The randomized clinical trial, widely considered the most reliable biomedical research method, can have significant drawbacks, a new study suggests, because patients included may not be representative of the broader population.
Participation in Surgical Oncology Clinical Trials: Gender-, Race/Ethnicity-, and Age-based Disparities (The Annals of Surgical Oncology)
The scientists, writing in the December issue of The Annals of Surgical Oncology, reviewed 29 clinical trials of surgical procedures in prostate, colon, breast and lung cancer involving 13,991 patients. Although 62 percent of those cancers occur in people over 65, just 27 percent of the participants in the trials were that old. Although patients younger than 55 account for 16 percent of cancer cases, they made up 44 percent of the participants. More than 86 percent of the participants were white, and fewer than 8 percent African-American.
Thirty percent of the cases were breast cancers, but nearly 75 percent of the participants had that disease. Although prostate cancer accounted for 27 percent of the cancers, fewer than 2 percent of the patients were in prostate cancer studies.
In colon and lung cancer trials, women were less likely to be enrolled than men, and at all study sites, the rates of participation in trials was extremely low, from 0.04 to 1.7 percent.
Dr. John H. Stewart IV, the lead author and an assistant professor of surgery at Wake Forest University, said the disparities could call the results into question. “Our ability to generalize the findings of surgical trials,” he said, “is directly dependent on having equitable participation in trials by underrepresented groups.”