Access and R&D, New England Journal of Medicine, Lancet, Science, Harvard Business Review, World Health Organization, Africa, Russia, United Kingdom, United States
development

Organisations. New England Journal of Medicine NEMJ, Lancet, Science, Harvard Business Review, World Health Organization WHO
Period. 21 - 28 May 2020

Updates on COVID-19 clinical trials

The pace of research and development for treatments and vaccines for the novel Coronavirus has intensified, with dozens of clinical trials underway around the world. Several papers were published over the weekend with preliminary findings on the two largest studies that were both stopped for different reasons.

  • In the New England Journal of Medicine, researchers reported on a randomized double-blind study for remdesivir by the U.S. CDC that was stopped prematurely due to positive preliminary results. For patients hospitalised with COVID-19, the antiretroviral appears to reduce the recovery time (by four days) and mortality (from 12% to 7%), while presenting no additional adverse events. While this is promising, the results appear to be worse for visible minorities (a group that has been disproportionately impacted by the pandemic). Researchers have also been surprised that patients treated sooner after symptom onset may not have markedly better outcomes than those treated later in the course of disease.
  • A paper in the Lancet, meanwhile, presents on the WHO Global COVID-19 Solidarity Trail on chloroquine and hydroxychloroquine. Based on the advice of the WHO Executive Group – comprised of experts from ten countries involved in the trial – the observational study was stopped as preliminary findings suggest the possibility of higher mortality rates. The WHO Chief Scientist committed to a comprehensive analysis of all emerging clinical trial data globally to consider benefit and harm, acknowledging that unlike randomized controlled trials, observational studies have been known to yield misleading results. Expertshave also critiqued the failure of the study to adequately adjust for the fact that many of the patients in the trial are more likely to be severely ill and already at increased risk of death. 

Ethics of controlled Coronavirus infection

An article in Science this week also expresses concern in the growing trend of researchers pursuing, and thousands of people expressing interest in participating in, controlled human infection (CHI) studies, i.e. deliberately exposing healthy people to COVID-19 to study infection and treatment efficacy. The authors present an ethical framework for CHIs that emphasizes “social value” as fundamental in justifying these studies. The proposed Ethical Framework for SARS-CoV-2 CHI considers six additional criteria, including: Reasonable Risk-Benefit Profile, Context-Specific Stakeholder Engagement, Suitable Site Selection, Fair Participant Selection, Robust Informed Consent, and Proportionate Payment.

Everyone in the (patent) pool

More than 100 former heads of government and leading scientists have urged all COVID-19 related research and intellectual property to be shared freely, and for the equitable distribution of vaccines. An editorial this week in Nature laments that the growing concern of “techno-protectionism” necessitates such a letter, while highlighting the remarkable speed of advancements as a result of global consortia of researchers (“Work that would normally have taken months, possibly years, is completed in weeks”). The Nature article focuses particularly on the patent pool model that is was popularized by the UNITAID Medicines Patent Pool that was successful in bringing antiretrovirals to market.

The World Health Assembly Resolution last week made explicit reference to IP rights flexibilities with respect to R&D, manufacturing and distribution of COVID-19 vaccines. Support was not unanimous, however, as some countries (notably the U.S. and the U.K) and research consortia (including the Coalition for Epidemic Preparedness Innovations) expressed their preference for conventional models where vaccine developers retain the IP rights that they may sub-license and their determined price. An article in the Harvard Business Review drew attention to the dangers of this form of ‘vaccine nationalism’, particularly as the underlying research thus far has been pooled and governments around the world have shouldered much of the risk in funding the vaccine effort.


This development is part of the digest;