An interesting article: Your Review: Participation in Phase I Clinical Pharmaceutical Research
Selected excerpts:
In the great majority of studies, you will not experience any noticeable effects from the medication. If you do, you probably will not report them. In fact, in the event that they experience significant symptoms, participants have strong incentives to actively conceal them, and most of them know this.
If you do it regularly, clinical research participation pays on a scale comparable to a regular job, but it’s not a regular job. There is no screening for work experience or skills, or for criminal history, something which a not-insignificant portion of the clinical research population has. Officially, the participant population is very healthy, with no recent diseases or drug use of any kind, not just recreational, but prescribed or over-the-counter for any sort of condition whatsoever, and no medical history of any sort of ailments you might think to include on a survey form. In practice, beyond the requirement of being able to pass medical screenings, study participants have every incentive to lie. If you pass screening, you are probably not on drugs at that specific point in time, although according to clinic staff, it’s not particularly unusual for applicants to try to get away with this. In general, the selection process tilts the participant population towards what might broadly be considered shady characters. People who don’t get along well with traditional employment (it’s hard to reconcile with the scheduling commitments of clinic research,) are comfortable pursuing an avenue of income which is widely perceived as dangerous when people think about it at all, and are generally distrustful of and comfortable lying to authority figures (a useful trait for remaining an active participant in clinical research.)
The requirements clinical researchers are forced to comply with are well in excess of what’s necessary for participants to reliably avoid lasting harm to their health, and the practices of research clinics tend to filter out participants who are honest with them.
Research participants who disclose information to the clinics too freely tend to learn quickly that this is not in their interests. Admitting to any sort of medical condition, medication use, or history of medical events, tends to result in participants simply being told they are not eligible for the study they wish to screen for.
Another factor which incentivizes participants not to be honest with clinic staff is that they simply get paid more if they aren’t. Even for study participants who genuinely meet all the medical criteria in the screening and study protocols, there’s one factor that affects all participants and is consistent between all clinics and studies, which affects participants’ ability to profit from their involvement in clinical studies. Participants are required to observe a washout period (usually at least 30 days, but this varies between study protocols, and may be as much as 90 for some studies) between the last time they were dosed with any experimental medication, and when they’re next able to participate in a study. Most clinical research participants treat studies as a regular source of income, and prefer not to comply with this, as it limits how frequently they’re able to get paid for participating. Staff at an individual clinic won’t let a person enroll in multiple studies too close together at the same clinic, but most research participants travel around the country to enroll in studies at different locations. Participants who’re willing to lie and claim that they haven’t received any experimental medications in the last month when they actually have are simply able to earn substantially more money than participants who’re unwilling to do so.
A participant who reports an unusual reaction to a study drug may go on the record with that clinic as having an unusual sensitivity or allergy to that medication. And having unusual sensitivities or allergies to any sort of medication is an exclusion criteria for almost all clinical studies. […] A participant who experiences symptoms which make them genuinely worry about the prospect of receiving more of the study drug can always simply make an excuse and drop out of the study, something all participants are entitled to do as part of the legally mandated protections involved in clinical research. This would come at the cost of the payment for the rest of their involvement in that study, but better that than being permanently barred from all studies with that company.
The overwhelming majority of Phase I pharmaceutical trials are almost certainly being performed on participants who’re not in compliance with the study criteria, and who’re not reporting all the symptoms they experience while taking the experimental medications. But many symptoms, most of the ones most directly relevant to participants’ health, can be caught by the regular medical tests which participants undergo throughout their involvement in the clinical studies.
Most of the study criteria which participants habitually violate probably don’t matter very much, in terms of the actual outcomes of the studies.
At least some of the pathologies of this system probably propagate down to later levels though, and it’s difficult to say how much. In general, if you want to study anything at all, it’s better to make sure you have a system for doing so which encourages the people involved to be honest.