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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Expert consensus recommendations on the use of randomized clinical trials for drug approval in psychiatry- comparing trial designs
European Neuropsychopharmacology, Volume 60, Year 2022
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Description
The use of randomized clinical trials, in particular placebo-controlled trials, for drug approval, is the subject of long-standing debate in the scientific community and beyond. This study offers consensus recommendations from clinical and academic experts to guide the selection of clinical trial design in psychiatry. Forty-one highly cited clinical psychiatrists and/or researchers participated in a Delphi survey. Consensus statements were developed based on the findings of a published, peer-reviewed systematic review. Participants evaluated statements in two survey rounds, following the Delphi method. The expert panel achieved consensus on 7 of 21 recommendations regarding the use of randomized clinical trials. The endorsed recommendations were: (i) Results from placebo-controlled trials are the most reliable and (ii) are necessary despite the growing placebo-effect; (iii) it is ethical to enroll patients in placebo-arms when established treatment is available, if there is no evidence of increased health risk; (iv) There is a need to approve new drugs with the same efficacy as existing treatments, but with different side-effect profiles; (v) Non-inferiority trials incur an increased risk of approving ineffective medications; (vi) The risk of approving an ineffective drug justifies trial designs that incur higher costs, and (vii) superiority trials incur the risk of rejecting potentially efficacious treatments. The endorsed recommendations inform the choice of trial-design appropriate for approval of psychopharmacological drugs. The recommendations strongly support the use of randomized clinical trials in general, and the use of placebo-controlled trials in particular. © 2022 Elsevier B.V. and ECNP
Authors & Co-Authors
Lerer, Bernard
Unknown Affiliation
Goodwin, Guy M.
United Kingdom, Oxford
University of Oxford
Berk, Michael
Australia, Geelong
Barwon Health
Meyer-Lindenberg, Andreas S.
Germany, Heidelberg
Universität Heidelberg
Yatham, Lakshmi N.
Canada, Vancouver
The University of British Columbia
Goldberg, Joseph F.
United States, New York
Icahn School of Medicine at Mount Sinai
Malhi, Gin Singh
Australia, Sydney
The University of Sydney
El-Mallakh, Rif Shody
Unknown Affiliation
Licht, Rasmus Wentzer
Denmark, Aalborg
Aalborg University
Young, Allan H.
United Kingdom, London
South London and Maudsley Nhs Foundation Trust
United States, Boston
Harvard Medical School
Kapczinski, Flávio Pereira
Canada, Hamilton
Mcmaster University
Hagin, Michal
Israel, Bat Yam
Abarbanel Mental Health Center
Torrent, Carla
Spain, Barcelona
Institut D'investigacions Biomèdiques August pi I Sunyer - Idibaps
Serretti, Alessandro
Italy, Bologna
Alma Mater Studiorum Università Di Bologna
Martínez-Àran, Anabel
Spain, Barcelona
Institut D'investigacions Biomèdiques August pi I Sunyer - Idibaps
Strejilevich, Sergio Adrián
Unknown Affiliation
Rybakowski, Janusz K.
Poland, Poznan
Poznan University of Medical Sciences
Pinto, Ana González
Spain, Vitoria-gasteiz
Instituto de Investigación Sanitaria Bioaraba
Azorin, Jean Michel
France, Marseille
Hôpital Sainte Marguerite
López-Jaramillo, Carlos Alberto
Colombia, Medellin
Universidad de Antioquia
Frey, B. N.
United States, New York
Icahn School of Medicine at Mount Sinai
Canada, Hamilton
St. Joseph's Healthcare Hamilton
Nierenberg, Andrew Alan
United States, Boston
Massachusetts General Hospital
Parker, Gordon B.
Australia, Sydney
Unsw Sydney
Cohen, Adam Fa
Netherlands, Leiden
Leids Universitair Medisch Centrum
Perugi, Giulio
Italy, Pisa
Università Di Pisa
Vieta, Eduard
Spain, Barcelona
Institut D'investigacions Biomèdiques August pi I Sunyer - Idibaps
Statistics
Citations: 5
Authors: 26
Affiliations: 32
Identifiers
Doi:
10.1016/j.euroneuro.2022.05.002
ISSN:
0924977X
Study Design
Randomised Control Trial
Cross Sectional Study
Study Approach
Quantitative
Systematic review