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Importance of Safety Oversight in Clinical Trials 

December 2022

Importance of Safety Oversight in Clinical Trials

Description automatically generatedClinical trials are vital to the scientific process as the backbone for verifying novel therapeutic approaches to a variety of health conditions in medicine, pharmaceuticals, and research. It is important to maximize clinical trial success and provide effective, valid, and reliable results, as study populations tend to be vulnerable, and therapies are needed to treat society at large. Regulatory Safety Oversight – the practice of enlisting an independent panel of experts to actively review safety data – is crucial to achieving this goal, and, as of the 1960s, is a consistent practice in clinical trials conducted in the United States (U.S.).

Established Safety Oversight is important in achieving clinical trial success by upholding high standards of patient safety, reducing wasted time in clinical trial progression, decreasing overall cost of clinical trials, and optimizing results.4 Safety Oversight panels provide expert review of safety data, to ensure the study is safe and effective, and verify the data is reliable. Quality of clinical trial conduct is directly linked to clinical trial outcomes – a greater emphasis on Safety Oversight measures in a clinical trial leads to results that are favorable and reproducible.2  Study participant safety and trial integrity is a responsibility for all those involved in clinical trial administration and is upheld by Safety Oversight panels.6 The positive impact of the expert panel is seen in recent studies exploring clinical trial design, which recommend the use of designated Safety Oversight, and in the continued use of these boards for both sponsored and independent clinical research.1 Safety Oversight measures are commonplace in modern clinical trials, and a requirement in many Federally-funded trials in the U.S.

Historically, integration of Safety Oversight in clinical trials began at the Federal level in the 1960s. At the time, a handful of large-scale, Federally-sponsored trials conducted by the National Institutes of Health (NIH) and the Department of Veterans Affairs (VA) in the U.S. focused on eliciting data from study populations at multiple sites – it became necessary to establish a board to review and discuss data as individual site visits were not feasible to conduct at timely intervals. This early solution to a then-novel issue evolved into practice and regulatory guidelines as the panel of experts, known as the Data Monitoring Committee (DMC), provided significant insight and improved study outcomes. DMC members have subject expertise that allows them to provide feedback in protocol development and design, study progress, and safety data. These committees ensure trial validity and reliability, but most importantly, patient safety. The immense contribution of this panel of experts was irrefutable, and U.S. Federal organizations began exploring the use of DMCs in clinical trials.

DMCs oversee modern day clinical trials and provide Safety Oversight at many levels and scopes. Safety Monitoring Committees (SMCs) oversee early Phase I and Phase II single-site studies. Data and Safety Monitoring Boards (DSMBs) must include a Biostatistician, and oversee Phase II and Phase III multi-site studies and review efficacy data for the duration of the trial. For both DSMBs and SMCs, patient safety is paramount in their analysis of the clinical trial and their recommendations to the Principal Investigators (PIs) and Institutional Review Boards (IRBs).

The impact of these panels of experts is significant, such that research conducted globally follows this format.3 To streamline findings from other foreign organizations and to conduct continuing studies in other nations, DMCs work closely with clinical teams following Institutional Review Board (IRB) approval as part of Good Clinical Practice (GCP).8 Overall, the presence of a DMC in a clinical trial is functional and effective, and participants in clinical trials themselves support the notion of Safety Oversight in the conduct of clinical trials.5 Qualified members are recruited to enroll for DMCs through a strict vetting process – clinical expertise and domain knowledge are accounted for and potential Conflicts of Interest (COIs) in personal, professional, financial areas are evaluated. This initial process is essential to ensure the panel of experts is independent of the clinical team and sponsors, and potential bias must be ruled out by evaluating and reconciling possible affiliations. Each DMC member is required to review and sign the Committee Charter and to confirm ongoing protection and confidentiality of trial data. Additionally, each member on the panel understands the impact of each clinical trial and the scope of safety data, potential Significant Adverse Events (SAEs), and reliability/validity metrics. TRI has extensive experience in this process within Safety Oversight, and actively reaches out to subject area experts and prior DMC members for their continued service.

Safety Oversight - Topic Checklist

Safety Oversight panels are integral to study progress. During the trial, if SAEs are reported or trends identified during data review that require a study halt, the committee, in conjunction with the Medical Monitor, will recommend changes to the sponsor, to ensure patient safety prior to restarting study.7 This process was demonstrated during the recent COVID-19 pandemic, when clinical trials were halted briefly based on patient safety data. Safety Oversight of clinical trials begins before the enrollment of participants and ends following the accrual and maturation of results for each participant. The TRI team facilitates the Safety Oversight of clinical trials throughout their lifespans by recruiting and evaluating potential DMC members, coordinating the generation and transmittance of safety reports, facilitating the Safety Oversight panel reviews of safety data, and maintaining study records.

Safety Oversight is recommended in Good Clinical Practice, as studies are often conducted across multiple regions, including internationally. It is often prohibitive for DMC members to travel to each study site and conduct review of safety data, yet their expertise is crucial to evaluating ongoing updates during clinical trials.3 Additional factors may bar travel and visits to clinical study sites, such as the danger of exposure to SARS-CoV-2 coronavirus disease 2019 during the recent COVID-19 pandemic. TRI provides supportive services to ensure DMC members receive safety data generated by all study sites in a timely manner, such that the DMC can actively review and assess the clinical trial. DMCs are integral to necessary Safety Oversight by advising clinical teams to evaluate the safety data and guide clinical trial process in the event of unexpected outcomes. The sheer expertise of the panel reduces time wasted in clinical trials – clinical teams receive recommendations to improve study design for patient safety instead of researching for alternative solutions in the case of unexpected trial outcomes.

Technical Resources International, Inc. (TRI) is a Contract Research Organization (CRO) with extensive experience in supporting Safety Oversight for clinical trials. TRI is an industry expert in clinical research working closely with Federal organizations and provides a wide range of support services for clinical research and clinical trials. We maintain a network of subject experts in infectious diseases, cancers, safety data, and additional clinical specialties to establish panels monitoring clinical trial progress. To date, TRI has supported hundreds of clinical trials at multiple study locations.

About the Author

Tayyab M. Ahmad, MS is a graduate of Georgetown University where he studied Integrative Medicine. Currently, he supports Safety Oversight processes and is assigned to federal, local, and internal projects. With significant exposure and experience to medicine in practice, research, and clinical research, Tayyab combines knowledge and skills to contribute to TRI his local community, where he has founded and runs a clinic providing cost-free care to the underserved, underinsured, and unhoused. 


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