Clinical Trials Can Make Anyone a Hero
By Raolat Abdulai, MD, Clinical Research Director at Sanofi
I am an accidental hero. Because of a choice I made years ago, I have saved lives.
I’m not talking about the choice I made to become a doctor, although I have saved the lives of patients in the hospital. Years before I was even a medical student, I made the choice that made me a hero – although I never expected to be one.
It started with nothing more than a piece of paper that I tore from an advertisement on a bulletin board at the National Institutes of Health. It was an ad for a clinical trial that needed participants. Like many young people working in labs there, I wanted to make a little extra money, and thought that’s all I was doing.
It turned out to be much more: It began my journey into the world of clinical research.
My first study required that I spend two hours in an MRI machine watching videos. There were some funny ones and others that were scary. As I watched them, researchers scanned me in order to determine which parts of my brain were most active when I expressed the different emotions the videos invoked.
The next day, when I returned to the lab, a colleague showed me her arm. It was wrapped in cellophane to protect the injection sites where she had received doses of an investigational intradermal drug. She was enrolled in a study assessing a new, and potentially safer, method of administering an old drug.
We both looked with curiosity at her arm. Neither of us would have thought of ourselves as heroes. But that’s what had become. Without human clinical trials like those, researchers could never develop newer, safer, or more effective ways to treat disease – and save lives.
As we mark Clinical Trial Awareness Day this month, it’s important to remember not only the value of human clinical research, but also the serious challenges it has faced. Some of them are still with us at a time when we need new heroes.
Forty years ago marked a landmark moment in clinical research: the publication of the Belmont Report. That was the culmination of more than four years rel="noopener noreferrer" of research by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The commission rel="noopener noreferrer" was formed in part due to the results of the Tuskegee experiment, the infamous and cruel syphilis experiment performed, without consent, on African-American men in the South. The hope was to never have a repeat of the Tuskegee experiment or other instances of inappropriate research conduct. The Belmont Report changed how human research would be performed by establishing three ethical principles:
- Respect for Persons – Acknowledging autonomy and protecting those with diminished autonomy
- Beneficence – Do no harm; maximize possible benefits and minimize possible harms
- Justice – Fair treatment and distribution of benefits
As a result, there is now increased oversight of clinical trials and many of the goals of the Belmont Report have been achieved.Today, volunteers in clinical trials are viewed more as equal partners in the research, fully informed of their rights, as well as of the potential benefits and risks of participating in such investigations. In addition, clinical research is conducted under a harmonized set of international rules and regulations intended to protect the safety and wellbeing of trial participants irrespective of where the trials are conducted in the world.
It is “justice,” however, that has yet to be truly achieved. There is a troubling lack of diversity among clinical trial participants. There are far too few people like me taking part: People of color and members of minority communities are woefully underrepresented. Because of this, the results of clinical trials are skewed and the benefits of new medicines are not distributed fairly.
Globally, white participants represent about 78.6% of all clinical trial participants, a figure far greater than in the population as a whole. Asians represent only 11.8% of participants, while black participants of African descent make up just 5.4% of those enrolled in clinical trials. When it comes to clinical trials in certain therapeutic areas, this disparity is even greater. African Americans represented only 2.5% of participants in cardiovascular trials, and 2.74% in oncology trials in 2015-2016, according to the FDA.
This has enormous implications, given the prevalence of cardiovascular disease and aggressive cancers among African Americans. For example, lung cancer occurrence is 15% higher in black men and multiple myeloma is 2.5-3.5 times higher in black men and women under age 50 than their white counterparts (DeSantis, Miller, et al. 2019). Yet, we have learned that women and people of color may respond differently to the same medication due to genetic variances (Coakley, Fadiran et al. 2012). Without broadly diverse participation in clinical trials, we are unlikely to understand the race, ethnicity, and gender related differences in drugs – differences that can save lives.
One example is the positive impact of tyrosine kinase inhibitors in Asian females with certain types of lung cancer. These drugs have led to a 26% reduction in death for Asian female compared to about 16% reduction for non-Asian males (Becker, Wisnivesky, et al. 2017). That knowledge was only possible because of the heroes who volunteered to participate in the studies around those drugs.
How can we achieve this third principle of justice outlined in the Belmont Report and ensure that everyone shares the benefits of research? The answer is to actively encourage more participation in trials by minorities, particularly women, with the research community and its allies reaching out to these groups to let them know how their participation in such investigations could contribute to efforts to fight against the diseases affecting their communities. That will take an active and prolonged effort, because most people don’t even know that they have the chance to be heroes.
I was fortunate: Working in a research laboratory setting, my opportunity to become a hero was right in front of me on that bulletin board. That choice to respond, to make a little extra income, led me on that path to becoming an accidental hero. But we can’t rely on such happy accidents to bring the diverse participation science and society need. When people in every community understand what an extraordinary gift they can make to society by enrolling in trials – and when we make it possible for them to choose to become the new heroes -- we will meet that third goal of justice and ensure human clinical trials benefit everyone.