Ethical challenges of prospective clinical trials during the COVID-19 pandemic

ABSTRACT

Introduction

The COVID-19 pandemic has created an unprecedented opportunity to reimagine clinical research. While much has been written about the challenges associated with generating real-world evidence during the COVID-19 pandemic, comparatively little attention has been paid to the ethical challenges facing patients, clinicians, researchers, and regulatory bodies.

Areas covered

In this manuscript, we examine these challenges through the lens of informed consent and explore how the consenting process changes as our understanding of the disease is altered.

Expert opinion

We also suggest ways to limit these ethical hurdles through the use of embedded pragmatic clinical trials, which generate real-world data without the limitations associated with observational trials or the resources and lack of generalizability that are obstacles to conducting conventional randomized clinical trials. We argue that clinical research must become more nimble, and must include embedded researchers to ensure that relevant questions and ethical issues are properly addressed.

KEYWORDS:

• COVID
• pandemic
• embedded pragmatic clinical trial
• informed consent
• coronavirus

Article highlights

• The pandemic has forced biomedical research investigators to change many long-standing patient-facing research consent and collection methods to comply with COVID-19 related limitations.

• While much has been written about the regulatory and logistic hurdles associated with COVID-19 clinical trials, comparatively little attention has been paid to the ethical challenges.

• Informed consent may take on a new meaning when the standard of treatment and available data is quickly evolving.

• In order to properly address complex ethical issues associated with COVID-19 clinical trials, we believe that the clinical ressearch apparatus requires a new priority: embedded pragmatic clinical trials.

Embedded studies may enable a more nuanced discussion of informed consent and generate real-world evidence without the limitations associated with observational studies.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.