Clinical trial diversity must improve to ensure drugs work for all.
The pharmaceutical industry has a problem. Every year companies spend billions of dollars on clinical trials to assess the efficacy and safety of medicines—yet for large sections of the populations they serve, the results are simply not good enough.
Clinical trials are falling short by routinely failing to accurately reflect the diversity of different patient groups. This means the data they generate is not painting the full picture of the good (and sometimes bad) that modern medicine can do.
Race, ethnicity, sex and age all affect how different people respond to the same medicine, vaccine or other medical intervention. Unless trial participants testing a new therapy are representative of those who will use it, there can be no certainty as to how it will work in medical practice.
What is more, physicians may be reluctant to prescribe new medicines to groups of people who were under-represented in clinical trials, resulting in the effective exclusion of those groups from the potential benefits of ground-breaking medical research.
Unfortunately, it is the most vulnerable individuals in society, especially those in non-white communities, who are the biggest losers since they are the ones who are most under-represented.
“The magnitude of the disparity is much greater than people realize, especially among patients who identify as Black,” said Professor Kenneth Getz, Executive Director of the Tufts Center for the Study of Drug Development in Boston, one of the world’s leading experts on clinical trial practices and trends.
“Any insights into the efficacy and the safety of a given treatment are sub-par until researchers have a deep understanding of the entire diverse population that might benefit from that therapy. Without it, our drug approval process is incomplete.”