“It was the best of times; It was the worst of times”
COVID-19 has forced a re-think of clinical trial design, enrollment, and execution. Among the challenges of clinical trial investigators are the ethical principles of compassionate (“off-label”) use of investigational therapies vs. randomized, placebo-controlled trials [1-2], as well as the logistical challenges of manufacture and distribution of investigational therapies .
Here, we discuss a peculiar and paradoxical challenge of clinical trials accrual in a pandemic. For any clinical trial – whether it be for cancer, Alzheimer’s disease, or diabetes – identifying and enrolling patients is a well-known challenge. For example, targeted therapies for cancers may enroll patients with rare mutations, who may be difficult to identify and to enroll onto a clinical trial at a limited number of cancer centers . It is peculiar that, as millions of patients are infected by SARS-CoV-2, that there are insufficient patients for clinical trials, whose accrual goals are typically a few hundreds of patients.
The COVID-19 pandemic has often been compared with prior infectious disease outbreaks, such as those caused by SARS, Ebola, MERS, H1N1, and the 1918 influenza virus. In the past, the spread of a virus could often be contained with public health tools alone (e.g. SARS outbreak in 2002-2004). These tools have become familiar to the public and include “containment” strategies such as testing, contact tracing, & quarantine, and “mitigation” strategies such as hand hygiene, masking, & social distancing .