> people can't "fake" clinical trial results like this to sell medication
Many clinical trials are controversial when they are positive.
Most clinical trials are subcontracted. The subcontractor has a deep interest in pleasing his client. You can select patients at the beginning of the trial, or during the trial you can report that a patient with a "bad" result, just dropped out of the study. And indeed in most clinical trials there is no strong adverse effects (just weak) reported except when patients die.
Moreover, the hospitals that implement the trial often only do the minimum to satisfy the principal investigator
Just look at the field of neurodegenerative diseases or ask patients how negligently they have been treated.
It is fine to be sceptical, but I think you should have taken a few minutes to read the method chapter in the study, seeing as that possibly could have eased your doubts. The first sentence cites the previously published design of the study. In the method chapter it is reported to be an "international, double-blind, randomized, placebo-controlled trial" with 3533 participants and a mean median follow-up of 3.4 years[0]. The cited article on the study of the trial states that "Participants were enrolled from 418 trial locations across 28 countries." [1]
> Many clinical trials are controversial when they are positive.
Which isn't the same as being "faked".
> Most clinical trials are subcontracted.
They are not subcontracted, clinical trial sites are identified. They are basically doctors interested in running a trial. Usually done at academic hospitals.
> The subcontractor has a deep interest in pleasing his client.
No they don't. They have no vested interest beyond their own careers and publications. Doctors only put a few hours into a clinical trial each month, usually their own patients. Most of the work is done by clinical trial staff. The costs of the trials are paid for by the sponsor, but that money doesn't go into the doctor's pocket, it's the hospital.
> You can select patients at the beginning of the trial, or during the trial you can report that a patient with a "bad" result, just dropped out of the study.
But pretty much every trial is triple blinded. The company, doctor and patient don't know if the patient got the drug or the placebo. Placebos are chosen to pretty much be identical to the drug (people get injections, take pills that look exactly the same).
And no, you can't just "say a patient dropped out". There is a predefined set of criteria that the doctor needs to follow. The patient needs to agree to follow them as well. But again, the doctor doesn't know who received what so how they can they "tweak" the results?
Plus if a patient drops out, the results are penalized. The data doesn't just disappear. All data needs to be reported to the FDA for every patient, including all follow ups.
> And indeed in most clinical trials there is no strong adverse effects (just weak) reported except when patients die.
This is 100% false. All adverse events need to be reported, whether caused by the drug or not. This is why relatively innocuous drug have weird side effects like "diarrhea, constipation". The top adverse events have to be reported, even if it's 0.01% who had them.
> Moreover, the hospitals that implement the trial often only do the minimum to satisfy the principal investigator
No, the hospital doesn't know which patient received the drug or not. If the patient needs a blood test, they get a blood test like any other patient.
And again, the process needs to be followed or else the deviation reported. All of that is reported to the FDA. If enough deviations happen, the FDA can say they won't approve the drug.
> Just look at the field of neurodegenerative diseases or ask patients how negligently they have been treated.
What are you talking about? Can you provide a source?
You've already made many statements that are clearly false, which you would know if you had done even basic research into the field using google. You clearly don't know the field very well, so I'm not sure why you feel like your "ideas" of how trials are run are of any value.
I think GP may be referring to CROs who generally do most of the ops of a clinical trial. Their incentive isn’t to have positive results though, it’s to milk the trial contract (cost plus contracting w/ ~no incentive to operate them quickly and efficiently) and then to have the results never get disputed by FDA. A CRO that fakes data is a CRO that will not survive very long.
Agreed on all your other points though, GP has no clue what they’re talking about.
And there is global shortage right now.