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Do protocols for new randomised trials take previous similar trials into account? Cohort study of contemporary trial protocols

OBJECTIVE: To investigate to what extent evidence from previous similar trials or systematic reviews was considered before conducting new trials. DESIGN: Cohort study of contemporary protocols for trials with ethical approval. METHODS: All protocols for randomised trials approved by the five ethical...

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Autores principales: Paludan-Müller, Asger Sand, Ogden, Michelle C, Marquardsen, Mikkel, Vive, Jonas, Jørgensen, Karsten Juhl, Gøtzsche, Peter Christian
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6858261/
https://www.ncbi.nlm.nih.gov/pubmed/31712328
http://dx.doi.org/10.1136/bmjopen-2018-026661
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author Paludan-Müller, Asger Sand
Ogden, Michelle C
Marquardsen, Mikkel
Vive, Jonas
Jørgensen, Karsten Juhl
Gøtzsche, Peter Christian
author_facet Paludan-Müller, Asger Sand
Ogden, Michelle C
Marquardsen, Mikkel
Vive, Jonas
Jørgensen, Karsten Juhl
Gøtzsche, Peter Christian
author_sort Paludan-Müller, Asger Sand
collection PubMed
description OBJECTIVE: To investigate to what extent evidence from previous similar trials or systematic reviews was considered before conducting new trials. DESIGN: Cohort study of contemporary protocols for trials with ethical approval. METHODS: All protocols for randomised trials approved by the five ethical committees in Denmark between January 2012 and March 2013 were screened for eligibility. Included protocols were read in full to determine whether a systematic search had been conducted and references were checked to evaluate whether trial rationale and design could be challenged for not adequately considering previous evidence. To investigate whether protocols cited relevant trials, we used simple search strategies that could easily be conducted by researchers without experience with literature searches. RESULTS: Sixty-seven protocols were included. Only two (3%) of the protocols explicitly stated to have conducted a literature search and only one (1%) provided information that allowed the search to be replicated. Eleven (16%) of the protocols described trials where we found the information insufficient to judge if the trial was ethically justified, either due to a comparator that was not supported by the presented evidence (six protocols), because they did not present a rationale for conducting the trial (two protocols), or for both reasons (three protocols). For eight (12%) of the protocols, our search identified trials that could have been relevant to cite as justification. CONCLUSIONS: While most protocols seem to adequately consider existing evidence, a substantial minority of trials might lack a sufficient evidence base. Very few trials seemed to have been based on a literature search which makes it impossible to know whether all relevant previous trials had been considered. Rules for ethical approval should include requirements for systematic literature searches to ensure that research participants are not exposed to sub-optimal treatments or unnecessary harms as well as to reduce research waste.
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spelling pubmed-68582612019-12-03 Do protocols for new randomised trials take previous similar trials into account? Cohort study of contemporary trial protocols Paludan-Müller, Asger Sand Ogden, Michelle C Marquardsen, Mikkel Vive, Jonas Jørgensen, Karsten Juhl Gøtzsche, Peter Christian BMJ Open Ethics OBJECTIVE: To investigate to what extent evidence from previous similar trials or systematic reviews was considered before conducting new trials. DESIGN: Cohort study of contemporary protocols for trials with ethical approval. METHODS: All protocols for randomised trials approved by the five ethical committees in Denmark between January 2012 and March 2013 were screened for eligibility. Included protocols were read in full to determine whether a systematic search had been conducted and references were checked to evaluate whether trial rationale and design could be challenged for not adequately considering previous evidence. To investigate whether protocols cited relevant trials, we used simple search strategies that could easily be conducted by researchers without experience with literature searches. RESULTS: Sixty-seven protocols were included. Only two (3%) of the protocols explicitly stated to have conducted a literature search and only one (1%) provided information that allowed the search to be replicated. Eleven (16%) of the protocols described trials where we found the information insufficient to judge if the trial was ethically justified, either due to a comparator that was not supported by the presented evidence (six protocols), because they did not present a rationale for conducting the trial (two protocols), or for both reasons (three protocols). For eight (12%) of the protocols, our search identified trials that could have been relevant to cite as justification. CONCLUSIONS: While most protocols seem to adequately consider existing evidence, a substantial minority of trials might lack a sufficient evidence base. Very few trials seemed to have been based on a literature search which makes it impossible to know whether all relevant previous trials had been considered. Rules for ethical approval should include requirements for systematic literature searches to ensure that research participants are not exposed to sub-optimal treatments or unnecessary harms as well as to reduce research waste. BMJ Publishing Group 2019-11-10 /pmc/articles/PMC6858261/ /pubmed/31712328 http://dx.doi.org/10.1136/bmjopen-2018-026661 Text en © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Ethics
Paludan-Müller, Asger Sand
Ogden, Michelle C
Marquardsen, Mikkel
Vive, Jonas
Jørgensen, Karsten Juhl
Gøtzsche, Peter Christian
Do protocols for new randomised trials take previous similar trials into account? Cohort study of contemporary trial protocols
title Do protocols for new randomised trials take previous similar trials into account? Cohort study of contemporary trial protocols
title_full Do protocols for new randomised trials take previous similar trials into account? Cohort study of contemporary trial protocols
title_fullStr Do protocols for new randomised trials take previous similar trials into account? Cohort study of contemporary trial protocols
title_full_unstemmed Do protocols for new randomised trials take previous similar trials into account? Cohort study of contemporary trial protocols
title_short Do protocols for new randomised trials take previous similar trials into account? Cohort study of contemporary trial protocols
title_sort do protocols for new randomised trials take previous similar trials into account? cohort study of contemporary trial protocols
topic Ethics
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6858261/
https://www.ncbi.nlm.nih.gov/pubmed/31712328
http://dx.doi.org/10.1136/bmjopen-2018-026661
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