challenging to achieve.
Good process governance is often a challenge, especially in long studies where personnel change and DSMB operations can be separated by long intervals. For some organizations, consistent governance across multiple DSMBs is a specific challenge. A strong, validated tool with embedded security rules has proven the best way to achieve process governance.
Setting up and conducting clinical trial committees such as DSMBs, DMCs and Steering Committees require an efficient, GCP-compliant process that guarantees safe data management, secure communication channels and meeting planning flexibility. With Ethical’s tailored, customizable and user-friendly eDSMB® software solution, clinical teams experience simplicity and efficiency in their committees day-to-day management.
On 16 February 2024, the FDA posted a draft guidance for industry entitled “Use of Data Monitoring Committees in Clinical Trials,” for public feedback until April 15th, 2024 [...]
READ MORE
Establishment and Operation of clinical trial Data Monitoring Committees and Data Safety Monitoring Boards – Helpful links to the FDA and EMA Guidance Documents.
READ MORE
A single, integrated handbook regrouping various sources of information on when, why and how to set up and use DSMBs and DMCs.
DOWNLOAD PAGE