Do we need another committee? If we do, how to best manage it? Would a software help or can we go with emails? These are legitimate questions every study team asks themselves at the onset of a trial as an extra committee would mean an increased workload, increased costs, and an additional challenge: preserving the experts’ valuable time. Here’s how Ethical’s eDSMB® software can help.
The proliferation of external committees in recent years has impacted both the sponsors who now have several groups to manage for every trial and most importantly the experts themselves who are solicited to participate in these committees more often than before.Considering that most experts are already very busy with their regular work taking care of patients, but also with many other tasks like publication of scientific work, participation in clinical trials as investigators and so on, they are particularly appreciative of comfortable and easy ways of working.
Managing one external expert panel with regular email communication may be feasible for both sides – although it requires the use of several software, email, text editors, PDF editors, spreadsheets etc., but when it comes to coordinating several committees (on the sponsor side) and participating in many panels (for the experts), a dedicated software can save the day.
Let’s compare the two options:
Needs and requirements:
- Quick and easy setup of the committees
- Simple and direct access for the experts who are generally very busy
- Standardized compliant processes for setup and operation
- Controlled access to blinded material
- Electronic document management (version control, signatures, archiving)
- Audit trail for inspection readiness
Pros and cons for working with email
Advantages: No need to install or learn to use another software, no additional cost.Challenges: Risk of missed communication, risk of missed deadlines, overcharged mailboxes, need to exercise strong discipline in files management and archiving, risk of accidental unblinding due to uncontrolled distribution, complex process for approval and signatures, no audit trail to support inspections.
Pros and cons for working with a software platform
All software are not equal in terms of features, but some advantages to look for are: all communications go through the same hub, the process supports seamless workflow, documents are grouped and ready for TMF archival, full audit trail supports compliance and facilitates inspections.Challenges: Data confidentiality, training, cost.
How does Ethical respond to these challenges?
At Ethical, our motivation is to support sponsors, AROS and CROs with cost-effective software solutions that save time without jeopardizing quality. We developed our range of software for clinical committees keeping in mind sponsor teams’ and experts’ busy schedules. Here’s why confidentiality, training and costs won’t be a problem with eDSMB®:
- Strict role-based access,
- Meeting templates with document authorizations,
- So easy to use that no or little training is needed,
- Simple, all-inclusive pricing model.
In summary, the increased use of expert committees has added complexity to clinical trials. A secure, efficient process supported by an easy-to-use tool such as eDSMB® for the management of DSMBs, DMCs and Steering Committees will help to guarantee the trial quality and overcome time constraints.
Role-based permissions within eDSMB® guarantee security and confidentiality
*Users with no access to the document will not receive the description message nor the file.
The use of independent expert committees has been steadily growing in clinical trials over the past twenty years. Despite stringent regulations, health authorities’ early involvement, and the sponsors’ honest intention to be as professional and objective as possible when running clinical trials, it appeared that an external eye was necessary during the design of the study and the review of the data, especially in cases where blinding was applied.
Among others, Steering Committees were created to advise on the design and help make strategic decisions during drug development, and DSMBs/DMCs to review summary data during the conduct of a study when the sponsor is not allowed to do so.
Other committees such as Adjudication Committees also get frequently called upon to help clarify clinical endpoints or safety assessments.
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.
