Cancer patients with comorbid disorders are less likely to be offered the opportunity to take part in a clinical trial, according to a study published in JAMA Oncology.
The data, collected by the SWOG Cancer Research Network, was taken from a US-wide survey of 5,499 patients diagnosed with lung, colorectal, breast or prostate cancer.
The majority (66%) of these patients were identified as having one or more of 18 different comorbidities. The most commonly reported were hypertension, vision loss, arthritis, asthma, hearing loss, and a previous cancer.
The study revealed that the presence of a comorbidity resulted in a decrease of 15% in trial discussions with care providers, a decrease of 23% in trial offers by a care provider, and a decrease of 24% in trial participation, when compared to those without comorbidities. This was true even after accounting for variables such as age, sex, race and income.
Regulatory change is recommended to allow cancer patients with comorbid illnesses to take part in clinical trials
SWOG’s survey was conducted to better understand proposed regulatory changes issued by the Food and Drug Administration (FDA), the American Society of Clinical Oncology (ASCO) and Friends of Cancer Research (FCR).
In autumn 2017, the groups collaboratively published a series of papers in the Journal of Clinical Oncology. These papers aimed to establish a set of new rules on clinical trial comorbidity which would allow a wider pool of cancer patients with secondary illnesses to take part.
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The FDA, ASCO, and FCR recommended modifying participation guidelines to allow patients as young as 12 years old, with brain metastases, HIV/AIDS, prior cancer diagnoses or organ dysfunction to take part in clinical trials.
SWOG health services researcher and biostatistician Joseph Unger, who led the research, said: “[Opening up cancer trials to comorbidities] would have the short-term impact of helping patients by giving them access to new treatments and have a long-term impact on the discovery of new treatments, speeding the time it takes to run trials and get new treatments to the public.”
Assuming 1,735,350 new cases of cancer are diagnosed in the United States annually with 5% of these patients enrolled in a clinical trial, then the lifting of comorbidity restrictions in line with FDA/ASCO/FCR recommendations would allow up to 6,316 more patients to enrol in clinical trials. Should all comorbidity restrictions be lifted, up to 11,992 more patients could enrol in a trial.