Although the purpose of eligibility criteria is to protect patients from unnecessary harm, define the study population, and allow researchers to collect safety and efficacy data for a specific population, unnecessary restriction may not capture the heterogeneity of real-world patients.
Although the purpose of eligibility criteria is to protect patients from unnecessary harm, define the study population, and allow researchers to collect safety and efficacy data for a specific population, unnecessary restriction may not capture the heterogeneity of real-world patients. This was the gist of a perspective piece authored by experts from the FDA, including Richard Pazdur, MD, who heads the Oncology Center of Excellence.
The article, published in the New England Journal of Medicine, recommends relaxing the stringency of patient eligibility requirements for trial participation, so that the presence of a more heterogenous population allows for detection of safety signals in early stages. This could help inform criteria for subsequent trial participation.
The article makes a few suggestions on potential changes when recruiting patients in oncology trials:
The authors note that a heterogenous population would broaden the labelling claims for the pharmaceutical industry
“For example, if efficacy and safety were demonstrated in patients with brain metastases, a marketing claim could include an indication for this population in addition to the general indication,” they wrote. A more heterogenous clinical trial population could also ease some of the postmarketing regulatory requirements of safety and pharmacokinetics, especially in patients with organ system dysfunction.
Reference
Beaver JA, Ison G, Pazdur R. Reevaluating eligibility criteria—balancing patient protection and participation in oncology trials. N Engl J Med. 2017;376:1504-1505. doi: 10.1056/NEJMp1615879.
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