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Baseline results of a living systematic review for COVID-19 clinical trial registrations

Background: Since the coronavirus disease 2019 (COVID-19) outbreak was first reported in December 2019, many independent trials have been planned that aim to answer similar questions. Tools allowing researchers to review studies already underway can facilitate collaboration, cooperation and harmonis...

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Autores principales: Maguire, Brittany J., McLean, Alistair R.D., Rashan, Sumayyah, Antonio, Emilia Sitsofe, Bagaria, Jayshree, Bentounsi, Zineb, Brack, Matthew, Caldwell, Fiona, Carrara, Verena Ilona, Citarella, Barbara Wanjiru, Dahal, Prabin, Feteh, Vitalis Fambombi, H.B. Guérin, Marius, Kennon, Kalynn, Bilton Lahaut, Kathinka, Makuka, Gerald Jamberi, Ngu, Roland, Obiesie, Sopuruchukwu, Richmond, Caitlin, Singh-Phulgenda, Sauman, Strudwick, Samantha, Tyrrell, Carina S.B., Schwinn, Austin, King, David, Newton, Paul N., Price, Ric N., Merson, Laura, Stepniewska, Kasia, Guérin, Philippe J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: F1000 Research Limited 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7610178/
https://www.ncbi.nlm.nih.gov/pubmed/33154979
http://dx.doi.org/10.12688/wellcomeopenres.15933.1
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author Maguire, Brittany J.
McLean, Alistair R.D.
Rashan, Sumayyah
Antonio, Emilia Sitsofe
Bagaria, Jayshree
Bentounsi, Zineb
Brack, Matthew
Caldwell, Fiona
Carrara, Verena Ilona
Citarella, Barbara Wanjiru
Dahal, Prabin
Feteh, Vitalis Fambombi
H.B. Guérin, Marius
Kennon, Kalynn
Bilton Lahaut, Kathinka
Makuka, Gerald Jamberi
Ngu, Roland
Obiesie, Sopuruchukwu
Richmond, Caitlin
Singh-Phulgenda, Sauman
Strudwick, Samantha
Tyrrell, Carina S.B.
Schwinn, Austin
King, David
Newton, Paul N.
Price, Ric N.
Merson, Laura
Stepniewska, Kasia
Guérin, Philippe J.
author_facet Maguire, Brittany J.
McLean, Alistair R.D.
Rashan, Sumayyah
Antonio, Emilia Sitsofe
Bagaria, Jayshree
Bentounsi, Zineb
Brack, Matthew
Caldwell, Fiona
Carrara, Verena Ilona
Citarella, Barbara Wanjiru
Dahal, Prabin
Feteh, Vitalis Fambombi
H.B. Guérin, Marius
Kennon, Kalynn
Bilton Lahaut, Kathinka
Makuka, Gerald Jamberi
Ngu, Roland
Obiesie, Sopuruchukwu
Richmond, Caitlin
Singh-Phulgenda, Sauman
Strudwick, Samantha
Tyrrell, Carina S.B.
Schwinn, Austin
King, David
Newton, Paul N.
Price, Ric N.
Merson, Laura
Stepniewska, Kasia
Guérin, Philippe J.
author_sort Maguire, Brittany J.
collection PubMed
description Background: Since the coronavirus disease 2019 (COVID-19) outbreak was first reported in December 2019, many independent trials have been planned that aim to answer similar questions. Tools allowing researchers to review studies already underway can facilitate collaboration, cooperation and harmonisation. The Infectious Diseases Data Observatory (IDDO) has undertaken a living systematic review (LSR) to provide an open, accessible and frequently updated resource summarising characteristics of COVID-19 study registrations. Methods: Review of all eligible trial records identified by systematic searches as of 3 April 2020 and initial synthesis of clinical study characteristics were conducted. In partnership with Exaptive, an open access, cloud-based knowledge graph has been created using the results.  Results: There were 728 study registrations which met eligibility criteria and were still active. Median (25 (th), 75 (th) percentile) sample size was 130 (60, 400) for all studies and 134 (70, 300) for RCTs. Eight lower middle and low income countries were represented among the planned recruitment sites. Overall 109 pharmacological interventions or advanced therapy medicinal products covering 23 drug categories were studied. Majority (57%, 62/109) of them were planned only in one study arm, either alone or in combination with other interventions. There were 49 distinct combinations studied with 90% (44/49) of them administered in only one or two study arms. The data and interactive platform are available at https://iddo.cognitive.city/. Conclusions:  Baseline review highlighted that the majority of investigations in the first three months of the outbreak were small studies with unique treatment arms, likely to be unpowered to provide solid evidence.  The continued work of this LSR will allow a more dependable overview of interventions tested, predict the likely strength of evidence generated, allow fast and informative filtering of relevant trials for specific user groups and provide the rapid guidance needed by investigators and funders to avoid duplication of efforts.
