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.

Result reporting and early discontinuation of sepsis trials registered on ClinicalTrials.gov.

OBJECTIVE: Sepsis is a leading cause of death from infectious disease or traumatic injury. The prevalence and predictor of results underreporting and early stop of sepsis clinical trials remain poorly studied. To fill the gap, we designed this study to characterize sepsis clinical trials registered on ClinicalTrials.gov, particularly to recognize features related to premature discontinuation and lack of results reporting. METHODS: We searched ClinicalTrials.gov to include interventional sepsis trials up to July 8, 2022. All structured data of the identified trials were extracted and reviewed. A descriptive analysis was conducted. Cox and logistic regression analyses were conducted to determine the significance of the association of trial characteristics with early termination and lack of results reporting. RESULTS: A total of 1654 records were identified, among which 1061 eligible trials were reserved. Results underreporting happened in 91.6% of these sepsis interventional trials. 12.0% were discontinued. Moreover, factors that led to the higher risk of discontinuation were the US-registered clinical research and the small sample size. The factor that contributed to results underreporting was non-US-registered clinical trials. CONCLUSION: The frequent discontinuation and underreporting of sepsis trials have highly impaired the progress of sepsis management and studies. Therefore, solutions to early discontinuation and improving the quality of results dissemination remain an urgent problem.

Study Protocol on Social Return on Investment (SROI) Project of the Surgical Waiting List Management System.

In Andalusia, the right to maximum waiting times for healthcare clashes with the available supply, leading to an increase in demand in the form of waiting lists. To address this situation, the activity of private centers has been created for certain diagnostic tests. The Social Return on Investment (SROI) model evaluates an intervention from an economic and stakeholder perspective. However, there are no studies on the suitability of waiting lists using SROI, which is why it is intended to be studied as a decision-making tool for the clinical and healthcare management of waiting lists. This research protocol is designed to determine the quality of life gained, with the EuroQol-5D-5L questionnaire, and its social assessment, with the specific survey of the SROI method, and, thus, analyze the social return on investment and determine the suitability of the intervention (diagnostic endoscopy activity arranged in a contracted center). After the study, we will know the economic (cost in public health centers and the incremental cost of extraordinary health resources), social (quality of life with health), and environmental scenarios of the concerted activity intervention in order to adjust waiting list times.

Utilization of sentiment analysis to assess and compare negative finding reporting in veterinary and human literature.

Publication bias and the decreased publication of trials with negative or non-significant results is a well-recognized problem in human and veterinary medical publications. These biases may present an incomplete picture of evidence-based clinical care and negatively impact medical practices. The purpose of this study was to utilize a novel sentiment analysis tool as a quantitative measure for assessing clinical trial reporting trends in human and veterinary medical literature. Abstracts from 177,617 clinical trials in human medical journals and 8684 in veterinary medical journals published in the PubMed database from 1995 to 2020. Abstracts were analyzed using the GAN-BioBERT sentiment classifier for both general trends and percentage of neutral/negative publications. Sentiment was defined on a - 1 (highly negative) to 1 (highly positive) scale. Human-based clinical trial publications were less likely to feature positive findings (OR 0.87, P < 0.001) and more likely to include neutral findings (OR 1.18, P < 0.001) relative to veterinary clinical trials. No difference was found in reporting of negative sentiment trials (OR 1.007, P = 0.83). In both groups, the published sentiment of clinical trials increased over time. Using sentiment analysis to evaluate large publication datasets and compare publication trends within and between groups, this study is significant in its detection of significant publication differences between human and veterinary medicine clinical trials and a continued unbalanced positive sentiment in the published literature. The implications of this unbiased reporting have important clinical and research implications that require consideration.

Results Reporting and Early Termination of Childhood Obesity Trials Registered on ClinicalTrials.gov.

Objective: Childhood obesity is one of the most severe challenges of public health in the twenty-first century and may increase the risk of various physical and psychological diseases in adulthood. The prevalence and predictors of unreported results and premature termination in pediatric obesity research are not clear. We aimed to characterize childhood obesity trials registered on ClinicalTrials.gov and identify features associated with early termination and lack of results reporting. Methods: Records were downloaded and screened for all childhood obesity trials from the inception of ClinicalTrials.gov to July 29, 2021. We performed descriptive analyses of characteristics, Cox regression for early termination, and logistic regression for lack of results reporting. Results: We identified 1,312 trials registered at ClinicalTrials.gov. Among clinicalTrials.gov registered childhood obesity-related intervention trials, trial unreported results were 88.5 and 4.3% of trials were prematurely terminated. Additionally, the factors that reduced the risk of unreported outcomes were US-registered clinical studies and drug intervention trials. Factors associated with a reduced risk of early termination are National Institutes of Health (NIH) or other federal agency funding and large trials. Conclusion: The problem of unreported results in clinical trials of childhood obesity is serious. Therefore, timely bulletin of the results and reasons for termination remain urgent aims for childhood obesity trials.

Current Status and Issues of Ethical Review for Surgical Research in Japanese University Hospitals.

