Impact of Organ Function-Based Clinical Trial Eligibility Criteria in Patients With Diffuse Large B-Cell Lymphoma: Who Gets Left Behind?
Arushi KhuranaRaphael MwangiGrzegorz S NowakowskiThomas M HabermannStephen M AnsellBetsy R LaPlantBrian L LinkJames R CerhanMatthew John MaurerThomas E WitzigPublished in: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (2021)
Current national and international trials exclude up to 24% of patients from participation on the basis of organ function alone. A significant difference in the outcomes, notably lymphoma-related death, suggests issues with generalization and potential exclusion of high-risk patients. These data will help future clinical trial development and meet US Food and Drug Administration and ASCO recommendations to increase trial accrual.
Keyphrases
- clinical trial
- diffuse large b cell lymphoma
- end stage renal disease
- newly diagnosed
- ejection fraction
- chronic kidney disease
- prognostic factors
- study protocol
- peritoneal dialysis
- phase ii
- open label
- physical activity
- adipose tissue
- phase iii
- patient reported outcomes
- metabolic syndrome
- type diabetes
- electronic health record
- double blind
- insulin resistance
- quality improvement
- big data
- artificial intelligence
- climate change