Evidence map›Paper›PMID 37402556›Full record

Observational studyCMAJ open

Time required to initiate a clinical trial in Canada at the onset of the COVID-19 pandemic: an observational research-in-motion study.

Koren Teo, Robert A Fowler, Neill K J Adhikari, Asgar Rishu, Jennifer L Y Tsang, Alexandra Binnie, Srinivas Murthy, Canadian Critical Care Trials Group

Open access · diamondAbstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in CMAJ open. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
4.6field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Article
  3. Factors influencing community intensive care unit research participation: a qualitative descriptive study.Canadian journal of anaesthesia = Journal canadien d'anesthesie · 2024
    Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 1 institution in 1 country.

Koren TeoCanadian Forces Health Services Group (Teo), Ottawa, Ont.; Temerty Faculty of Medicine (Teo), University of Toronto; Department of Critical Care Medicine (Fowler, Adhikari, Rishu), Sunnybrook Health Sciences Centre; Interdepartmental Division of Critical Care Medicine and Institute for Health Policy, Management and Evaluation (Fowler, Adhikari, Rishu), University of Toronto, Toronto, Ont.; Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Niagara Health (Tsang), St. Catharines, Ont.; Critical Care Department (Binnie), William Osler Health System, Etobicoke, Ont.; Faculty of Medicine (Murthy), University of British Columbia, Vancouver, BC koren.lui@mail.utoronto.ca.
Robert A FowlerCanadian Forces Health Services Group (Teo), Ottawa, Ont.; Temerty Faculty of Medicine (Teo), University of Toronto; Department of Critical Care Medicine (Fowler, Adhikari, Rishu), Sunnybrook Health Sciences Centre; Interdepartmental Division of Critical Care Medicine and Institute for Health Policy, Management and Evaluation (Fowler, Adhikari, Rishu), University of Toronto, Toronto, Ont.; Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Niagara Health (Tsang), St. Catharines, Ont.; Critical Care Department (Binnie), William Osler Health System, Etobicoke, Ont.; Faculty of Medicine (Murthy), University of British Columbia, Vancouver, BC.
Neill K J AdhikariCanadian Forces Health Services Group (Teo), Ottawa, Ont.; Temerty Faculty of Medicine (Teo), University of Toronto; Department of Critical Care Medicine (Fowler, Adhikari, Rishu), Sunnybrook Health Sciences Centre; Interdepartmental Division of Critical Care Medicine and Institute for Health Policy, Management and Evaluation (Fowler, Adhikari, Rishu), University of Toronto, Toronto, Ont.; Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Niagara Health (Tsang), St. Catharines, Ont.; Critical Care Department (Binnie), William Osler Health System, Etobicoke, Ont.; Faculty of Medicine (Murthy), University of British Columbia, Vancouver, BC.
Asgar RishuCanadian Forces Health Services Group (Teo), Ottawa, Ont.; Temerty Faculty of Medicine (Teo), University of Toronto; Department of Critical Care Medicine (Fowler, Adhikari, Rishu), Sunnybrook Health Sciences Centre; Interdepartmental Division of Critical Care Medicine and Institute for Health Policy, Management and Evaluation (Fowler, Adhikari, Rishu), University of Toronto, Toronto, Ont.; Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Niagara Health (Tsang), St. Catharines, Ont.; Critical Care Department (Binnie), William Osler Health System, Etobicoke, Ont.; Faculty of Medicine (Murthy), University of British Columbia, Vancouver, BC.
Jennifer L Y TsangCanadian Forces Health Services Group (Teo), Ottawa, Ont.; Temerty Faculty of Medicine (Teo), University of Toronto; Department of Critical Care Medicine (Fowler, Adhikari, Rishu), Sunnybrook Health Sciences Centre; Interdepartmental Division of Critical Care Medicine and Institute for Health Policy, Management and Evaluation (Fowler, Adhikari, Rishu), University of Toronto, Toronto, Ont.; Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Niagara Health (Tsang), St. Catharines, Ont.; Critical Care Department (Binnie), William Osler Health System, Etobicoke, Ont.; Faculty of Medicine (Murthy), University of British Columbia, Vancouver, BC.
Alexandra BinnieCanadian Forces Health Services Group (Teo), Ottawa, Ont.; Temerty Faculty of Medicine (Teo), University of Toronto; Department of Critical Care Medicine (Fowler, Adhikari, Rishu), Sunnybrook Health Sciences Centre; Interdepartmental Division of Critical Care Medicine and Institute for Health Policy, Management and Evaluation (Fowler, Adhikari, Rishu), University of Toronto, Toronto, Ont.; Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Niagara Health (Tsang), St. Catharines, Ont.; Critical Care Department (Binnie), William Osler Health System, Etobicoke, Ont.; Faculty of Medicine (Murthy), University of British Columbia, Vancouver, BC.
Srinivas MurthyCanadian Forces Health Services Group (Teo), Ottawa, Ont.; Temerty Faculty of Medicine (Teo), University of Toronto; Department of Critical Care Medicine (Fowler, Adhikari, Rishu), Sunnybrook Health Sciences Centre; Interdepartmental Division of Critical Care Medicine and Institute for Health Policy, Management and Evaluation (Fowler, Adhikari, Rishu), University of Toronto, Toronto, Ont.; Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Niagara Health (Tsang), St. Catharines, Ont.; Critical Care Department (Binnie), William Osler Health System, Etobicoke, Ont.; Faculty of Medicine (Murthy), University of British Columbia, Vancouver, BC.
Canadian Critical Care Trials Group
Sunnybrook Health Science Centre · CA

Funding

CIHR WST-171496
6 · The paper itself

Abstract

backgroundRandomized controlled trials (RCTs) provide essential evidence to inform practice, but the many necessary steps result in lengthy times to initiation, which is problematic in the case of rapidly emerging infections such as COVID-19. This study aimed to describe the start-up timelines for the Canadian Treatments for COVID-19 (CATCO) RCT.

methodsWe surveyed hospitals participating in CATCO and ethics submission sites using a structured data abstraction form. We measured durations from protocol receipt to site activation and to first patient enrolment, as well as durations of administrative processes, including research ethics board (REB) approval, contract execution and lead times between approvals to site activation.

resultsAll 48 hospitals (26 academic, 22 community) and 4 ethics submission sites responded. The median time from protocol receipt to trial initiation was 111 days (interquartile range [IQR] 39-189 d, range 15-412 d). The median time between protocol receipt and REB submission was 41 days (IQR 10-56 d, range 4-195 d), from REB submission to approval, 4.5 days (IQR 1-12 d, range 0-169 d), from REB approval to site activation, 35 days (IQR 22-103 d, range 0-169 d), from protocol receipt to contract submission, 42 days (IQR 20-51 d, range 4-237 d), from contract submission to full contract execution, 24 days (IQR 15-58 d, range 5-164 d) and from contract execution to site activation, 10 days (IQR 6-27 d, range 0-216 d). Processes took longer in community hospitals than in academic hospitals.

interpretationThe time required to initiate RCTs in Canada was lengthy and varied among sites. Adoption of template clinical trial agreements, greater harmonization or central coordination of ethics submissions, and long-term funding of platform trials that engage academic and community hospitals are potential solutions to improve trial start-up efficiency.

Indexed as

COVID-19CanadaHospitalsHumansTime Factors

Identifiers

PMID37402556
PMCPMC10325581
OpenAlexW4383101896

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.