At AmPharm Statistics, you will be able to benefit from our expertise in working with Data and Safety Monitoring Boards (DSMBs), also referred to as Data and Safety Monitoring Committees (DSMCs) or Data Monitoring Committees (DMCs). We are well versed in committee procedures, reporting, and the required statistical methodologies. Whether you are engaging our services as a Clinical Trial Sponsor, working in a research institution, or are a working DSMB, you can rest assured that we have the right solutions for your DSMBs needs.
What are DSMBs?
A Data and Safety Monitoring Board is an independent group of experts that play an advisory role to the Clinical Trial Sponsor. Some of the core responsibilities of the board include periodically evaluating and reviewing study data to determine the safety of a trial’s participants, how the studies are conducted, and how the clinical trial is progressing. In addition, DSMBs also make recommendations to the sponsor on whether they should terminate, modify, or continue a trial all while the study is ongoing.
It is not uncommon for DSMBs to define its deliberative processes in a “DSMB Charter” which includes voting procedures, committee and quorum size, unmasking methods, meeting scheduling, members (chair, secretary, statistician, physician, scientists, others), event triggers that call for an unscheduled review, trial stopping guidelines, and other activities.
How Do DSMBs Function?
DSMBs in the course of fulfilling core responsibilities will consider some or all of the following:
- Participant safety and overall risk:benefit ratio
- How external study factors may impact participant safety
- Ongoing study ethics
- Study outcomes, especially projected vs. actual
- Protocol violations, especially those related to participant safety
- Adherence to protocol requirements
- Adequacy of compliance with study products and procedures
- The performance of individual research centers
- Timeliness, completeness, and quality of data
- Evidence of efficacy
- … and other considerations
DSMBs typically conclude each review by providing their recommendations to the sponsor. These recommendations may include:
- Optional approaches for managing undesirable or unexpected study events
- Early termination or suspension of a study and/or its study arms if a preplanned futility or efficacy analysis indicates the study objectives have been met in accordance with pre-established statistical guidelines
- Early termination or suspension of studies due to inadequate enrollment rate and inability to meet study objectives
- Modifications of the study protocol to enhance participant safety
- Review and acceptance of protocol amendments, statistical analysis plan amendments, DSMB charter revisions, etc.
Why Choose AmPharm Statistics for DSMBs?
At AmPharm Statistics, we have been in the business for more than two decades and have considerable expertise with Data and Safety Monitoring Board (DSMBs) and Ethics Committees. Since our inception, we have built a diverse clientele that consists of healthcare organizations, independent research institutions, government agencies, and others.
When you work with us, you can have peace of mind knowing that we have a long-standing interest in statistical methodology and its application to public health and clinical trials. We are also passionate about discovering new ways to develop novel therapies for patients who need them the most.
If you would like to know more about our solutions for Data and Safety Monitoring Board (DSMBs) today, do not hesitate to schedule an initial consultation by sending an email to email@example.com or calling us at 844-674-3377.