Ethics of Pharma Clinical Trials in the Era of Precision Oncology.
Cancer Biother Radiopharm
; 36(1): 1-9, 2021 Feb.
Article
in En
| MEDLINE
| ID: mdl-32935997
ABSTRACT
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.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Randomized Controlled Trials as Topic
/
Clinical Trials, Phase I as Topic
/
Patient Selection
/
Medical Oncology
/
Neoplasms
Type of study:
Clinical_trials
/
Prognostic_studies
Aspects:
Ethics
/
Patient_preference
Limits:
Humans
Language:
En
Journal:
Cancer Biother Radiopharm
Journal subject:
FARMACIA
/
FARMACOLOGIA
/
NEOPLASIAS
/
TERAPEUTICA
Year:
2021
Document type:
Article
Affiliation country:
Australia