Estimating the effect of COVID-19 on trial design characteristics: a registered report

Smith, James; DeVito, Nicholas J; Lee, Hopin; Tiplady, Catherine; Abhari, Roxanna E.; Kartsonaki, Christiana

doi:10.1098/rsos.201543

Cited by 1 publication

(1 citation statement)

References 59 publications

(77 reference statements)

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“…We defined these as late-phase (i.e., ≥ Phase 2), randomized trials enrolling at least 100 participants. Trial characteristics were extracted from the ICTRP dataset using previously validated automated methods [ 19 ].…”

Section: Methodsmentioning

confidence: 99%

Dissemination of Registered COVID-19 Clinical Trials (DIRECCT): a cross-sectional study

Salholz-Hillel,

Pugh-Jones,

Hildebrand

et al. 2023

BMC Med

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Background The results of clinical trials should be completely and rapidly reported during public health emergencies such as COVID-19. This study aimed to examine when, and where, the results of COVID-19 clinical trials were disseminated throughout the first 18 months of the pandemic. Methods Clinical trials for COVID-19 treatment or prevention were identified from the WHO ICTRP database. All interventional trials with a registered completion date ≤ 30 June 2021 were included. Trial results, published as preprints, journal articles, or registry results, were located using automated and manual techniques across PubMed, Google Scholar, Google, EuropePMC, CORD-19, the Cochrane COVID-19 Study Register, and clinical trial registries. Our main analysis reports the rate of dissemination overall and per route, and the time from registered completion to results using Kaplan–Meier methods, with additional subgroup and sensitivity analyses reported. Results Overall, 1643 trials with completion dates ranging from 46 to 561 days prior to the start of results searches were included. The cumulative probability of reporting was 12.5% at 3 months from completion, 21.6% at 6 months, and 32.8% at 12 months. Trial results were most commonly disseminated in journals (n = 278 trials, 69.2%); preprints were available for 194 trials (48.3%), 86 (44.3%) of which converted to a full journal article. Trials completed earlier in the pandemic were reported more rapidly than those later in the pandemic, and those involving ivermectin were more rapidly reported than other common interventions. Results were robust to various sensitivity analyses except when considering only trials in a “completed” status on the registry, which substantially increased reporting rates. Poor trial registry data on completion status and dates limits the precision of estimates. Conclusions COVID-19 trials saw marginal increases in reporting rates compared to standard practice; most registered trials failed to meet even the 12-month non-pandemic standard. Preprints were common, complementing journal publication; however, registries were underutilized for rapid reporting. Maintaining registry data enables accurate representation of clinical research; failing to do so undermines these registries’ use for public accountability and analysis. Addressing rapid reporting and registry data quality must be emphasized at global, national, and institutional levels.

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Section: Methodsmentioning

confidence: 99%