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Discontinuation and non‐publication of heart failure randomized controlled trials: a call to publish all trial results
- Source :
- ESC Heart Failure, Vol 8, Iss 1, Pp 16-25 (2021), ESC Heart Failure, ESC heart failure, vol 8, iss 1
- Publication Year :
- 2021
- Publisher :
- Wiley, 2021.
-
Abstract
- Author(s): Khan, Muhammad Shahzeb; Shahid, Izza; Asad, Nava; Greene, Stephen J; Khan, Safi U; Doukky, Rami; Metra, Marco; Anker, Stefan D; Filippatos, Gerasimos S; Fonarow, Gregg C; Butler, Javed | Abstract: AimsDiscontinuation or non-publication of trials may hinder scientific progress and violates the commitment made to research participants. We sought to identify the prevalence of discontinuation and non-publication of heart failure (HF) clinical trials.Methods and resultsWe conducted a cross-sectional search of ClinicalTrials.gov to identify all completed and discontinued HF clinical trials. We limited our search to only include trials that were completed by 31 December 2017. Trials were investigated to identify reasons for discontinuation. Informative termination was defined as trial termination due to safety or efficacy concerns. Data pertaining to the trial phase, funding, intervention, enrolment, and trial completion date were extracted for each trial. A total of 572 trials were included. Of these, 21% (nn=n118) were discontinued before completion. Patient accrual was the most frequently cited reason (nn=n42; 36%) for trial discontinuation, followed by informative termination (nn=n16; 14%) and funding (nn=n14; 12%). Overall, 24n780 patients were enrolled in trials that were terminated. Of trials that were completed and not terminated, nearly one-third (nn=n131/454; 29%) were not published. Seventy-nine (24%) trials were published within 12nmonths, 192 (59%) within 24nmonths, and 252 (78%) trials within 36nmonths.ConclusionsDiscontinuation and non-publication of HF trials is common. This raises ethical concerns towards participants who volunteer for research and are exposed to potential risks, inconvenience, and discomfort without furthering scientific progress.
- Subjects :
- medicine.medical_specialty
lcsh:Diseases of the circulatory (Cardiovascular) system
Heart failure
Discontinuation
030204 cardiovascular system & hematology
Cardiorespiratory Medicine and Haematology
Shahid
law.invention
03 medical and health sciences
0302 clinical medicine
Clinical trials
Randomized controlled trial
law
Non-publication
Original Research Articles
Medicine
Humans
030212 general & internal medicine
Original Research Article
Randomized Controlled Trials as Topic
Enrolment
Non‐publication
business.industry
Trial Phase
medicine.disease
Clinical trial
Patient accrual
Cross-Sectional Studies
lcsh:RC666-701
Ethical concerns
Physical therapy
Cardiology and Cardiovascular Medicine
business
Subjects
Details
- Language :
- English
- ISSN :
- 20555822
- Volume :
- 8
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- ESC Heart Failure
- Accession number :
- edsair.doi.dedup.....dad2b6995d922065f7610ff46a68a6b4