I haven't read the article, but clearly this statement is true. Drug companies have a hard time getting academic physicians to follow protocols exactly as written. What's gonna happen when people who literally don't know what medicine they're taking or why (and I'm being serious...I reviewed a study once of a surgery group who was surveying patients to determine how many women who were undergoing a hysterectomy could actually name which organ(s) were being removed or why...the numbers, if I recall correctly, were about 40%) are charged with following a precise instruction, while keeping accurate and auditable records? It will not, I'm afraid, be the utopia envisioned by the author. (This is ignoring the other obvious point, which is why in the hell does anyone want clinical trials "democratized" to begin with? What possible benefit to medicine or society could that bring?)Mutherfucker has never participated in a clinical trial. My daughter makes about $300 a year to go sit in a doctor's office and eat pudding four times.
Aimmune thought things would be awesome if they came up with an app that you could record when your kid took their dose. Then it threw a couple errors. Then the FDA said people had to enter their shit into the app, because it was protocol, and also write it in a journal. And the clinicians had to compare the two. Then a year later they managed to get it so they could drop the app, but not fix the app, because it had been erroneous. Then two years later they finally got to the point where you didn't have to write down exactly what time you'd dosed, just whether or not you hadn't. That's for a dose of characterized peanut protein that your test subject has already demonstrated tolerance to in a clinical setting. That clinical setting? BP before, during and after. 3 hours of monitoring. Can't leave without an epipen. Epipen in your car? Show it to me. Expired epipen? have a new epipen.
And every. single. one. of those changes required a protocol amendment, which probably required a data review, which probably necessitated at least a phone meeting with FDA. Now multiply that by as many studies as there are registered on clinicaltrials.gov. FDA has a hard job, and putting the controls in the hands of laymen will not make it easier.