Trial Participants Are Heroes, Let’s Treat Them That Way

Clinical trial participation is the most important factor to enable pharmaceutical, biotech, and medical device companies to move their medicines and treatments forward to improve the health of all of us. We all know someone that is on a medicine that was not available 30 or even 15 years ago that have had amazing benefits for those patients. Everything from a statin for cholesterol to cancer treatments like Keytruda, Opdivo, and Tagrisso.

We all know how difficult it is to recruit people into a clinical trial, and we all read that on average the dropout rate of a study is around 30%. Why is that? And what can be done about it?

I believe that there is a macro problem that needs to be solved. And that is that we as a global society do not treat clinical trial participants like the heroes they truly are. Make no mistake about it, being a clinical trial participant, especially in an interventional trial, is a sacrifice of time and body and represents a true commitment on the part of the patient.

Like many of you, I have traveled extensively for business, and one day it hit me. After passengers needing extra time, the next group to board a plane are active military. I have no issue with that—those people are making a sacrifice, but why not clinical trial participants? That is also a sacrifice for the greater good.

Beyond the macro problem mentioned above, we have an opportunity to keep patients more engaged once they are in a trial—and potentially lower the dropout rates. Reasons for the high rates have been cited as inconvenience, complexities of the trial, fear and anxiety, lack of appreciation, and scheduling conflicts. Also, once a patient is in the study, how do we keep that individual compliant so, at the end, the data that has been collected is complete and usable in the analysis?

We currently have technology available to us to make this retention and compliance much better. An increasingly larger number of trials are using patient-reported data as part of primary and secondary endpoints. A large portion of this data is being collected directly by the patient away from the clinic and usually on a device that they have—either their own phone or one that was provided for the clinical trial.

This gives us the opportunity to improve engagement, compliance, and, as a result, retention. In addition to telling the patient what questionnaire (or instrument) they need to fill out when, we can also ask the question, “What do patients need to be willing and active participants in the trial?”

We can answer that question by providing information about the trial; we can ask questions that are not clinical in nature to find out if the participant feels valued, or if being in the trial is a burden to them or their family.

And, most importantly, we can say thank you each step of the way.

This sounds simple to do, but it is not. The current state of play from most providers of electronic patient-reported outcome (ePRO) tools are just to deliver the text-based questionnaires and perhaps a reminder or two to fill them out on time.

These companies typically do not approach the problem with the right level of empathy for the patient, as to what they are going through to be in the trial.

In order to keep the trial participant more engaged in the study, we need to give them an experience that is more akin to the apps that they use every day.

This is a topic that can be discussed for hours. But I do believe we are at a point that a huge difference can be made—on behalf of the study participant—with technology and a recognition of the sacrifice that is being made for the greater good.