TY - JOUR
T1 - European regulatory use and impact of subgroup evaluation in marketing authorisation applications
AU - Tanniou, Julien
AU - Teerenstra, Steven
AU - Hassan, Sagal
AU - Elferink, Andre
AU - van der Tweel, Ingeborg
AU - Gispen-de Wied, Christine
AU - Roes, Kit C.B.
N1 - Publisher Copyright:
© 2017 The Authors
PY - 2017/12
Y1 - 2017/12
N2 - Marketing authorisation application dossiers relating to medicinal products containing new active substances and evaluated by the European Medicines Agency (EMA) over the period 2012-2015 were examined. Major objections and other concerns relating to efficacy and safety of the day 80 assessment reports were reviewed. Overall, approved products have more subgroup concerns than nonapproved products, which seems to be a consistent pattern. Subgroup analyses are mainly assessed to have the insurance that subgroups of patients that might lack a positive benefit: risk ratio will not be wrongly included in the approved treatment indication.
AB - Marketing authorisation application dossiers relating to medicinal products containing new active substances and evaluated by the European Medicines Agency (EMA) over the period 2012-2015 were examined. Major objections and other concerns relating to efficacy and safety of the day 80 assessment reports were reviewed. Overall, approved products have more subgroup concerns than nonapproved products, which seems to be a consistent pattern. Subgroup analyses are mainly assessed to have the insurance that subgroups of patients that might lack a positive benefit: risk ratio will not be wrongly included in the approved treatment indication.
UR - http://www.scopus.com/inward/record.url?scp=85030162366&partnerID=8YFLogxK
U2 - 10.1016/j.drudis.2017.09.012
DO - 10.1016/j.drudis.2017.09.012
M3 - Article
C2 - 28943304
AN - SCOPUS:85030162366
SN - 1359-6446
VL - 22
SP - 1760
EP - 1764
JO - Drug Discovery Today
JF - Drug Discovery Today
IS - 12
ER -