Data Safety Monitoring during Covid‐19: Keep On Keeping On

Barnbaum, Deborah R.

doi:10.1002/eahr.500053

Cited by 3 publications

(6 citation statements)

References 2 publications

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“…As the pandemic ends, robust visits and monitoring should return to the pre-pandemic processes. We acknowledge that the COVID-19 pandemic will most likely introduce protocol deviations; these deviations should be managed according to standard procedures in a manner that is in the best interest of the participants without exposing them to unnecessary risks ( 35 ).…”

Section: Institutional Review Board and Ethical Approvalmentioning

confidence: 99%

“…Patient folders should contain completed informed consent forms, screening sheets clarifying inclusion and exclusion criteria, patient CRFs, laboratory values, and a record of all communication with the subject. Data safety monitoring boards with relevant clinical expertise, completely independent of the investigators, should be available to evaluate interim data to ensure that participants are not exposed to additional risks ( 35 ). During the COVID-19 pandemic, participants have been hesitant of going to hospitals.…”

Section: Data Analysis and Integritymentioning

confidence: 99%

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Obstacles and Considerations Related to Clinical Trial Research During the COVID-19 Pandemic

et al. 2020

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The response to the COVID-19 pandemic from the research and science community has been vigorous, with information being released faster than that of any other event in human history. Articles related to the virus were being rapidly published by January 2020. A small fraction of these publications comprised reports of prospective clinical trials (0.25%), and many of these trials have imparted conflicting conclusions, leading to confusion among the public and the scientific community. Additionally, the pandemic has raised many serious scientific and ethical concerns related to clinical research. In this review, we divided the conduct of clinical research trials into three steps and critically reviewed each step, along with the challenges and obstacles arising amid the ongoing crisis. The clinical research steps we reviewed include (1) clinical trial design factors such as social and scientific value, feasibility, single vs. multicenter trials, randomization, control groups, endpoints, off-label and compassionate use of medications, data analysis, and verifying the integrity of data; (2) ethical issues such as committee approvals, efficiency, virtual visits and remote monitoring, informed consent, shipping investigational products, and external monitoring and audits; and (3) publication and sharing of preprints, press releases, social media, and misinformation. The COVID-19 pandemic is adversely affecting existing clinical trials for other ailments and diseases, including cancer, with most trials being delayed or deferred. Although urgency is needed to communicate effective treatment and prevention strategies for COVID-19, research efforts should maintain the same high-quality core ethical principles that governed human subject research before the pandemic. Despite the catastrophic devastation caused by the pandemic, the adoption of more flexible, cost-effective methods of conducting clinical trials (without compromising ethical conduct, safety, or data integrity, while maintaining research efficiency) represents a potential silver lining. Streamlining clinical research will help to congruently address other important health issues, despite the ongoing COVID-19 crisis.

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Section: Institutional Review Board and Ethical Approvalmentioning

confidence: 99%

Section: Data Analysis and Integritymentioning

confidence: 99%

Obstacles and Considerations Related to Clinical Trial Research During the COVID-19 Pandemic

et al. 2020

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“…Data and Safety Monitoring Boards (DSMBs) are charged with ensuring the safety of clinical trial participants and the validity and integrity of trial data [1]. The outbreak of the novel coronavirus SARS-CoV-2 pathogen, known as the COVID-19 pandemic, posed unique challenges to DSMBs overseeing studies of a disease not well characterized and treatments never tested in context [2]. In addition, by the summer of 2020 as the rate of COVID-19 related deaths in the United States surpassed 125,000 [3], the extended timeline to disseminate trial results to practitioners was a delay that investigators and the public could not afford.…”

Section: Introductionmentioning

confidence: 99%

“…As an increasing array of data became available, DSMBs remained naïve to the information in larger, informative trials. In the absence of information, there is known potential for individual study data to produce an inaccurate signal for efficacy, futility, or harm, thereby increasing the risk of premature trial discontinuation [2,4,5]. Research indicates that the early termination rates for randomized control trials are between 10% and 12% [6,7].…”

Section: Introductionmentioning

confidence: 99%

“…The FDA 2021 guidance for safety reporting notes the requirement for an aggregated analysis has the benefit to allow sponsors (and by extension DSMBs) to meaningfully interpret safety signals of investigational therapeutics [12]. Research suggests DSMBs should exercise patience when a small study shows positive or negative signal, especially if the signal from multiple studies is discordant [2,4]. Conversely, DSMB confidence in reviewing stopping rules for a specific study can be enhanced by understanding there is directional concordance with other studies in the same therapeutic area [2,4].…”

