Participant Perspective Vital in Clinical Trial Discussions
About a decade ago while pursuing my graduate studies, I had a chance encounter with a clinical research participant that left an indelible impression upon me. As an exuberant clinical research associate, I entered the consulting room to take the would-be participant through a clinical trial consenting process. Essentially, this is a process of ensuring that the participant has had ample time to read (if literate) and understand information detailing every aspect of the study before committing to the study with the understanding that s/he is free to withdraw from the study at any time. This was a study I was very excited about since it involved marketed medications for hypertension and our participants were going to freely receive them. Additionally, many of our participants were going to receive more extensive medical care beyond what they would routinely receive (or may not have access to) in the management of their hypertension. This perspective erroneously filled me with a sense of purpose in the knowledge that we were doing our participants “good” by enrolling them in the study. Little did I know that I was about to learn one of my most profound professional lessons from one of my study participants. It was during the consenting process as I explained the benefits (and risks) of participating in the research to the participant that I received a sharp rebuke (paraphrasing): You aren’t even a ***** (expletive for African American)! You’re an African!! For a long second or two I was stunned. Did I say or do anything wrong? The would-be participant then continued to explain to me why gaining perspective of the other stakeholder’s viewpoint when it comes to clinical trials communications should be the first step in any related discourse. How true have those words of wisdom rung through the years!
Clinical trial participation and its related discussions are very personal and emotive experiences amplified by the inherent unknowns associated with research activities involving human life. As such, scientific justification alone cannot be used to address the concerns of would-be participants and the general public. This is especially more so when it involves people from communities with histories of misdeeds, exploitation and huge institutional voids such as those prevalent in many health systems on the African continent. An additional complexity to clinical trials conversation is that the modern would-be participant or the general public is socially and digitally plugged-in and constantly connected. With this complexity comes issues of inaccurate social commentaries about clinical trials, drug/vaccine developments and the resultant fear. Recognizing that clinical research can be a technical and difficult subject to explain, effective communication becomes an investigator’s best tool. For communication to be effective, it must include some key ingredients such as a good appreciation of the recipient’s perspective, transparency and a willingness to receive feedback from a non-technical person. These ingredients ensure that the participant is met where they are. Over time, this lesson of meeting clinical trial participants “where they are” has proved beneficial in multiple instances. This is because, the participant today seeks to be much more involved in his/her healthcare management. Today’s participant wants better accountability, more voice, and to be regarded as a stakeholder in the clinical research process and not merely as a test subject. Failure to attend to this new reality can lead to sensational news coverage and distrust resulting in missed opportunities to inform and educate the public.
Memories of my chance encounter quickly sprang to mind following the recent media furore surrounding a pair of scientists’ comments about clinical trials and vaccine testing in Africa. Following the scientists’ pronouncements, the backlash that promptly followed was evidence of the fine balance between what could have been good scientific intent and a disappointing missed opportunity. This is because, the thing that draws most well-meaning persons to a career as a clinical research professional is the same thing that potentially could be one’s undoing if not constantly held in check. By this I mean, most clinical research professionals are mostly motivated by an intrinsic desire to do good through careful scientific inquiry to address medical needs. However, in most instances the clinical research process does not adequately involve opportunities to meet participants where they are. This leads to no communication, misinformation and worsens the general suspicion that some people have for clinical trials. It is my opinion that, had the scientists explained why the development of a vaccine for COVID-19 should involve Africans without attempting to justify testing in Africa using sub-optimal historical examples, the outcome might have been different. This is because, there are several reasons why one might consider including Africa in the development of such a vaccine program. Some of these are that, though some vaccines are designed for treatment (therapeutic vaccines) the discussion here was putatively about prophylactic vaccines (for prevention) and not for treatment of disease. Therefore, the proposed prophylactic vaccine should be made available to those not infected by the virus. Further, given that the reported COVID-19 infection rates in Africa were relatively low compared to those of other parts of the world, it stands to reason that any subsequently available vaccine must be made available to individuals who have not been infected by the virus. Furthermore, given the generally under-resourced health system across the African continent, an exponential increase in infection rates similar to those observed elsewhere would have dire consequences on the continent. However, even before listing the scientific merits for proposing the inclusion of Africans in a COVID-19 vaccine development, an appreciation or sensitivity to some of the past events involving the conduct of clinical trials in Africa should have guided the discussion. Alas, a good teaching opportunity missed!
The current COVID-19 pandemic is certain to change our world as we know it and clinical research will not be an exception. Another thing that must change though is a world in which Africans are continually uncomfortable with the clinical research process due to historical misdeeds, lack of proactivity on the part of health professionals to engage or inadequate regulatory updates and protections to assure safe participation in clinical trials. These and many more would have to be addressed to ensure that Africa Clinical Trials version 2.0 launches successfully and alleviates many of the health issues blighting the continent.
Derrick E. Akpalu, PhD, MSCR is a D&D Fellow for CDD-Ghana and Principal Clinical Research Scientist for Johnson & Johnson. The views expressed in the foregone are solely his and not representative of the views of either of the institutions he is affiliated with.