Bottom line: Patients with treatment-refractory cancers who received eligibility and testing waivers to participate in a large basket/umbrella oncology trial had similar rates of clinical benefit and adverse events as patients who participated in the trial without waivers. Journal in which the study was published: Clinical Cancer Research , a journal of the American Association for Cancer Research (AACR) Author: Hans Gelderblom, MD, senior author of the study and chair of the Department of Medical Oncology at the Leiden University Medical Center in the Netherlands Background: Eligibility requirements for clinical trials help protect patients whose comorbidities may put them at an additional risk of severe harm from the treatment being tested. Further, they help ensure that analyses are performed on a carefully controlled population, minimizing outliers that could skew the data.
However, the patients who will eventually receive the treatment are not homogeneous. New therapies hitting the market have not always been tested in patients with diverse backgrounds and medical histories. A 2015 study found that 39% of patients treated for renal cell carcinoma in clinical practice would not have been eligible for the trials leading to the approval of the drugs they received.
Among patients in the general population treated with osimertinib (Tagrisso) for non-small cell lung cancer, 62% would have been ineligible for the phase III trial. "It is well known that results in an 'ideal' pop.
