TY - JOUR
T1 - Baseline results of a living systematic review for COVID-19 clinical trial registrations
AU - Guérin, Philippe J.
AU - Maguire, Brittany J.
AU - McLean, Alistair R.D.
AU - Rashan, Sumayyah
AU - Antonio, Emilia Sitsofe
AU - Bagaria, Jayshree
AU - Bentounsi, Zineb
AU - Brack, Matthew
AU - Caldwell, Fiona
AU - Carrara, Verena Ilona
AU - Citarella, Barbara Wanjiru
AU - Dahal, Prabin
AU - Feteh, Vitalis Fambombi
AU - H.B. Guérin, Marius
AU - Kennon, Kalynn
AU - Bilton Lahaut, Kathinka
AU - Makuka, Gerald Jamberi
AU - Ngu, Roland
AU - Obiesie, Sopuruchukwu
AU - Richmond, Caitlin
AU - Singh-Phulgenda, Sauman
AU - Strudwick, Samantha
AU - Tyrrell, Carina S.B.
AU - Schwinn, Austin
AU - King, David
AU - Newton, Paul N.
AU - Price, Ric N.
AU - Merson, Laura
AU - Stepniewska, Kasia
PY - 2020/10
Y1 - 2020/10
N2 - 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.
AB - 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.
KW - Clinical trials
KW - Coronavirus
KW - COVID-19
KW - Emerging infections
KW - Living systematic review
KW - SARS2-CoV2
UR - http://www.scopus.com/inward/record.url?scp=85085474243&partnerID=8YFLogxK
U2 - 10.12688/wellcomeopenres.15933.1
DO - 10.12688/wellcomeopenres.15933.1
M3 - Review article
AN - SCOPUS:85085474243
SN - 2398-502X
VL - 5
SP - 1
EP - 26
JO - Wellcome Open Research
JF - Wellcome Open Research
M1 - 116
ER -
