Evidence map›Paper›PMID 37072360›Full record

ArticleBMJ open2023

Completion and publication of clinical trials in a cooperative group: a cohort study of trials of the Swiss Group for Clinical Cancer Research (SAKK).

Stefanie Hayoz, Benjamin Kasenda, Annina Lea Schenker, Christoph Kopp, Sämi Schär, Beat Thürlimann, Roger von Moos, Miklos Pless

Abstract read
In one paragraph

Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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, 1 synthesis or guideline pooled it.

  1. Time to publication for results of clinical trials.The Cochrane database of systematic reviews · 2024
    Pooled it
  2. Article
  3. 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.

Stefanie HayozStatistics, Competence Center of SAKK, Bern, Switzerland stefanie.hayoz@sakk.ch.ORCID 0000-0002-2265-6559
Benjamin KasendaMedical Oncology, University Hospital Basel, Basel, Switzerland.ORCID 0000-0003-0110-8585
Annina Lea SchenkerStatistics, Competence Center of SAKK, Bern, Switzerland.
Christoph KoppStatistics, Competence Center of SAKK, Bern, Switzerland.
Sämi SchärStatistics, Competence Center of SAKK, Bern, Switzerland.
Beat ThürlimannDepartment of Internal Medicine, Division Oncology-Haematology, Kantonsspital Sankt Gallen, Sankt Gallen, Switzerland.
Roger von MoosMedical Oncology/Haematology, Kantonsspital Graubünden, Chur, Switzerland.
Miklos PlessMedical Oncology, Kantonsspital Winterthur, Winterthur, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPremature trial discontinuation and non-publication of trial results are still major issues negatively affecting reliable evidence generation.

objectivesTo investigate trial completion and publication rate of cancer trials conducted within the Swiss Group for Clinical Cancer Research (SAKK).

designCohort study of clinical trials.

settingCohort of interventional cancer trials conducted in Switzerland with accrual closure between 1986 and 2021 identified from the SAKK trial management system. OUTCOMES: Premature trial discontinuation and publication in peer-reviewed journal.

resultsWe included 261 trials; median number of recruited patients was 150.5 (range 1-8028). Most trials (67.0%) were randomised. Overall, 76 of 261 (29.1%) trials were prematurely closed for accrual. The three main reasons for premature closure were insufficient accrual in 28 trials, followed by stopping for futility in 17 or efficacy in 8 trials. We included 240 trials for the publication status (21 excluded, because 8 still in follow-up, for 10 the primary completion date was less than a year ago and for 3 the manuscript was submitted, but to accepted yet). 216 of 240 (90.0%) were published as a full article, 14 were published in other formats, leading to an overall publication rate of 95.8%. The rate of premature discontinuation declined over time, with 34.2%, 27.8% and 23.5% in trials activated before 2000, between 2000 and 2009, and since 2010, respectively. We observed an increasing publication rate in peer-reviewed journals over time: 79.2% (closed before 2000), 95.7% (closed between 2000 and 2009) and 93.2% (closed after 2010).

conclusionInsufficient patient recruitment is still the major reason for premature trial discontinuation. SAKK has continuously improved its quality management of trial conduct over time leading to increased successful trial completion and publication. However, there is still room for improvement to increase the number of trials reaching their target sample size.

Indexed as

NeoplasmsCohort StudiesEthnicityHumansPatient SelectionResearch DesignClinical trialsHAEMATOLOGYONCOLOGY

Identifiers

PMID37072360
PMCPMC10124283

What OpenQuestion holds

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Registered trials

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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.