The interaction between the HCP and the patient differs from that of the Investigator and subject in at least one important way. It can be found in the motivations of the stakeholders. There are other differences of course. Clinical research has more than two stakeholders. There are differing primary goals associated with the activity itself. One is knowledge and the other is therapeutic. The challenges arise when patients have motivations that differ from the goals of the activity. In other words, they have a different goal than the advancement of knowledge. Let’s say they have a therapeutic goal for participating. The goal of the activity, however, is to gain knowledge. The activity wouldn’t exist otherwise.
These goals are different, but they are not mutually exclusive. Of course, people can have multiple motivations for participating. Yet we do worry if a patient is participating because they think they are getting therapy. Intuitively we are concerned that the patient is making a critical decision because they have a mistaken belief that they will receive treatment. The truth is we don’t know if they will receive treatment. Even if they get into the treatment arm, we don’t know how efficacious the drug will be.
To some extent this is true in the clinical situation. Drugs are not effective for 100% of the cases, at least not typically. Sometimes this is referred to in an oblique way. “If this doesn’t work, we can try Y.” This does let a patient know that the therapy may not work.
This doesn’t mean that they (the participants) never align regarding goals and motivations. A patient can choose to be a subject of a clinical investigation because they would like to advance knowledge and that is their only motive to participate. We can ask ourselves what information needs to be shared in that case.
Often motives are mixed. Many patients agree to participate because they are hoping that they will receive a novel therapy. Moral dangers lurk in this scenario, and I am not quite sure how to deal with them. If someone is desperate for therapy and you have a placebo controlled trial which is blinded, do you let them participate?
The current question before us is about the delivery of information to a patient/subject. This has proven to be a sticky wicket in the therapeutic domain. We certainly made progress in delivering information. We have digital apps which allow for a better contoured delivery and even testing at the end to see if patients have retained all of the information provided. The flexibility of these approaches is a marked gain over pen and paper.
There remains an enormous barrier to a valid consent and that is information relevance. The data presented has to relate to what is important to a patient. In the delivery of medical care this has a rather wide range of possibilities for patients. Is this true in the research context or is there less to contend with or more? Information relevance is key.
As you may have surmised from the above, there are a number of motives a patient may have for participation. Let us start with having one motive – furthering knowledge. What would be relevant to that decision to participate? As a carve out here let us assume we are talking about interventional studies be they device or “drugs”. We will deal with observational studies down the road.
I think it should be an analog to the decision to study the problem for the researchers. What is the goal of the study? This requires some information about the condition that is being addressed by the product. What the intervention hoped to accomplish. What else is out there for patients with this condition? What are the known risks and/or benefits of the intervention?
The patient/subject needs to assess as best as possible whether the risk to themselves is outweighed by the gain of knowledge (and/or other benefits of participation such as free transportation, time remuneration etc.). This seems to be a much taller order than assessing risks and gains for oneself. At least they are personal risks and gains. In this scenario it is personal risks and public gains.
It does give us a clue as to one set of informational pieces that needs to be conveyed. The effect that the outcome of this trial may have on the relevant patient population. This can be quite complicated of course. Many factors are involved. Is this a pivotal trial or not? What is the likelihood of the intervention being efficacious? When will the knowledge bear fruit?
All of these may be relevant to my willingness to participate if my sole reason is to progress knowledge to find a treatment. This decision tree will get pretty wide pretty quickly. More next time on some answers.
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