Ethics of Pharma Clinical Trials in the Era of Precision Oncology
| Autor: | J. Harvey Turner |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
Cancer Research
medicine.medical_specialty Minimal Clinically Important Difference Antineoplastic Agents Medical Oncology law.invention Quality of life Randomized controlled trial law Neoplasms Overall survival Humans Medicine Radiology Nuclear Medicine and imaging Precision Medicine Intensive care medicine Randomized Controlled Trials as Topic Pharmaceutical industry Pharmacology Clinical Trials Phase I as Topic business.industry Patient Selection General Medicine Clinical trial Oncology Precision oncology Quality of Life Biomarker (medicine) Human research business |
| Zdroj: | Cancer Biotherapy and Radiopharmaceuticals. 36:1-9 |
| ISSN: | 1557-8852 1084-9785 |
| DOI: | 10.1089/cbr.2020.4129 |
| Popis: | Pharmaceutical industry clinical trials are ethically problematic: human research subjects are being used as a means to the end of demonstrating statistically significant efficacy of novel anticancer agents to achieve regulatory registration and marketing approval. Randomized controlled trial design is inequitable since control arm patients are denied access to the postulated best treatment. Most pharma studies do not provide clinically meaningful benefit of increased overall survival and enhanced quality of life (QOL) to cohorts and are not reliably generalizable to real-world patients. Precision oncology now enables prospective identification of patients expressing a specific cancer biomarker to determine their particular eligibility for evaluation of efficiency of molecular-targeted treatments. A patient-centered approach, collecting prospective real-world data in large populations, could provide real-world evidence of cost-effective, sustained clinical benefits of survival and QOL, while preserving the ethical beneficent compact between patient and doctor. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|