CTSA Program Publications

In this paper, we address how the COVID-19 pandemic has impacted informed consent for clinical research through examining experiences within Clinical and Translation Science Award (CTSA) institutions. We begin with a brief overview of informed consent and the challenges that existed prior to COVID-19.

Introduction: The Coronavirus Disease 2019 (COVID-19) created major disruptions at academic centers and health care systems globally. Clinical and Translational Science Awards (CTSA) fund hubs supported by the National Center for Advancing Translational Sciences which provide infrastructure and leadership for clinical and translational research at many such institutions.

Over the last year, COVID-19 has emerged as a highly transmissible and lethal infection. As we address this global pandemic, its disproportionate impact on Black, Indigenous and Latinx communities has served to further magnify the health inequities in access and treatment that persist in our communities.

Introduction: The COVID-19 pandemic changed the clinical research landscape in America. The most urgent challenge has been to rapidly review protocols submitted by investigators that were designed to learn more about or intervene in COVID-19. Methods: IRB Offices developed plans to rapidly review protocols related to the COVID-19 pandemic.

Clinical trials are a fundamental tool in evaluating the safety and efficacy of new drugs, medical devices, and health system interventions. Clinical trial visits generally involve eligibility assessment, enrollment, intervention administration, data collection, and follow-up, with many of these steps performed during face-to-face visits between participants and the investigative team.

Introduction: With no approved treatments for COVID-19 initially available, the Food and Drug Administration utilized multiple preapproval pathways to provide access to investigational agents and/or medical devices: Expanded Access, Emergency Use Authorizations, and Clinical Trials.

Introduction: In March 2020 academic medical center (AMC) pharmacies were compelled to implement practice changes in response to the COVID-19 pandemic. These changes were described by survey data collected by the Clinical and Translational Science Awards (CTSA) program which were interpreted by a multi-institutional team of AMC pharmacists and physician investigators.

The 2020 COVID-19 pandemic has had a profound impact on the clinical research enterprises at the 60 Clinical and Translational Science Award (CTSA) Hubs throughout the nation.

Biospecimen repositories play a vital role in enabling investigation of biologic mechanisms, identification of disease-related biomarkers, advances in diagnostic assays, recognition of microbial evolution, and characterization of new therapeutic targets for intervention.

Rapid development and deployment of diagnostic testing for COVID-19 has been a key component of the public health response to the pandemic. Out of necessity, academic and other clinical laboratories developed laboratory testing innovations for COVID-19 to meet clinical testing demands.

Introduction

Failure to accrue participants into clinical trials incurs economic costs, wastes resources, jeop-ardizes answering research questions meaningfully, and delays translating research discoveriesinto improved health.

Introduction:

Webb et al. propose a process regarding how to prioritize allocation of COVID-19 drugs via emergency use authorization (EUA) and pre-approval access (PAA) pathways such as Expanded Access (EA) (2020). In particular, they emphasize the importance of how research (e.g. via clinical trials) intersects with the clinical availability of COVID-19 drugs (e.g. via EUA or PAA).

Here we further analyze the complexity and inherent unfairness of offering COVID-19 drugs via multiple clinical and research pathways. Using remdesivir as an example, we highlight the systemic biases that multiple pathways—both individually and as an overarching system—can engender for vulnerable patients.