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

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.

Issues with reporting and interpretation of Khan et al. 2021.

A recent publication in BMC Infectious Diseases concerning the use of convalescent plasma for the treatment of COVID-19 had a number of major issues. This correspondence details specific instances of unclear reporting as well as major omissions when discussing the context of the trial. These render the study's findings and conclusions misleading.

Barriers and best practices to improving clinical trials transparency at UK public research institutions: A qualitative interview study.

OBJECTIVES: Since 2017, the UK government has made concerted efforts to ensure the dissemination of clinical trials conducted at public research institutions. This study aims to understand how stakeholders within these institutions responded to these pressures and modified internal policies and processes while identifying best practices and barriers to improved transparency practice. METHODS: Research governance and trial management staff from UK public research institutions (i.e., Universities and NHS Trusts) in England, Scotland and Wales participated in semi-structured interviews. Interviews were analysed using thematic analysis, aided by the framework method. RESULTS: Between November 2020 and July 2021, 14 individual participants were recruited from 11 different institutions. They worked in research governance, administration, and management. Almost universally, new policies and procedures have been established to ensure investigators are aware of, and supported in, fulfilling their transparency commitments, however challenges remain. Trials of medicinal products, as the most closely regulated research, consequently received the most attention. National professional networks aid in sharing knowledge and best practice within this community. CONCLUSIONS: Investment in the institutional governance of transparency is essential to achieving optimal transparency practices. Universities and hospitals share responsibility for ensuring research is performed and reported to regulatory standards. Facing political pressure, public research institutions in the UK have made efforts to improve their transparency practice which can provide key insights for similar efforts elsewhere.

Professional medical writing support and the quality, ethics and timeliness of clinical trial reporting: a systematic review.

BACKGROUND: Many authors choose to work with professional medical writers when reporting the results of clinical trials. We conducted a systematic review to examine the relationship between professional medical writing support (PMWS) and the quality, ethics and timeliness of publications reporting clinical trials. METHODS: Using terms related to 'medical writer' and 'observational study', we searched MEDLINE and Embase (no date limits), as well as abstracts and posters from meetings of the International Society for Medical Publication Professionals (ISMPP; 2014-2018). We also hand-searched the journals Medical Writing and The Write Stuff (2014-2018) and the bibliographies of studies identified in the electronic searches. We screened the results to identify studies that compared the quality, ethics and timeliness of clinical trial publications written with and without declared PMWS. RESULTS: Our searches identified 97 potentially relevant studies, of which 89 were excluded during screening and full paper review. The remaining eight studies compared 849 publications with PMWS with 2073 articles developed without such support. In these eight studies, PMWS was shown to be associated with increased adherence to Consolidated Standards of Reporting Trials (CONSORT) guidelines (in 3/3 studies in which this was assessed), publication in journals with an impact factor (one study), a higher quality of written English (one study), and a lower likelihood of reporting non-pre-specified outcomes (one study). PMWS was not associated with increased adherence to CONSORT for Abstracts guidelines (one study) or with the impact of published articles (mean number of citations per year, mean number of article views per year and Altmetric score; one study). In studies that assessed timeliness of publication, PMWS was associated with a reduced time from last patient visit in clinical trials to primary publication (one study), whereas time from submission to acceptance showed inconsistent results (two studies). CONCLUSIONS: This systematic review of eight observational studies suggests that PMWS is positively associated with measures of overall quality of reporting of clinical trials and may improve the timeliness of publication.

Assessing the adoption of clinical trial results summary disclosure to patients and the public.

Introduction: There is a broad global acknowledgment that the timely and effective communication of clinical trial results is not only essential to the development, diagnosis, and treatment of medical conditions but also meets an ethical obligation to inform patients and the public. Areas covered: At this time, less than 2% of all clinical trials completed or terminated within the past three years returned plain language summaries to study volunteers. This estimate is far below our forecast made 10 years ago when we evaluated a pilot effort to demonstrate a feasible and efficient process for communicating summary results to patients. At that time, we anticipated that research sponsors would embrace the obligation and in so doing would improve their relationship with and trust among their study volunteers and patient communities. This article discusses why adoption remains low and suggests that the absence of clear regulatory requirements and their enforcement are the primary cause. Expert opinion: The authors anticipate that the regulatory environment will tighten and that public, patient and patient advocate appetite and expectation for the disclosure of clinical trial results summaries in plain language will intensify during the next 18 months. These pressures will compel research sponsors to accelerate adoption.