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The OP was critiquing the media reporting on the study not the study itself so I think your suggestion that the OP misunderstood the point of the study is off base.

The OP did not claim that the study sought to answer the questions posed. The article does answer the question 'Is it safe?' with the word 'Yes' so I believe you are actually in agreement with the OP and the OP did understand that it is really early to say that, hence the critique.

> Although this virus has killed many, the risk factor for it is nowhere near high enough to warrant an emergency vaccine.

Sure reads to me like the OP is attacking the idea of developing a vaccine, not the media coverage.

To me, it seems like OP is attacking the idea of releasing the vaccine to the general public without due diligence. That’s different than developing it.

It is slightly different than a regular Phase 1 study because there's a control arm. I suspect they want to use the data as a complement to the Phase 2/3 results in the unfortunate case the volounteers end up positive for the virus.

It's still good to see such questions being raised in the community, especially when someone knowledgeable on the matter (such as yourself) has an educated response.

Thank you for participating and for sharing these details!

> (Disclaimer - I'm a participant in the UK Phase 2/3 trial)

I have always thought those medical trials are conducted under an NDA against the patient, meaning you do not only not know what group you are in, you are not even allowed to tell you are being observed in such a study (to prevent accidental unblinding).

There is no NDA in this trial. For the control, they used an unrelated approved vaccine with very similar expected side effects to prevent accidental unblinding.

The one thing we agreed to do was not to get an antibody test as that would unblind ourselves.

How would you expect to obtain informed consent without the patient knowing they're in the study?

Being in a trial does not guarantee you get the investigative candidate because many trials have control arms without an intervention (hence a double-blind randomised controlled trial). Neither you or the doctor know which arm you are in during a double-blinded trial because placebo effects are very well known and have to be accounted for during the drug development process. This very much depends on the study design and phase of the study. Informed consent will take a patient through these factors, but it does not mean they are guaranteed to get the intervention. There are studies which have been stopped before the trial hit its end-points as it was deemed unethical not to give patients in the control arm the intervention because it proved so effective.

Nothing indicates that the commenter knows if he's in the placebo group or the real thing group. He just said he is participating in the study, that could mean he's in either group.

The thing is someone else participating in that same study may read that and experience an unintended placebo/nocebo/antidote effect. You are not supposed to dicslose you are in such a clinical trial. The ancestrals misunderstood that as not telling the test subject that he is being tested. You could also neutralise that consent effect by making the group of consent broader than the group of study, by adding two more controls such that one group (reverse intervention group) takes a drug that acually worsens the disease (I see the possible objections, but this alone will make the study complete faster), and one takes just nothing (neutral group-those would be sent back by telling them they are diagnosed negative, but actual diagnosis will be recorded in their files), in addition to a placebo group.

> You are not supposed to dicslose you are in such a clinical trial.

They never asked that or made us sign anything to that effect.

In this Phase 3 trial, they are measuring prevention of disease across ~10,000 people. They just want to see who tests positive for COVID and how sick they get. In this Phase, they aren't asking most groups about side effects or any subjective questions about symptom severity or anything like that where reading that someone was in a study would influence our opinion.