Author: Sam Sun

A Tale of Two Timelines

In the midst of growing public and scientific concern regarding the integrity of clinical trials for COVID-19 vaccines, Moderna publicly released its 135-page clinical study protocol. Of biopharma companies with a COVID-19 vaccine candidate in phase 3 trials, Moderna is the first to publicly release its study protocol. The overall goal or primary endpoint of the Moderna’s phase 3 trial is to show that mRNA-1273 has a vaccine efficacy (VE) of 60% in preventing COVID-19. In biostatistics parlance, the VE is [1-HR], or 1 minus the hazard ratio. That is, the goal is to show that healthy participants who receive Moderna’s vaccine are 40% as likely to develop COVID-19, compared to participants that receive placebo. In the trial, a case of COVID-19 is defined as:

  • At least TWO of the systemic symptoms: fever (at least 100.4 degrees), chills, muscle aches, headache, sore throat, loss of taste or smell;
  • At least ONE of the respiratory symptoms: cough, shortness of breath, difficulty breathing, or pneumonia; AND, 
  • At least ONE nasopharyngeal, nasal, saliva, or respiratory test that’s positive for SARS-CoV-2

Clinical Trials, Vaccines

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Clinical Trials Accrual in a Pandemic

“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 [2].

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 [3]. 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.

Clinical Trials, Therapeutics

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The Evolution of Pandemics

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 [1].

Pandemic Preparedness, Public Health

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