A pair of cancer organizations want to expand eligibility criteria for cancer clinical trials to certain patient groups who’ve historically been prevented from participating.
The American Society of Clinical Oncology and Friends of Cancer Research together identified five areas in which eligibility criteria were most likely to exclude certain patients from participating in clinical trials despite little evidence to support that the trials posed a safety risk. Those were minimum age for enrollment, HIV/AIDS, brain metastases, organ dysfunction and prior or concurrent malignancies.
Working groups formed last year are now recommending ways to expand access to trials for these patients in a series published in the Journal of Clinical Oncology.
“Historically, access to clinical trials has been limited to relatively few patients,” said Dr. Jeff Allen, president & CEO of Friends of Cancer Research. “Broadening the eligibility criteria for clinical trials will provide the opportunity for more people to participate in research studies. Not only will this improve access, it will make the trial results more reflective of the people that will ultimately use the drug.”
In the joint project, the organizations also argued that excluding these patient groups from clinical trials limits their access to novel cancer agents, denying them any benefits these treatments could offer.