Section: Introductionmentioning

confidence: 99%

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Securely Sharing DSMB Reports to Speed Decision Making from Multiple, Concurrent, Independent Studies of Similar Treatments in COVID-19

Dilts

Harrell

Lindsell

et al. 2022

J. Clin. Trans. Sci.

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Introduction: As clinical trials were rapidly initiated in response to the COVID-19 pandemic, Data and Safety Monitoring Boards (DSMBs) faced unique challenges overseeing trials of therapies never tested in a disease not yet characterized. Traditionally, individual DSMBs do not interact or have the benefit of seeing data from other accruing trials for an aggregated analysis to meaningfully interpret safety signals of similar therapeutics. In response, we developed a compliant DSMB Coordination (DSMBc) framework to allow the DSMB from one study investigating the use of SARS-CoV-2 convalescent plasma to treat COVID-19 to review data from similar ongoing studies for the purpose of safety monitoring. Methods: The DSMBc process included engagement of DSMB chairs and board members, execution of contractual agreements, secure data acquisition, generation of harmonized reports utilizing statistical graphics, and secure report sharing with DSMB members. Detailed process maps, a secure portal for managing DSMB reports, and templates for data sharing and confidentiality agreements were developed. Results: Four trials participated. Data from one trial were successfully harmonized with that of an ongoing trial. Harmonized reports allowing for visualization and drill down into the data were presented to the ongoing trial's DSMB. While DSMB deliberations are confidential, the Chair confirmed successful review of the harmonized report. Conclusion: It is feasible to coordinate DSMB reviews of multiple independent studies of a similar therapeutic in similar patient cohorts. The materials presented mitigate challenges to DSMBc and will help expand these initiatives so DSMBs may make more informed decisions with all available information.

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The Surviving Sepsis Campaign: Research Priorities for Coronavirus Disease 2019 in Critical Illness

Coopersmith

Antonelli

Bauer

et al. 2021

Critical Care Medicine

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OBJECTIVES: To identify research priorities in the management, pathophysiology, and host response of coronavirus disease 2019 in critically ill patients. DESIGN: The Surviving Sepsis Research Committee, a multiprofessional group of 17 international experts representing the European Society of Intensive Care Medicine and Society of Critical Care Medicine, was virtually convened during the coronavirus disease 2019 pandemic. The committee iteratively developed the recommendations and subsequent document. METHODS: Each committee member submitted a list of what they believed were the most important priorities for coronavirus disease 2019 research. The entire committee voted on 58 submitted questions to determine top priorities for coronavirus disease 2019 research. RESULTS: The Surviving Sepsis Research Committee provides 13 priorities for coronavirus disease 2019. Of these, the top six priorities were identified and include the following questions: 1) Should the approach to ventilator management differ from the standard approach in patients with acute hypoxic respiratory failure?, 2) Can the host response be modulated for therapeutic benefit?, 3) What specific cells are directly targeted by severe acute respiratory syndrome coronavirus 2, and how do these cells respond?, 4) Can early data be used to predict outcomes of coronavirus disease 2019 and, by extension, to guide therapies?, 5) What is the role of prone positioning and noninvasive ventilation in nonventilated patients with coronavirus disease?, and 6) Which interventions are best to use for viral load modulation and when should they be given? CONCLUSIONS: Although knowledge of both biology and treatment has increased exponentially in the first year of the coronavirus disease 2019 pandemic, significant knowledge gaps remain. The research priorities identified represent a roadmap for investigation in coronavirus disease 2019.

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Data Safety Monitoring during Covid‐19: Keep On Keeping On

Cited by 3 publications

References 2 publications

Obstacles and Considerations Related to Clinical Trial Research During the COVID-19 Pandemic

Obstacles and Considerations Related to Clinical Trial Research During the COVID-19 Pandemic

Securely Sharing DSMB Reports to Speed Decision Making from Multiple, Concurrent, Independent Studies of Similar Treatments in COVID-19

The Surviving Sepsis Campaign: Research Priorities for Coronavirus Disease 2019 in Critical Illness

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