Facilitating access to new therapeutic options through clinical trials: the vision of a regulator to reconcile innovation and safety

Author:

Vignot S.ORCID,Martin M.,Albin N.,Schurtz C.,Chapel E.

Publisher

Elsevier BV

Subject

Oncology,Hematology

Reference10 articles.

1. ICH guideline S9 Nonclinical Evaluation for Anticancer Pharmaceuticals,2019

2. France investigates drug trial disaster;Casassus;Lancet,2016

3. Guideline on Strategies to Identify and Mitigate Risks for First-in-Human and Early Clinical Trials With Investigational Medicinal Products, 20 July 2017.https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-strategies-identify-mitigate-risks-first-human-early-clinical-trials-investigational_en.pdf (24 July 2019, date last accessed).

4. Cancer Multidisciplinary Team Meetings: evidence, Challenges, and the Role of Clinical Decision Support Technology;Patkar;Int J Breast Cancer,2011

5. Different Management Procedures for Category 1 Clinical Trials of Medications in France.https://www.ansm.sante.fr/var/ansm_site/storage/original/application/5261e19b576ef537db0ba8aa9f48892a.pdf (24 July 2019, date last accessed).

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