Top 4 Challenges

Challenge #1: Defining the need for a DMC

While there are no strict criteria for when a DMC is required, and the decision to establish a DMC in the clinical trial is ultimately the decision of the study sponsor, there is a consensus that a DMC is practical for long-term clinical studies when there is limited experience in a therapeutic area or when participants are from a vulnerable population.

The FDA strongly recommends establishing a DMC if trial subjects are at risk of serious morbidity or mortality.³

PSI Solution:

PSI’s approach is that sponsors should evaluate the use of a DMC regardless of study size or study phase. When determining whether to recommend a DMC, we analyze the potential for a high overall study risk, the intervention's complexity, and the study population’s vulnerability.

Challenge #2: DMC Composition

Selection of the right DMC members is a critical part of DMC management.

A poorly constituted DMC may have little credibility, while a strong committee can review the highest quality and scientific merit. To select and appoint the right DMC members, one must address such questions as the number of the members, their qualifications and experience with clinical trials and DMCs, geographical location, and independence from conflicts of interest.

PSI Solution:

PSI has established a process of DMC member selection with a clear distribution of responsibilities and form templates. This process is formalized in a Standard Operating Procedure (SOP) and a Business Process Description (BPD). We have also created a database of potential DMC members (including independent biostatisticians), comprised of over 800 experts in various therapeutic areas, that can be matched to any particular study.

The DMC Charter is a guiding document for the DMC functioning that includes well-defined standard operating procedures.³

A well-developed charter allows for structured consideration of critical concepts, improves effectiveness, and bolsters trial integrity.

Challenge #3: Preparation of
a DMC Charter

PSI Solution:

The best practice is to use a standard template modified for the individual study.

PSI has developed a DMC Charter template widely used in all clinical trials where PSI is contracted for DMC management.

Challenge #4: Meeting organization

Organization of DMC meetings involves scheduling the meetings; preparation and distribution of statistical outputs and other data required for the DMC review and specified in the DMC Charter; preparation of the meeting agenda; preparation, review, finalization, approval, and filing of the DMC meeting minutes and recommendations; and follow-up actions to the meeting.

PSI Solution:

Each of these activities requires well-orchestrated efforts from the team members and should ideally be performed by professionals skilled in such tasks.

PSI has established a DMC Support Group, which includes DMC Coordinators who are not involved in any other study-related activities but provide all necessary support to the DMC to which they are assigned.