White males overrepresented in clinical trials for first-time cancer treatment
The researchers from Penn State Cancer institute suggested that there are two problems with this tendency: patients were not receiving treatments that were likely to increase life expectancy and also that treatments designed for the general public would not reach a diverse population.
These conclusions were drawn from data on more than 12 million patients between 2004 and 2015 in the National Cancer Database. Only 11,576 (0.1%) of these patients were enrolled in a clinical trial as a first course of therapy following cancer diagnosis.
Research by the team found that those who received the clinical trial care were more likely to live longer than patients undergoing routine treatment. When quantified, this resulted in an extended median survival of seven and a half months.
However, researchers identified two well-known issues facing clinical trial recruitment – the feeling that patients had of being ‘guinea pigs’ and also the logistical challenge of finding a clinical trial center in close proximity to patients’ homes.
Diversity remains an issue
A further problem arose from this analysis – it is difficult to determine the efficacy of a treatment used in clinical trial for the general population if the treatment group is homogenous.
Researchers found that the small percentage of participants enrolling in clinical trials as a first form of therapy tended to be of a certain type: white males with private health insurance, metastatic disease, who had no other chronic medical conditions and were treated at academic medical centers.
“If clinical trials are going to be used to determine standards of care for the general population, then the study participants need to be representative of the general population — and this study shows that often this isn’t the case,” said Niraj Gusani, professor of surgery at the College of Medicine and senior author of the study.
The issue of increasing diversity in clinical trials is becoming a more pressing one and Outsourcing-Pharma recently held a webinar discussion on the topic. To this end, there have been concerted efforts over the years to increase the levels of women included in clinical trials.
The benefit to providing a more representational cross-section of society is not just to determine the efficacy of the drug in the general population but also that simply being part of a clinical trial improves the quality of care provided to the patient.
Nicholas Zaorsky, an assistant professor of radiation oncology at Penn State College of Medicine, who led the team of Penn State Cancer Institute researchers who analyzed the data, said: “Patients who go onto a clinical trial must be treated per protocol, meaning that there are many quality measures that must be met, and that there are many other health care providers looking over the patient’s care.”
