Holger Langhof1,2, William Wei Lim Chin2, Susanne Wieschowski2, Carole Federico3, Jonathan Kimmelman3, Daniel Strech1,2. 1. Charité - University Medicine Berlin, QUEST - Center for Transforming Biomedical Research, Berlin Institute of Health (BIH), Berlin, Germany. 2. Institute for History, Ethics and Philosophy of Medicine, Hannover Medical School (MHH), Hannover, Germany. 3. STREAM (Studies of Translation, Ethics and Medicine), Biomedical Ethics Unit, McGill University, Montreal, QC, Canada.
Abstract
BACKGROUND AND PURPOSE: Therapeutic area guidelines (TAGs) published by the EMA and the FDA offer guidance in planning the launch of a trial in a certain indication. We assessed and compared the guidance on preclinical efficacy of all available TAGs from EMA and FDA. EXPERIMENTAL APPROACH: EMA and FDA websites and databases were searched for all TAGs. A mixed deductive and inductive approach was applied to analyse and cluster content for preclinical efficacy. KEY RESULTS: A total of 114 EMA and 120 FDA TAGs were identified, covering 126 indications. Our core finding is that 75% of EMA TAGs and 58% from the FDA TAGs do not offer any guidance on preclinical efficacy. TAGs varied widely on the extent, nature and detail of guidance. CONCLUSIONS AND IMPLICATIONS: Guidance on preclinical efficacy in a consistent, comprehensive and explicit way that still allows for justified deviations is an important but neglected aspect of transparency for drug development. This transparency would help sponsors in designing preclinical studies and in negotiating more efficiently with regulators.
BACKGROUND AND PURPOSE: Therapeutic area guidelines (TAGs) published by the EMA and the FDA offer guidance in planning the launch of a trial in a certain indication. We assessed and compared the guidance on preclinical efficacy of all available TAGs from EMA and FDA. EXPERIMENTAL APPROACH: EMA and FDA websites and databases were searched for all TAGs. A mixed deductive and inductive approach was applied to analyse and cluster content for preclinical efficacy. KEY RESULTS: A total of 114 EMA and 120 FDA TAGs were identified, covering 126 indications. Our core finding is that 75% of EMA TAGs and 58% from the FDA TAGs do not offer any guidance on preclinical efficacy. TAGs varied widely on the extent, nature and detail of guidance. CONCLUSIONS AND IMPLICATIONS: Guidance on preclinical efficacy in a consistent, comprehensive and explicit way that still allows for justified deviations is an important but neglected aspect of transparency for drug development. This transparency would help sponsors in designing preclinical studies and in negotiating more efficiently with regulators.
Authors: Sean I Savitz; Michael Chopp; Robert Deans; Tom Carmichael; Donald Phinney; Larry Wechsler Journal: Stroke Date: 2011-01-27 Impact factor: 7.914
Authors: Beatriz Moreno; Carmen Espejo; Leyre Mestre; Margarita Suardiaz; Diego Clemente; Fernando de Castro; Óscar Fernández-Fernández; Xavier Montalban; Pablo Villoslada; Carmen Guaza Journal: Rev Neurol Date: 2012-01-16 Impact factor: 0.870
Authors: L García-Bonilla; A Rosell; G Torregrosa; J B Salom; E Alborch; M Gutiérrez; E Díez-Tejedor; R Martínez-Murillo; J Agulla; P Ramos-Cabrer; J Castillo; T Gasull; J Montaner Journal: Neurologia Date: 2010-10-20 Impact factor: 3.109
Authors: Marc Fisher; Giora Feuerstein; David W Howells; Patricia D Hurn; Thomas A Kent; Sean I Savitz; Eng H Lo Journal: Stroke Date: 2009-02-26 Impact factor: 7.914
Authors: Guilherme S Ferreira; Désirée H Veening-Griffioen; Wouter P C Boon; Ellen H M Moors; Christine C Gispen-de Wied; Huub Schellekens; Peter J K van Meer Journal: PLoS One Date: 2019-06-13 Impact factor: 3.240
Authors: Anna Skic; Iwona Puzio; Grzegorz Tymicki; Paweł Kołodziej; Marta Pawłowska-Olszewska; Kamil Skic; Karolina Beer-Lech; Marek Bieńko; Krzysztof Gołacki Journal: Materials (Basel) Date: 2022-01-03 Impact factor: 3.623