How to emerge from the conservatism in ...
Document type :
Article dans une revue scientifique: Article de synthèse/Review paper
PMID :
Permalink :
Title :
How to emerge from the conservatism in clinical research methodology?
Author(s) :
Kotecki, Nuria [Auteur]
Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] [UNICANCER/Lille]
Penel, Nicolas [Auteur]
221576|||Evaluation des technologies de santé et des pratiques médicales - ULR 2694 [METRICS] (VALID)
Awada, Ahmad [Auteur]
Université libre de Bruxelles [ULB]
Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] [UNICANCER/Lille]
Penel, Nicolas [Auteur]
221576|||Evaluation des technologies de santé et des pratiques médicales - ULR 2694 [METRICS] (VALID)
Awada, Ahmad [Auteur]
Université libre de Bruxelles [ULB]
Journal title :
Current Opinion in Oncology
Abbreviated title :
Curr. Opin. Oncol.
Volume number :
29
Pages :
400-404
Publisher :
Lippincott, Williams & Wilkins
Publication date :
2017-09-01
ISSN :
1040-8746
English keyword(s) :
solid tumors
innovative approach
new drugs
unmet need
network
innovative approach
new drugs
unmet need
network
HAL domain(s) :
Sciences du Vivant [q-bio]
English abstract : [en]
OBJECTIVE: Despite recent changes in clinical research methodology, many challenges remain in drug development methodology.
RESULTS: Advances in molecular biology and cancer treatments have changed the clinical research ...
Show more >OBJECTIVE: Despite recent changes in clinical research methodology, many challenges remain in drug development methodology. RESULTS: Advances in molecular biology and cancer treatments have changed the clinical research landscape. Thus, we moved from empirical clinical oncology to molecular and immunological therapeutic approaches. Along with this move, adapted dose-limiting toxicities definitions, endpoints, and dose escalation methods have been proposed. Moreover, the classical frontier between phase I, phase II, and phase III has become unclear in particular for immunological approaches. So, investigators are facing major challenges in drug development methodology. CONCLUSIONS: We propose to individualize clinical research using innovative approaches to significantly improve patient outcomes and targeting what is considered unmet need. Integrating high level of translational research and performing well designed biomarker studies with great potential for clinical practice are of utmost importance. This could be performed within new models of clinical research networks and by building a strong collaboration between academic, cooperative groups, on-site investigators, and pharma.Show less >
Show more >OBJECTIVE: Despite recent changes in clinical research methodology, many challenges remain in drug development methodology. RESULTS: Advances in molecular biology and cancer treatments have changed the clinical research landscape. Thus, we moved from empirical clinical oncology to molecular and immunological therapeutic approaches. Along with this move, adapted dose-limiting toxicities definitions, endpoints, and dose escalation methods have been proposed. Moreover, the classical frontier between phase I, phase II, and phase III has become unclear in particular for immunological approaches. So, investigators are facing major challenges in drug development methodology. CONCLUSIONS: We propose to individualize clinical research using innovative approaches to significantly improve patient outcomes and targeting what is considered unmet need. Integrating high level of translational research and performing well designed biomarker studies with great potential for clinical practice are of utmost importance. This could be performed within new models of clinical research networks and by building a strong collaboration between academic, cooperative groups, on-site investigators, and pharma.Show less >
Language :
Anglais
Audience :
Internationale
Popular science :
Non
Administrative institution(s) :
CHU Lille
Université de Lille
Université de Lille
Submission date :
2019-12-09T18:17:04Z
2024-12-18T10:45:59Z
2024-12-18T10:45:59Z