DSMB

Top 4 Challenges in Data Monitoring Committee Management 

Managing DMCs doesn't have to be complicated.

When investigating a new drug, device, or procedure, clinical trials encounter risks to participant safety and well-being and data validity and integrity. A Data Monitoring Committee (DMC), also known as a Data and Safety Monitoring Board (DSMB), is a powerful mechanism to manage these risks.

PSI defines a DMC as:

  • A multidisciplinary group set up by the study sponsor
  • Comprised of individuals with expertise in the specific indication of a clinical trial
  • Charged with regular review of clinical study data to monitor a clinical study’s safety and/or efficacy parameters.

A DMC should be independent of the sponsor and the clinical trial’s conduct. DMCs play a unique role in ensuring the safety of human subjects enrolled in clinical studies. During the past 30 years, the use of DMCs increased significantly – from 210% of trials reported in high-impact journals in 1990 to 25% in 2000 and 35% of industry-sponsored clinical trials in 2007-2010.1,2 The use and role of DMCs have also evolved, and their management has become more challenging and complicated. Among these challenges, four are particularly important for the DMC’s functioning and, in turn, the whole investigational program.

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 perform a review of 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.

Challenge #3: Preparation of a DMC Charter

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.

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.

Summary

Under the expert leadership of Maxim Kosov, MD, PhD, Senior Medical Advisor, PSI will assist with establishing and administrating the DMC as part of our full-service management of your pivotal study.

For more information, download our white paper How to Use Data & Safety Monitoring Boards: From Planning to Execution.

Services

  • Identification of DMC members 
  • Development of DMC charter 
  • Generation of statistical outputs and their distribution to the DMC members 
  • Administrative oversight at all stages of the DMC set-up and functioning 
  • Scheduling and organization of DMC meetings  
  • Preparation, finalization, and archiving of DMC meeting minutes 
  • Filing of all DMC-related documentation and correspondence in the Trial Master File
  • Managing payments to DMC members 

The PSI Difference in DMC Establishment and Management  

20+ years of experience in managing all types of data and safety monitoring committees. 

  • Specially dedicated independent DMC Support Group provides all organizational and logistical support to DMCs. 
  • Strong team of biostatisticians who are highly experienced in DMC statistical support. 
  • Proprietary database of potential DMC members consisting of 800+ experts from different therapeutic areas.  

1 Fleming TR, DeMets DL, Roe MT, et al. Data monitoring committees: promoting best practices to address emerging challenges. Clin Trials 2017; 14:115–23.doi:10.1177/1740774516688915

2 Califf R, Zarin D, Kramer J. et al. Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010. JAMA, 2012; 307 (17): 1838-1847.

3 Use of data monitoring committees in clinical trials. Guidance for industry. February 2024.

About Us

For 25 years, we have built trusted relationships with biotech sponsors, with 90% of our customers being repeat and referral. 

Case Study

Antibiotic development is notoriously underfunded, but PSI meets enrollment rates 23% higher than the industry average. See how PSI supported this sponsor by leveraging site relationships for the most pragmatic site selection.

Global Reach

Clinical trial sponsors working in oncology, hematology, IBD, infectious diseases, multiple sclerosis, and many rare diseases rely on PSI’s guidance and experience. 

Top 4 Challenges in Data Monitoring Committee Management  Read More »

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Using Data & Safety Monitoring Boards: From Planning to Execution

Is a DSMB right for your study?

The randomized clinical trial (RCT) is the gold standard for evaluating the benefits and harms of new medical interventions. Safety surveillance is one of the core objectives of every RCT, and one such body is a Data and Safety Monitoring Board (DSMB) – also known as a Data Monitoring Committee (DMC). 

A DSMB is an independent group of individuals with relevant expertise external to the study sponsor, charged with a periodic review of clinical trial conduct, efficacy, and participant safety and recommending trial continuation, changes, or termination when appropriate. However, the role of DSMBs has evolved since their initial creation, making their management more challenging and complicated. 

Read our new white paper to learn about: 

  • How the role of the DSMB has evolved in recent years and current challenges in DSMB management 
  • When a DSMB is needed  
  • The primary considerations for committees to maintain eligibility, credibility, and high-quality outcomes 

About Us

For 25 years, we have built trusted relationships with biotech sponsors, with 90% of our customers being repeat and referral. 

Case Study

Antibiotic development is notoriously underfunded, but PSI meets enrollment rates 23% higher than the industry average. See how PSI supported this sponsor by leveraging site relationships for the most pragmatic site selection.

Global Reach

Clinical trial sponsors working in oncology, hematology, IBD, infectious diseases, multiple sclerosis, and many rare diseases rely on PSI’s guidance and experience. 

Using Data & Safety Monitoring Boards: From Planning to Execution Read More »