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spelling pubmed-76101782020-11-04 Baseline results of a living systematic review for COVID-19 clinical trial registrations Maguire, Brittany J. McLean, Alistair R.D. Rashan, Sumayyah Antonio, Emilia Sitsofe Bagaria, Jayshree Bentounsi, Zineb Brack, Matthew Caldwell, Fiona Carrara, Verena Ilona Citarella, Barbara Wanjiru Dahal, Prabin Feteh, Vitalis Fambombi H.B. Guérin, Marius Kennon, Kalynn Bilton Lahaut, Kathinka Makuka, Gerald Jamberi Ngu, Roland Obiesie, Sopuruchukwu Richmond, Caitlin Singh-Phulgenda, Sauman Strudwick, Samantha Tyrrell, Carina S.B. Schwinn, Austin King, David Newton, Paul N. Price, Ric N. Merson, Laura Stepniewska, Kasia Guérin, Philippe J. Wellcome Open Res Systematic Review Background: Since the coronavirus disease 2019 (COVID-19) outbreak was first reported in December 2019, many independent trials have been planned that aim to answer similar questions. Tools allowing researchers to review studies already underway can facilitate collaboration, cooperation and harmonisation. The Infectious Diseases Data Observatory (IDDO) has undertaken a living systematic review (LSR) to provide an open, accessible and frequently updated resource summarising characteristics of COVID-19 study registrations. Methods: Review of all eligible trial records identified by systematic searches as of 3 April 2020 and initial synthesis of clinical study characteristics were conducted. In partnership with Exaptive, an open access, cloud-based knowledge graph has been created using the results.  Results: There were 728 study registrations which met eligibility criteria and were still active. Median (25 (th), 75 (th) percentile) sample size was 130 (60, 400) for all studies and 134 (70, 300) for RCTs. Eight lower middle and low income countries were represented among the planned recruitment sites. Overall 109 pharmacological interventions or advanced therapy medicinal products covering 23 drug categories were studied. Majority (57%, 62/109) of them were planned only in one study arm, either alone or in combination with other interventions. There were 49 distinct combinations studied with 90% (44/49) of them administered in only one or two study arms. The data and interactive platform are available at https://iddo.cognitive.city/. Conclusions:  Baseline review highlighted that the majority of investigations in the first three months of the outbreak were small studies with unique treatment arms, likely to be unpowered to provide solid evidence.  The continued work of this LSR will allow a more dependable overview of interventions tested, predict the likely strength of evidence generated, allow fast and informative filtering of relevant trials for specific user groups and provide the rapid guidance needed by investigators and funders to avoid duplication of efforts. F1000 Research Limited 2020-06-02 /pmc/articles/PMC7610178/ /pubmed/33154979 http://dx.doi.org/10.12688/wellcomeopenres.15933.1 Text en Copyright: © 2020 Maguire BJ et al. http://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Systematic Review
Maguire, Brittany J.
McLean, Alistair R.D.
Rashan, Sumayyah
Antonio, Emilia Sitsofe
Bagaria, Jayshree
Bentounsi, Zineb
Brack, Matthew
Caldwell, Fiona
Carrara, Verena Ilona
Citarella, Barbara Wanjiru
Dahal, Prabin
Feteh, Vitalis Fambombi
H.B. Guérin, Marius
Kennon, Kalynn
Bilton Lahaut, Kathinka
Makuka, Gerald Jamberi
Ngu, Roland
Obiesie, Sopuruchukwu
Richmond, Caitlin
Singh-Phulgenda, Sauman
Strudwick, Samantha
Tyrrell, Carina S.B.
Schwinn, Austin
King, David
Newton, Paul N.
Price, Ric N.
Merson, Laura
Stepniewska, Kasia
Guérin, Philippe J.
Baseline results of a living systematic review for COVID-19 clinical trial registrations
title Baseline results of a living systematic review for COVID-19 clinical trial registrations
title_full Baseline results of a living systematic review for COVID-19 clinical trial registrations
title_fullStr Baseline results of a living systematic review for COVID-19 clinical trial registrations
title_full_unstemmed Baseline results of a living systematic review for COVID-19 clinical trial registrations
title_short Baseline results of a living systematic review for COVID-19 clinical trial registrations
title_sort baseline results of a living systematic review for covid-19 clinical trial registrations
topic Systematic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7610178/
https://www.ncbi.nlm.nih.gov/pubmed/33154979
http://dx.doi.org/10.12688/wellcomeopenres.15933.1
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