Beyond the lessons learned from the COVID-19 pandemic: opportunities to optimize clinical trial implementation in oncology
| Autor: | L. Castelo-Branco, Florian Lordick, Susana Banerjee, Andrés Cervantes, Ahmad Awada, Solange Peters, Joaquin Mateo, Josep Tabernero, Jose Luis Perez-Gracia, G. Pentheroudakis, R. Giuliani, Giuseppe Curigliano |
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| Přispěvatelé: | Institut Català de la Salut, [Castelo-Branco L, Pentheroudakis G] Scientific and Medical Division, European Society for Medical Oncology (ESMO), Lugano, Switzerland. [Awada A] Head of the Oncology Medicine Department, Institut Jules Bordet, Université libre de Bruxelles, Belgium. [Perez-Gracia JL] Department of Oncology, Clinica Universidad de Navarra, Pamplona, Spain. [Mateo J] Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain. Vall d'Hebron Hospital Universitari, Barcelona, Spain. [Curigliano G] Istituto Europeo di Oncologia, IRCCS and University of Milano, Milano, Italy. [Tabernero J] Vall d'Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. UVic-UCC, Barcelona, Spain, Vall d'Hebron Barcelona Hospital Campus |
| Rok vydání: | 2021 |
| Předmět: |
Oncology
Cancer Research Telemedicine medicine.medical_specialty Oncologia media_common.quotation_subject Medical Oncology profesiones sanitarias::medicina::medicina interna::oncología médica [DISCIPLINAS Y OCUPACIONES] Quality of life (healthcare) características del estudio::estudio clínico::ensayo clínico [CARACTERÍSTICAS DE PUBLICACIONES] Study Characteristics::Clinical Study::Clinical Trial [PUBLICATION CHARACTERISTICS] Internal medicine Pandemic virosis::infecciones por virus ARN::infecciones por Nidovirales::infecciones por Coronaviridae::infecciones por Coronavirus [ENFERMEDADES] medicine Pandèmia de COVID-19 2020 Humans Quality (business) Health Occupations::Medicine::Internal Medicine::Medical Oncology [DISCIPLINES AND OCCUPATIONS] Pandemics media_common COVID-19 Pandemics/prevention & control SARS-CoV-2 Surrogate endpoint Virus Diseases::RNA Virus Infections::Nidovirales Infections::Coronaviridae Infections::Coronavirus Infections [DISEASES] World population Clinical trial Editorial Good clinical practice Business Assaigs clínics |
| Zdroj: | ESMO Open Scientia ESMO open, vol. 6, no. 5, pp. 100237 |
| ISSN: | 2059-7029 |
| Popis: | The COVID-19 pandemic affected millions of people globally with lasting effects on society, patients, investigators and health institutions. Clinical trials, our best tool to improve cancer treatment for patients through testing the clinical value of a new treatment, have been affected by the pandemic. The pandemic footprint represents both a risk of compromising development of new therapies and an opportunity to elicit discussion over a portfolio of broader reforms, applicable irrespective of pandemics, in order to improve the design and implementation of clinical trials in oncology. The administrative load should be reduced, without affecting the quality of research and principles of good clinical practice. Cancer centres are encouraged to adapt their research/operational structures to the requirements of molecular oncology and embrace novel trial designs. Technological and methodological leaps in telemedicine can convert physical to virtual visits while routine examinations may be performed in local institutions (co-research centres), maintaining adherence to good clinical and research practices. The adoption of broader inclusion criteria and clinically significant endpoints (survival, quality of life) should be promoted, co-existing with pathways for fast-track “conditional” drug approvals in areas of unmet need, based on surrogate endpoints that are linked to strict post-approval validation requirements. The utility of Real World Data as part of these validation requirements should be actively investigated. Lessons learnt from the SARS Cov2 pandemic can be developed in order to expand equitable access to clinical trials of a real world population, in a simplified and methodologically robust modus operandi, for the benefit of all our patients. |
| Databáze: | OpenAIRE |
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