Modernizing clinical trial eligibility criteria: Recommendations of the American Society of Clinical Oncology-Friends of Cancer Research Organ Dysfunction, Prior or Concurrent Malignancy, and Comorbidities Working Group Journal Article


Authors: Lichtman, S. M.; Harvey, R. D.; Smit, M. A. D.; Rahman, A.; Thompson, M. A.; Roach, N.; Schenkel, C.; Bruinooge, S. S.; Cortazar, P.; Walker, D.; Fehrenbacher, L.
Article Title: Modernizing clinical trial eligibility criteria: Recommendations of the American Society of Clinical Oncology-Friends of Cancer Research Organ Dysfunction, Prior or Concurrent Malignancy, and Comorbidities Working Group
Abstract: Purpose Patients with organ dysfunction, prior or concurrent malignancies, and comorbidities are often excluded from clinical trials. Excluding patients on the basis of these factors results in clinical trial participants who are healthier and younger than the overall population of patients with cancer. Methods ASCO and Friends of Cancer Research established a multidisciplinary working group that included experts in trial design and conduct to examine how eligibility criteria could be more inclusive. The group analyzed current eligibility criteria; conducted original data analysis; considered safety concerns, potential benefits, research, and potential hurdles of this approach through discussion; and reached consensus on recommendations regarding updated eligibility criteria that prioritize inclusiveness without compromising patient safety. Results If renal toxicity and clearance are not of direct treatment-related concern, then patients with lower creatinine clearance values of . 30 mL/min should be included in trials. Inclusion of patients with mild to moderate hepatic dysfunction may be possible when the totality of the available nonclinical and clinical data indicates that inclusion is safe. Ejection fraction values should be used with investigator assessment of a patient's risk for heart failure to determine eligibility. Patients with laboratory parameters out of normal range as a result of hematologic disease should be included in trials. Measures of patient functional status should be included in trials to better assess fit versus frail patients. Conclusion Expanding inclusion of these patients will increase the number and diversity of patients in clinical trials and result in a more appropriate population of patients. © 2017 by American Society of Clinical Oncology.
Keywords: adult; aged; major clinical study; clinical trial; liver function; united states; cancer adjuvant therapy; antineoplastic agent; organization and management; biomedical research; nephrotoxicity; breast cancer; lung cancer; oncology; bladder cancer; cancer research; hematologic malignancy; cardiovascular risk; heart failure; colon cancer; medical research; patient safety; comorbidity; medical society; medical oncology; functional status; cardiomyopathy; multiple organ failure; heart function; eligibility determination; heart ejection fraction; procedures; humans; human; priority journal; article; malignant neoplasm; moderate hepatic impairment
Journal Title: Journal of Clinical Oncology
Volume: 35
Issue: 33
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2017-11-20
Start Page: 3753
End Page: 3759
Language: English
DOI: 10.1200/jco.2017.74.4102
PUBMED: 28968172
PROVIDER: scopus
DOI/URL:
Notes: Article -- Export Date: 2 January 2018 -- Source: Scopus
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  1. Stuart Lichtman
    163 Lichtman