Join Hafta-Ichi to Research the article “Covid trial infecting healthy volunteers needs full transparency, say campaigners | Coronavirus”
Campaigners are demanding that the full protocol of the world’s first human challenge trial in which healthy young volunteers are deliberately infected with the virus that causes Covid-19 be published before the first participants are recruited.
The trial is designed to sharpen our understanding of the virus and expedite the development of new-generation vaccines and therapeutics. While some scientists have reservations about exposing volunteers to a virus for which there is no cure, proponents argue that the risks of Covid-19 to the young and healthy are minimal and the benefits to society high.
In general, biopharmaceutical companies publish a basic one-page summary of their clinical trial protocol on databases such as clinicaltrials.gov. But detailed descriptions – including the background, rationale, objectives, design, methodology, statistical considerations and organisation of the trial, which can run into hundreds of pages – are typically withheld until after the trial is completed, in an effort to protect their competitive edge and intellectual property.
Given the scourge of the pandemic, and with some governments directly investing in vaccine trials, public health experts have pushed for publication of the detailed protocols while trials are under way. Following months of campaigning, four vaccine makers relented, publishing their full study protocols last year.
Two campaigners – Josh Morrison, the head of 1Day Sooner, an advocacy group for research participants, and Charles Weijer, a bioethicist, who disagree on whether these particular human challenge studies should be conducted – have united to demand in a British Medical Journal opinion piece that the full study protocol be made public before the first participants are recruited.
“If the pandemic has taught us anything, it’s that the public’s trust in both science and vaccines is fragile,” said Weijer, a professor at Canada’s Western University. “The last thing that I would want to see happen is an adverse event in the challenge study interfere with public confidence.”
However, according to the Dublin-based company Open Orphan, which is conducting the study in partnership with Imperial College London, the characterisation study portion of the challenge trial designed to establish the minimum dose of the virus required to cause Covid has already begun.
Weijer said it would be useful to see precisely how these escalating virus doses would be administered and the exact procedures that would be used to monitor adverse events. He has publicly described this human challenge study design as “fundamentally unworkable” given the potentially serious risks associated with Covid infection, including long-term disability among young adults.
Dr Chris Chiu, of Imperial College, the chief investigator of the human challenge study, said he understood the significance of publishing the full protocol, suggesting it should be done “whenever possible”.
“I think it’s generally a good idea, but it doesn’t have to be done prior to a study starting. In our case, the protocol has been designed by a large consortium of experts and undergone extensive peer and ethical review. Once approved it was the study team’s priority to implement the study as designed, which is urgent during this pandemic,” he said.
The plan is to eventually publish the full protocol, he added. “We have yet to decide if this will be as a separate publication or as an appendix to the first paper from the study. In the meantime, the clinicaltrials.gov study summary is in preparation and will be up in the coming days. This is publicly accessible and provides all the key details.”
In general, publishing protocols later gives investigators the opportunity to change the outcome measures before the publication of results and to cherrypick data, suggested Weijer and Morrison.
“I don’t think that it’s unfair for people to criticise the idea of … this specific challenge study,” said Morrison, who has campaigned in favour of human challenge trials. “But I do think it’s better that these criticisms can be informed by the details of what’s actually happening.”
Source: The Guardian
Keyword: Covid trial infecting healthy volunteers needs full transparency, say campaigners | Coronavirus