TY  - CHAP
U1  - Buchbeitrag
A1  - Hinder, Markus
A1  - Schuhmacher, Alexander
ED  - Schuhmacher, Alexander
T1  - The evolution of clinical development : from technical success to clinical value creation
T2  - Value creation in the pharmaceutical industry : the critical path to innovation
N2  - 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.
KW  - clinical development
KW  - clinical trials
KW  - phase 2 and phase 3
KW  - marketing approval
KW  - endpoints
KW  - safety and efficacy
KW  - dose finding
KW  - evidence-based medicine
Y1  - 2016
SN  - 978-3-527-69340-5
SB  - 978-3-527-69340-5
U6  - https://doi.org/10.1002/9783527693405.ch10
DO  - https://doi.org/10.1002/9783527693405.ch10
SP  - 203
EP  - 223
S1  - 21
PB  - Wiley
CY  - Weinheim
ER  -