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The evolution of clinical development : from technical success to clinical value creation

  • Clinical development is historically the phase in which a potential new medicine is being tested in phase 2 and phase 3 patient trials to demonstrate the new molecules' efficacy and safety to support the regulatory approval of drugs by health authorities. This relatively focused approach has been considerably expanded by a number of forces from within the pharmaceutical industry and equally important by changes in the healthcare systems. The need to identify the optimal patient population, showstoppers leading to discontinuation of clinical programs, the silent but constant removal of surrogate endpoints for registration, and the increased demand for real-life data which are used to demonstrate the patients' benefit and which have an ever-increasing role for pricing and reimbursement negotiations are today an integral part of this phase. This chapter will review both the nuts and bolts of clinical development but also recent developments in this area which shape the environment and how the different players have reacted and what options might need to be explored in the future.

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Metadaten
Name:Schuhmacher, Alexander
DOI:https://doi.org/10.1002/9783527693405.ch10
ISBN:978-3-527-69340-5
Erschienen in:Value creation in the pharmaceutical industry : the critical path to innovation
Publisher:Wiley-VCH
Place of publication:Weinheim
Editor:Alexander Schuhmacher
Document Type:Part of a Book
Language:English
Year of Publication:2016
Tag:clinical development; clinical trials; dose finding; endpoints; evidence-based medicine; marketing approval; phase 2 and phase 3; safety and efficacy
Pagenumber:21
First Page:203
Last Page:223
Catalogue entry:Im Katalog der Hochschule Reutlingen ansehen
Dewey Decimal Classification:330 Wirtschaft
540 Chemie
Open Access:Nein
Licence (German):License Logo  Lizenzbedingungen Wiley