Katelyn Leanna Trigg

Purpose: The aim of this study is to examine documented strategies, challenges, and lessons related to clinical trial site operations during pandemics. Methods: This review focused on seven major pandemics: COVID-19, HIV/AIDS, Ebola, SARS, MERS, H1N1, and Zika. Searches were conducted using PubMed and Embase between September 2024 and February 2025, yielding 7572 unique records. After dual screening, 47 articles met inclusion criteria, with an additional 8 identified through citation searching, for a total of 55. Non-English articles were translated using Google Translate. Data were extracted and thematically analyzed through iterative familiarization, keyword identification, coding, and consensus discussion. Results: Of the 55 included articles, most originated from the European Region (61%) and the Americas (52%), with additional representation from Africa (19%), the Western Pacific (8%), Eastern Mediterranean (5%), and Southeast Asia (5%). Percentages exceed 100% because several studies reported across multiple regions. Study designs were predominantly descriptive (60%) with fewer randomized controlled trials (22%), observational (18%), and cohort studies (2%). COVID-19 accounted for the majority of articles (58%), followed by HIV/AIDS (20%), Ebola (13%), H1N1 (2%), and Zika (4%); no eligible studies addressed SARS or MERS. Operational themes included policy (73%), resources (55%), networks (53%), infrastructure (47%), technology (45%), study design (31%), and communication (22%). Publications peaked during pandemic years, reflecting intensified research activity. Reported challenges included protocol–practice misalignment, fragmented infrastructure, regulatory bottlenecks, and under-resourced sites. Reported practices included early site engagement in protocol development, streamlined ethics and contracting processes, investment in digital and decentralized infrastructure, and cross-trained staff. Gaps included limited use of adaptive trial designs and insufficient cross-national collaboration. Conclusions: Clinical trial sites implemented systemic operational changes to sustain research during pandemics. Key lessons include the need to strengthen infrastructure, workforce capacity, and institutional adaptability, and the need to address persistent global inequities. Institutionalizing early site engagement, adaptive designs, and equitable collaboration will be essential to enable timely and resilient clinical research responses in future pandemics.

Purpose: To examine documented strategies, challenges, and lessons related to clinical trial site operations during pandemics. Methods: This review focused on seven major pandemics: COVID-19, HIV/AIDS, Ebola, SARS, MERS, H1N1, and Zika. Searches were conducted using Pubmed and Embase between September 2024 and February 2025, yielding 7,572 unique records. After dual screening, 47 articles met inclusion criteria, with an additional 8 identified through citation searching, for a total of 55. Non-English articles were translated using Google Translate. Data were extracted and thematically analyzed through iterative familiarization, keyword identification, coding, and consensus discussion. Results: Of the 55 included articles, most originated from the European Region (61%) and the Americas (52%), with additional representation from Africa (19%), the Western Pacific (8%), Eastern Mediterranean (5%), and Southeast Asia (5%). Percentages exceed 100% because several studies reported across multiple regions. Study designs were predominantly descriptive (46%) and observational (30%), with fewer randomized controlled trials (22%) and cohort studies (2%). COVID-19 accounted for the majority of articles (56%), followed by HIV/AIDS (26%), Ebola (10%), H1N1 (4%), and Zika (3%); no eligible studies addressed SARS or MERS. Operational themes included policy (73%), resources (55%), networks (53%), infrastructure (47%), technology (45%), study design (31%), and communication (22%). Publications peaked during pandemic years, reflecting intensified research activity. Reported challenges included protocol–practice misalignment, fragmented infrastructure, regulatory bottlenecks, and under-resourced sites. Effective practices included early site engagement in protocol development, streamlined ethics and contracting processes, investment in digital and decentralized infrastructure, and cross-trained staff. Gaps included limited use of adaptive trial designs and insufficient cross-national collaboration. Conclusions: Clinical trial sites implemented systemic operational changes to sustain research during pandemics. Key lessons include the need to strengthen infrastructure, workforce capacity, and institutional adaptability, and the need to address persistent global inequities. Institutionalizing early site engagement, adaptive designs, and equitable collaboration will be essential to enable timely and resilient clinical research responses in future pandemics.

Objective: To summarise the literature on healthcare interventions to reduce harm to patients caused by the COVID-19 pandemic across six domains: medication safety, diagnostic safety, surgical safety, healthcare-associated infections, pressure injuries and falls. Methods: We performed a mixed-methods systematic review, with the intention to present results narratively. We combined parallel searches and expert input across each domain of interest, identifying 13 019 unique articles across the six domains. Of these, 590 full texts were assessed for eligibility. 7 were included for the medication safety domain; 7 for diagnostic safety; 32 for surgical safety; 11 for healthcare-associated infections; 5 for the pressure injuries and 2 for falls. Overall, a total of 61 unique articles were included—4 articles were represented across more than one domain. Findings: There were few rigorous evaluations of specific interventions to reduce patient harm caused by the pandemic. Adjustments in treatments, triage and procedures, and use of risk stratification tools reduced delays and permitted more elective surgery and diagnostic testing to proceed. These changes also led to improvements in medication safety practices and prevention of healthcare-associated infections. Conclusion: There has been little research on interventions to reduce patient harm caused in healthcare settings during the COVID-19 pandemic. Interventions focused on preventing nosocomial transmission of COVID-19 and on permitting access to urgent surgical and diagnostic needs. A few studies tested strategies to reduce new risks imposed by the pandemic for medication safety, healthcare-associated infections, pressure injuries and falls. Development of high-reliability health systems and healthcare organisations to protect patients and health workers from harm will be essential to mitigating the impact of future pandemics within the objectives of the Global Patient Safety Action Plan 2021–2030.

A clinical research team’s goal is to support the implementation, conduct, and monitoring of research studies and corresponding protocols. There is a need to ensure that study teams have adequate resources and regulatory support to successfully adhere to regulations and good clinical research practices. Our team, the UC Davis Division of Infectious Diseases Research Unit (IDRU), sought to establish a One Signature Initiative program for all studies and protocols supported by the IDRU. The One Signature Initiative designates one point of contact from each ancillary team or department to sign delegation and training logs, who in turn is delegated to train their team. The goals of the One Signature Initiative were, and are still, to reduce task redundancy, lessen regulatory burden on research teams, and minimize audit findings. Since the implementation of the One Signature Initiative in 2023, acceptance has been favorable, and we have expanded its footprint by incorporating it into our standard operating procedures. This article discusses our experiences, and ancillary departments’ experiences, with the One Signature Initiative. Our experience is an example of how a One Signature Initiative can be developed that is efficient, effective, and well-accepted by clinical research stakeholders.