Cargando…
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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
---|---|
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 |
_version_ | 1783605149781983232 |
---|---|
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. |
format | Online Article Text |
id | pubmed-7610178 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | F1000 Research Limited |
record_format | MEDLINE/PubMed |
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 |
work_keys_str_mv | AT maguirebrittanyj baselineresultsofalivingsystematicreviewforcovid19clinicaltrialregistrations AT mcleanalistairrd baselineresultsofalivingsystematicreviewforcovid19clinicaltrialregistrations AT rashansumayyah baselineresultsofalivingsystematicreviewforcovid19clinicaltrialregistrations AT antonioemiliasitsofe baselineresultsofalivingsystematicreviewforcovid19clinicaltrialregistrations AT bagariajayshree baselineresultsofalivingsystematicreviewforcovid19clinicaltrialregistrations AT bentounsizineb baselineresultsofalivingsystematicreviewforcovid19clinicaltrialregistrations AT brackmatthew baselineresultsofalivingsystematicreviewforcovid19clinicaltrialregistrations AT caldwellfiona baselineresultsofalivingsystematicreviewforcovid19clinicaltrialregistrations AT carraraverenailona baselineresultsofalivingsystematicreviewforcovid19clinicaltrialregistrations AT citarellabarbarawanjiru baselineresultsofalivingsystematicreviewforcovid19clinicaltrialregistrations AT dahalprabin baselineresultsofalivingsystematicreviewforcovid19clinicaltrialregistrations AT fetehvitalisfambombi baselineresultsofalivingsystematicreviewforcovid19clinicaltrialregistrations AT hbguerinmarius baselineresultsofalivingsystematicreviewforcovid19clinicaltrialregistrations AT kennonkalynn baselineresultsofalivingsystematicreviewforcovid19clinicaltrialregistrations AT biltonlahautkathinka baselineresultsofalivingsystematicreviewforcovid19clinicaltrialregistrations AT makukageraldjamberi baselineresultsofalivingsystematicreviewforcovid19clinicaltrialregistrations AT nguroland baselineresultsofalivingsystematicreviewforcovid19clinicaltrialregistrations AT obiesiesopuruchukwu baselineresultsofalivingsystematicreviewforcovid19clinicaltrialregistrations AT richmondcaitlin baselineresultsofalivingsystematicreviewforcovid19clinicaltrialregistrations AT singhphulgendasauman baselineresultsofalivingsystematicreviewforcovid19clinicaltrialregistrations AT strudwicksamantha baselineresultsofalivingsystematicreviewforcovid19clinicaltrialregistrations AT tyrrellcarinasb baselineresultsofalivingsystematicreviewforcovid19clinicaltrialregistrations AT schwinnaustin baselineresultsofalivingsystematicreviewforcovid19clinicaltrialregistrations AT kingdavid baselineresultsofalivingsystematicreviewforcovid19clinicaltrialregistrations AT newtonpauln baselineresultsofalivingsystematicreviewforcovid19clinicaltrialregistrations AT pricericn baselineresultsofalivingsystematicreviewforcovid19clinicaltrialregistrations AT mersonlaura baselineresultsofalivingsystematicreviewforcovid19clinicaltrialregistrations AT stepniewskakasia baselineresultsofalivingsystematicreviewforcovid19clinicaltrialregistrations AT guerinphilippej baselineresultsofalivingsystematicreviewforcovid19clinicaltrialregistrations |