Role of a research ethics committee in follow-up and publication of results
Abstract
Follow-up of clinical trials is a commitment rarely fulfilled by research ethics committees (RECs). We assessed the output of clinical trials submitted in 1997 to our REC, and talked to principal investigators, sponsors, contract research organisations, or a combination of these. During 1997, our REC reviewed 166 clinical trials, and approved 158. The recruitment rate was lower than expected in 45% (64/143) of all initiated clinical trials; 64% (92/143) were finished in accordance with protocol. 3 years after, the results of only 21% (26/123) of finished clinical trials were published in peer-reviewed journals, rising to 31% (38/123) if in-press articles were included. RECs should devote more effort and resources to assess public dissemination of results of clinical trials.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Difficulties in recruitment are common in clinical trials.
“However, difficulties in recruitment are common in clinical trials.309 310”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [310]
The citation lists haven’t been fetched yet
References 1 · Cited by 104
- Authors
- Pich, J., Carné, X., Arnaiz, J.-A., Gómez, B., Trilla, A., & Rodés, J.
- Affiliations
- Hospital Clínic de Barcelona (ES)
- Corresponding author
- Carné, Xavier
- ORCID
- Trilla, Antoni
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2003-03
- Volume
- 361
- Issue
- 9362
- Pages
- 1015-1016
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W1976366538
- Cited by
- 104
- References
- 1
- Citations by year
- 2025: 3 · 2024: 2 · 2023: 1 · 2022: 1 · 2021: 1 · 2020: 1 · 2019: 1 · 2018: 1 · 2017: 4 · 2016: 4 · 2015: 4 · 2014: 5 · 2013: 9 · 2012: 1
- FWCI
- 11.17
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Lancet (publishedVersion)
- PubMed (publishedVersion)
- DIGITAL.CSIC (Spanish National Research Council (CSIC)) (acceptedVersion)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
- Social Sciences › Safety Research › Academic integrity and plagiarism
- Keywords
- research ethics committees, clinical trials, trial follow-up, publication of trial results, research dissemination, trial recruitment, protocol adherence, principal investigators, sponsors, contract research organizations
- MeSH terms
- Clinical Trials as Topic, Humans, Periodicals as Topic, Publications, Ethics Committees, Research
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
