Recently there were a number of posts around patient centricity in clinical trials as put on LinkedIn by Brad Hightower.. The idea, if I got it right, is that the participants in a trial are not really patients asa far as a trial is concerned. There is some truth to this point of view. The sponsors of the trial are not looking to treat patients as mochas they are wishing to test their products for efficacy and safety on trial participants.
Phase I trials are typically the easiest to make this distinction. In many of those trials, which are about safety, the participants do not have the condition for which the product is being tested. Both they and the sponsor and the site do not consider them as patients at all. They are participants.
As the sponsors and researchers wish to test their article on patients the situation acquires a complexity. When actual patients become interested, they may have motives other than furthering understanding. One should keep in mind that altruistic motives exist. However, it is also true that participants can have multiple motivesA participants may be seeking out a better treatment and would like to also further understanding.
Meanwhile back at the sponsor/researcher the protocol is looking to test participants. It wouldn’t be necessary if everyone knew it worked and was safe at the same time. There is no guarantee the participant is getting treatment.
In essence we have two different visions of the experience. Participants may be seeking a novel treatment and would classify themselves, most likely as patients. Sponsor/researchers would classify them as trial subjects. Observational studies excluded here.
The point of how to focus the protocol to make it more aligned with a research perspective I think will miss the mark a bit. My own experience is that protocols can be unsuccessful for a number of reasons. One is that it doesn’t understand the participant population and its view of being in a study. Even if a synopsis sounds good the data collection might be onerous. Examples include a battery of labs and site visits, plus numerous questionnaires. These should probably be limited to answering the specific questions regarding efficacy and safety and not being used to validate a questionnaire or collect information that would be useful to marketing as being required activities of the participant or the site.
Focus can bring about better protocols meaning protocols that can be successfully implemented. Speaking to patients about an idea for a protocol before writing it up sounds like good advice to me. Likewise speaking to recruiting sites and not just renowned experts can also be advantageous.
What to do with particpant/patients thinking of this as treatment is a hard nut to crack. But it doesn’t seem to be something that would slow down enrollment.
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