About the need to actively engage patients in clinical trials

Although a trial can be stopped for many reasons (including financial, clinical / technical reasons, administrative burden (e.g., changes in protocol), problems with patient recruitment and retention are often cited as reasons why trials have been halted.

Studies on the reasons for this dropout phenomenon simultaneously strengthen the need for regular interactions between doctor/researcher and patient as a way to defuse doubts and discouragement, and paradoxically reveal new potential for AI (Artificial Intelligence) interventions into patient recruitment. This combination of essential human touch and machine learning assets bring joy to my heart….

What are some of the important non-clinical but environmental reasons why patients enrolled in clinical trials give up and leave the process? 

Necessary caution: of course, this list is not exhaustive and  in no particular order.

Financial strain: clinical trials do have a financial impact on enrolled patients: trips to and from the research site, lost time, etc. Anticipating this financial impact can prevent some valuable patients from enrolling in clinical trials for which they would be eligible. That is why trial organizers need to be very proactive and precise in the financial commitment and retribution aspect of the trial, and communicate early on about what the trial could cost the patients, as well as how and when it will be reimbursed. I think patients cannot be truly and strongly engaged in the clinical trial journey if financial concerns are constantly on their mind.

Logistical bottlenecks: the burden of logistical arrangements (regular visits and tests, consent paperwork) is not always properly anticipated and can be overwhelming for scarce trial administrative staff. This can lead to unresponsiveness, which has a demotivating impact on patients. 

Lack of understanding: medical jargon, for instance, can be a major turn-off. Explanations, and communication in general, can never be overdone: make sure that whatever the patient needs to be informed about, approve of, commit to, or simply understand is explained to him or her clearly (have external test persons, or better UX designers involved!), several times through different channels. It is a question of efficiency, but also of respect for the patients.

The same modus operandi works for another dropout reason: fear or anxiety. While irrational and overwhelming fears, such as fears of needles, could be a reason for ineligibility (and should definitely be detected asap through specific questions in prescreening questionnaires), others could be calmed through the appropriate intervention of a medical professional. 

Beside these “environmental reasons”, I am also very much interested in dropout  motivations associated with lifestyle and predictable via machine learning devices. More about this in my next post.