Journal of Epidemiology and Global Health

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Volume 5, Issue 4, December 2015, Pages 385 - 395

Role of patient-reported outcomes and other efficacy endpoints in the drug approval process in Europe (2008–2012)

Authors
Dipika Bansala, *, dipikabansal079@gmail.com, Anil Bhagata, anilbhagat05@gmail.com, Fabrizio Schifanob, f.schifano@herts.ac.uk, Kapil Gudalaa, kapil.gudala@gmail.com
aDepartment of Pharmacy Practice, National Institute of Pharmaceutical Science, Mohali, India
bClinical Pharmacology and Therapeutics, University of Hertfordshire, Hertfordshire, UK
*Corresponding author at: F-307, Department of Pharmacy Practice, National Institute of Pharmaceutical Science, Sec-67, Mohali, Punjab 160062, India. Tel.: +91 9872217542.
Corresponding Author
Received 1 August 2014, Revised 9 April 2015, Accepted 10 April 2015, Available Online 29 May 2015.
DOI
10.1016/j.jegh.2015.04.006How to use a DOI?
Keywords
European Medicines Agency; European Public Assessment Report; Patient reported outcomes; Health related quality of health
Abstract

The present study aimed at systematically reviewing the role and extent of patient-reported outcomes (PROs) usage within the package of scientific evidence considered for marketing authorization (MA). All regulatory information published by the European Medicines Agency (EMA) for products authorized between January 2008 and December 2012 and appearing in the European Public Assessment Report (EPAR) database was examined for efficacy endpoints. The endpoints here considered included: PROs, clinician reported outcomes (CROs), and laboratory reported outcomes (LROs). LROs were the most frequently reported endpoints. Out of the 180 products here selected, 99 (55%), 67 (37%), and 30 (17%), respectively, used LROs, CROs and PROs as primary endpoints (PEs). PROs as any endpoints were used in 82 (46%) products. Out of these, PROs were documented as PE in 30 (37%), with 27 (33%) products having used PROs both as primary and non-PEs. PRO usage was most frequently identified with nervous system and antineoplastic agents. During the study period, the use of all the three types of endpoints appeared to be static. Both the regulatory bodies and the industry should ensure complete and clear reporting of all endpoints used, including PROs, to improve transparency.

Copyright
© 2015 Ministry of Health, Saudi Arabia. Published by Elsevier Ltd.
Open Access
This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

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<Previous Article In Issue
Next Article In Issue>
Journal
Journal of Epidemiology and Global Health
Volume-Issue
5 - 4
Pages
385 - 395
Publication Date
2015/05/29
ISSN (Online)
2210-6014
ISSN (Print)
2210-6006
DOI
10.1016/j.jegh.2015.04.006How to use a DOI?
Copyright
© 2015 Ministry of Health, Saudi Arabia. Published by Elsevier Ltd.
Open Access
This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Cite this article

risenwbib
TY  - JOUR
AU  - Dipika Bansal
AU  - Anil Bhagat
AU  - Fabrizio Schifano
AU  - Kapil Gudala
PY  - 2015
DA  - 2015/05/29
TI  - Role of patient-reported outcomes and other efficacy endpoints in the drug approval process in Europe (2008–2012)
JO  - Journal of Epidemiology and Global Health
SP  - 385
EP  - 395
VL  - 5
IS  - 4
SN  - 2210-6014
UR  - https://doi.org/10.1016/j.jegh.2015.04.006
DO  - 10.1016/j.jegh.2015.04.006
ID  - Bansal2015
ER  -