RECOMMENDATIONS for wider eligibility criteria for cancer clinical trials are being voiced by The American Society of Clinical Oncology (ASCO) and Friends of Cancer Research (Friends). Following an extensive review of current eligibility criteria, it was noted that there was a lack of inclusion for patients in five particular areas: HIV/AIDS status, organ dysfunction, minimum age requirements for trial enrolment, prior and concurrent malignancies, and brain metastases.
Eligibility criteria are put in place to ensure the safety of those who take part, especially those participants who may be at a greater risk of experiencing adverse effects to the trial drug. However, if these eligibility criteria are too strict, it reduces the ability to generalise the results to the population as a whole. In addition, when it comes to treating patient groups who were not included in the trials, there is a lack of data available regarding safety and efficacy, leaving them at a disadvantage.
ASCO and Friends began work on the collaborative project in 2016. The five areas identified were examined by a wide variety of working groups, including researchers, patient managers, regulators, and industry representatives, in order to create recommendations for modifying the eligibility criteria. It was found that the concerns affecting the criteria were not actually confirmed by data in many cases. As a result, the lack of data leaves patients unable to benefit from any advances in cancer medicine, because they are rarely able to access new cancer agents.
Dr Bruce Johnson, ASCO President, said: “This joint initiative provides a roadmap for how to safely employ broader eligibility criteria for cancer clinical trials and promote a culture of inclusion.” Dr Jeff Allen, President and CEO of Friends, also commented: “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.”
ASCO and Friends held a meeting with stakeholders across the research community, where they discussed the broadening of eligibility criteria, including the enforcement of wider inclusion strategies. Work will continue with these organisations to ensure the recommendations come into action, creating huge potential for future cancer clinical trials and patient participants.