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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
- Source :
- Journal of Clinical Oncology. 35:3753-3759
- Publication Year :
- 2017
- Publisher :
- American Society of Clinical Oncology (ASCO), 2017.
-
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.
- Subjects :
- Cancer Research
medicine.medical_specialty
Biomedical Research
Population
Alternative medicine
Eligibility Determination
Renal function
Comorbidity
Medical Oncology
Malignancy
03 medical and health sciences
0302 clinical medicine
medicine
Humans
030212 general & internal medicine
education
Clinical Oncology
education.field_of_study
business.industry
Organ dysfunction
medicine.disease
United States
Original data
Clinical trial
Oncology
030220 oncology & carcinogenesis
Cancer research
medicine.symptom
business
Subjects
Details
- ISSN :
- 15277755 and 0732183X
- Volume :
- 35
- Database :
- OpenAIRE
- Journal :
- Journal of Clinical Oncology
- Accession number :
- edsair.doi.dedup.....472d0f9dd02bee8f7f7d07d382ab852e