An article published last week in Science Translational Medicine weighed up the pros and cons of various incentives used to encourage participants to enrol in clinical trials.
The incentives used to encourage trial participants range from good old-fashioned cash to pragmatic things like lifts to the clinic. The new article applies behavioural economic theory to clinical trial enrolment incentives by “addressing the patient barriers of imperfect information, desire for autonomy in making enrolment decisions, and resource constraints.”
Part of the decision to enrol (or not) in a trial is, the article argues, based on social norms – if lots of other people think it’s OK, it must be safe.
Personally, I don’t assign much credit to the discernment of the herd; otherwise I’d be spending all of my time playing Pokémon Go (as opposed to about 25% of my time).
The rules of Good Clinical Practice are quite clear in that the risk and benefit to the participant must be adequately spelled out in terms they will understand. Social norms may inevitably influence people to consider clinical trials in the first place but they should play no part beyond this.
One passage in the article rings a few alarm bells – “the presence of a physician in the room while patients are considering participation may reduce time spent reading information if patients assume the risks have been vetted by the physician or if patients feel pressured to not waste the physician’s time.”
I think this is probably a good point but the potential negative effects need to be balanced with the requirement (under GCP) for participants to be given the opportunity to discuss any risks and concerns with a doctor.
The article goes on to recommend against providing consent documents at the end of an appointment may unwittingly discourage attention to the information, as patients may be impatient to move on with their days.
There are a lot of things that recruiters can do to help encourage participants without crossing any ethical boundary – offering a choice of clinical appointment times is one. Education about the way in which clinical trials work is also very helpful and should encourage potential participants to get involved more than those in total ignorance.
Searchable online databases of trials and recruitment criteria can help too but of course these rely on potential participants having enough knowledge to look in the first place.
One thing I find a little surprising is the mention of opt-in being the default position for low-risk trials. This approach has been used quite successfully in organ donation but surely clinical trials are a totally different thing.
Perhaps, I’m being naive, but the comment that “default enrolment is now increasingly common in minimal risk, pragmatic clinical trials,” is news to me.
I can appreciate that this approach would increase “both the rate and diversity of patient accrual” but can it be ethical?
The definition of what constituted a “low-risk” must be determined by an ethics committee (IRB) but I imagine many of them would be extremely wary if the result could be that participants become automatically enrolled.
The idea that inclusion in a trial would be in the patient’s likely benefit is already a pillar of GCP – automatic enrolment seems to be pushing things rather too far for my liking.
I can see both sides but the fact that patient recruitment is so difficult and expensive shouldn’t in my opinion be an excuse to take a skewed view of the ethics of enrolment.
Good Clinical Practice is there for a very good reason.