by Maneet Kaur, PhD, epidemiologist and senior scientist at Flatiron Health, New York, and colleagues. Flatiron Health is an independent member company of the Roche group and sponsor of the study.
"The topic addressed by Kaur and colleagues is certainly not new. As early as 1997, the National Cancer Institute noted that overly restrictive criteria in clinical trials led to results with poor reproducibility in the real world," Celeste Cagnazzo, biologist manager at the AOU Città della Salute e della Scienza in Turin, Italy, and president of the Italian Group of Data Managers-Clinical Research Coordinators, told Univadis Italy.
Expanding eligibility criteria could be a step toward including the entire population in clinical trials. Experts explain that defining eligibility criteria is not so simple, however, and despite the interest of the medical-scientific community and regulatory bodies, the issue of truly equitable population inclusion in clinical trials has not yet been definitively resolved."It's about finding a balance between the internal and external validity of the study," said Cagnazzo.
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