Analyses of the Rationale and Implementation of Research Biopsies in Oncology Clinical Trials at a Tertiary Cancer Center.
Nathalie OlympiosLaetitia ColletMarianne PaesmansChristiane JungelsNuria KoteckiAhmad AwadaPhilippe AftimosPublished in: The oncologist (2021)
In 2019, the American Society of Clinical Oncology (ASCO) developed an ethical framework to provide guidance on incorporating research biopsies in clinical trials. This study underlines the growing request for tissue in clinical trials with potentially no impact on drug development and no benefit to actual or future patients. Adherence to ASCO's Ethical Framework decreases through time. These results highlight the importance of improving the ethics of research biopsies. ASCO's Ethical Framework offers an opportunity to improve quality of care in clinical research by maximizing scientific utility and allowing for clinically meaningful correlative science and safe access to innovative treatments for a maximum number of patients.
Keyphrases
- clinical trial
- end stage renal disease
- ejection fraction
- palliative care
- newly diagnosed
- chronic kidney disease
- healthcare
- public health
- type diabetes
- prognostic factors
- quality improvement
- machine learning
- metabolic syndrome
- open label
- artificial intelligence
- ultrasound guided
- phase iii
- phase ii
- insulin resistance
- papillary thyroid
- glycemic control