RE: Oxford University Prof “It is unethical not to do challenge studies”19 Nov 2020 00:24
Thanks for sharing that, Trader_3. I agree with Prof Savulescu.
In most ways, I do not find the traditional method to be ethically superior. Commonly the distinction made is that it could be unethical to deliberately make someone sick and potentially harm them, whereas a traditional trial is "natural infection", and therefore no direct harm done by researchers.
As you all know, the traditional method of testing a vaccine is that you give a proportion of volunteers treatment, and you give a proportion of volunteers placebo. Then you send the volunteers out into the wild, knowing that the infection will enter their communities at some point. The statistical threshold is met when enough infections in the placebo group occur (or treatment group, if you're unlucky); this can take a very considerable amount of time. During that period a large number of uninvolved people in the community will incidentally become infected and die while you are waiting.
I see a traditional trial as knowing a boulder will roll down the hill at some point and hit a crowd of people, but you just watch to see what happens to the treatment group vs placebo group. Conversely, our challenge trials do deliberately aim to infect volunteers, and carefully monitor them, rolling the smallest pebble at them which will cause an effect without, and without needing collateral damage in the community to see an effect.
Is the traditional approach actually ethically superior? When you consider the effects, I really don't think so.
You will need to do P3 trials still, but you can immediately get a *very* good idea of what will work and what won't, without needing to spend as long watching the disaster unfurling before your eyes or wasting time and lives on ineffective treatments.
Sure, traditional trials are ethically easier to *rationalise*, because the infections happen without the researchers' explicit actions and without any agency: they 'just' observe. Any incidents or deaths are nobody's fault, they just happened naturally out in the community. But in reality, I see that as a cop-out to avoid taking responsibility; by taking the braver step and assuming that agency via a challenge trial, it will allow earlier and more effective intervention, saving many lives that would *otherwise have been lost* during the observation phase.
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