Direct Clinical Benefit

In connection with certain types of experiments, there is a requirement that participants must have a reasonable prospect of direct clinical benefit from participating in the experiment. The following provides more details on what this precisely means, when a prospect is considered reasonable, and how any prospects of direct clinical benefit are best communicated to research participants.

What is a direct clinical benefit?

Direct clinical benefit is a health advantage that directly relates to the intervention carried out in the experiment. It is, in other words, a clinical good that directly results from the experimental treatment. To approach the concept further, it can be related to what might be called indirect clinical benefit, which is health advantages associated with participating in the experiment, regardless of whether the intervention is successful or not. Indirect clinical benefits could include special care from healthcare personnel, additional physiological examinations, and so forth. Such benefits are also called inclusion benefits, as they come solely with being included in an experiment. Besides indirect benefit, direct benefit can also be related to what might be called social clinical benefit, which are the health advantages that performing the experiment may have for others than the participant themselves. This could, for example, be the group of patients the participant belongs to. Direct clinical benefit is thus limited to the participant themselves and is limited to the potential advantages that directly flow from the experimental treatment. It is this form of benefit that must be scientifically substantiated and communicated to the participants in the types of experiments where there is a requirement for direct clinical benefit to the participants.

When is the prospect reasonable?

It is said that participants must have a reasonable prospect of direct clinical benefit. What this precisely means is a matter of interpretation. However, it's important to note that it's not the same as being certain that there will be a benefit. If that were the case, there would have been no need to conduct the experiment. Nor is it the same as all reasonable individuals choosing to participate if they were fully informed. Instead, it means a reasonable person could find the prospect of direct benefit in the specific experiment sufficient to participate, if they were fully informed about the experiment and the existing scientific literature.

How is clinical benefit assessed?

There are generally three dimensions when assessing a specific clinical benefit: character, scope, and probability. Firstly, the type of benefit matters. For example, is it about relief of symptoms, life-extending treatment, curative treatment, etc.? Secondly, the scope of the potential benefit plays a role, i.e., how intense it is expected to be and how long it is expected to last. In this respect, it's also relevant whether the treatment only has an effect while it's ongoing or if it's more lasting, and whether the effect of the treatment is expected to decrease over time. Finally, the probability of the benefit occurring plays a role. For example, in experiments in very early phases, it's less likely that there will be a direct clinical benefit from participating. The same applies if randomization in the experiment is done in a way that some participants are not offered the experimental treatment.

How is this benefit best communicated to participants?

Regarding information for participants, it's advantageous to take the three dimensions mentioned above as a starting point. That is, participants should be informed about the character of the potential benefit, how extensive it is expected to be (intensity plus duration), and how likely it is to occur. This approach is not very different from how risks are communicated to participants.

Last updated 01-02-2024
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