INTRODUCTION: In clinical research, ethical review is required prior to conducting the research. A surgical procedure is a complex intervention with properties that make it more difficult to evaluate rigorously and monitor than drug treatments. This study aimed to clarify the current status and issues in the ethical review and monitoring of surgical research. METHODS: We developed a self-administered questionnaire on surgical ethical review. The questionnaire was distributed to university hospitals in Japan and collected from November 2018 to February 2019. The distributed questionnaire consisted of the reviewed items, items with difficulties, and important items on ethical review. Fisher's exact test or the chi-square test was used for analysis. RESULTS: The questionnaires from 39 medical university hospitals were completed with appropriate answers to all items. "Technical review" was conducted at a significantly lower proportion (n = 30/39, 76.9%, p = 0.002). "Evaluation of the progress and results" was also (n = 22/39, 56.4%, p < 0.001). University hospitals in which "technical aspects and ethical review" was regarded the most important and difficult were higher (n = 24/39, 61.5%; n = 26/39, 66.7%, respectively). Respondents considered not only items written in the study protocol but also those on monitoring or oversight of surgical research as difficult. CONCLUSIONS: Our findings suggest that it is necessary to improve the ethical review system and provide supports to conduct an appropriate review for surgical research, e.g., technical aspect review or study progress/result evaluation.

Race and ethnicity reporting for clinical trials in ClinicalTrials.gov and publications.

Inclusion and subsequent reporting of minority participants in clinical trials are critical for ensuring external validity and detecting differences among subgroups, however reports suggest that ongoing gaps persist. ClinicalTrials.gov began requiring the reporting of race/ethnicity information (if collected) during results submission for trials in April 2017. For this study, we downloaded and compared trial race/ethnicity information from ClinicalTrials.gov submitted before (N = 3540) and after (N = 3542) the requirement date. We found that 42.0% of pre-requirement trials compared to 91.4% of post-requirement trials reported race/ethnicity information in ClinicalTrials.gov; 8.6% of post-requirement trials indicated race/ethnicity information was not collected. Use of NIH/U.S. Office of Management and Budget (OMB) classification categories was slightly higher in the post-requirement (77.1%) compared to pre-requirement (72.8%) samples. Additionally, we examined two 10% random samples of post-requirement trials - one with customized race/ethnicity reporting in ClinicalTrials.gov and the other with corresponding results publications available in PubMed. In the first random sample, 95.9% of customized categories included race information and 52.7% included ethnicity information. In the other random sample, 33.1% had a corresponding results publication, of which 62.4% reported race/ethnicity information in the publication. Among trials without published race/ethnicity information, 90.0% reported race/ethnicity information on ClinicalTrials.gov. This analysis demonstrates that the requirement has advanced public availability of information on the inclusion of minorities in research, but that further work remains to systematically ensure collection and complete reporting of race/ethnicity information.

Overcoming non-compliance with clinical trial registration and results reporting: One Institution's approach.

ClinicalTrials.gov is a web-based resource which provides the general public, healthcare professionals, patients, and caregivers access to privately and publicly supported clinical trials and trial results. The web site is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH) (ClinicalTrials.gov Background, 2018). The penalties for non-compliance with the legal obligations under FDAAA 801 (Food and Drug Administration Amendments Act of 2007) and the NIH requirements for registering and reporting results on studies within certain timeframes can result in large monetary fines and the withholding of federal funds (ClinicalTrials.gov FDAAA 801 and the Final Rule, 2019). Years following, in 2016, the Final Rule expanded upon the requirement with additional data elements for both registration and result submission records in accordance of FDAAA 801 (ClinicalTrials.gov FDAAA 801 and the Final Rule, 2019). The Medical University of South Carolina (MUSC), along with the institution's Office of Clinical Research and Regulatory Knowledge & Support group, identified issues affecting their own compliance rate with FDAAA 801 and the NIH and implemented several processes to overcome these challenges. In short, these processes included hiring a designated full-time ClinicalTrials.gov coordinator, implementing a workflow that identifies trials early in the IRB approval process requiring registration (without effecting study start up timelines), assisting researchers when navigating the registration and results reporting process through one-on-one consultations, Lunch and Learns, and disseminating new training tools as they become available. Over the next 12 months the results of this approach demonstrated a marked increase to 98% overall compliance with these federal regulations which may provide valuable guidance for other institutions working toward improved compliance rates.

Parents of Pediatric Radiology Patients Prefer Timely Reporting and Discussing Results with Referring Providers.

RATIONALE AND OBJECTIVES: With the introduction of new communication channels, such as encrypted messaging and online electronic medical record patient portals, there are ever-increasing ways for patients and their families to access their medical information. While patient preferences regarding how they receive the results of their radiology examinations have been assessed in the adult population, there is limited data on parent preferences for pediatric radiology patients. MATERIALS AND METHODS: The aim of this study was to determine how the parents of pediatric radiology patients prefer to receive the results of their child's imaging studies. The study design was an institutional review board-approved anonymous voluntary survey distributed to parents in a pediatric radiology waiting room. RESULTS: Of the current possible ways to receive radiology results, most parents preferred to receive their child's radiology results from the referring doctor (65%). A minority of parents preferred to receive the results from a radiologist in-person (16%) or via the radiology report (16%). In multiple hypothetical scenarios, parents also preferred to receive radiology results from the referring doctor rather than the radiologist, with the single exception being when no subsequent appointment with the referring doctor was planned. When asked to prioritize the most important aspect of receiving radiology test results, most parents prefer having results available quickly (65%). CONCLUSION: This survey suggests that in the pediatric radiology realm, efforts toward timely reporting will likely have a greater impact on patient satisfaction than prioritizing more in-person radiologist-patient communication.

Clinical trial registration and reporting: a survey of academic organizations in the United States.

BACKGROUND: Many clinical trials conducted by academic organizations are not published, or are not published completely. Following the US Food and Drug Administration Amendments Act of 2007, "The Final Rule" (compliance date April 18, 2017) and a National Institutes of Health policy clarified and expanded trial registration and results reporting requirements. We sought to identify policies, procedures, and resources to support trial registration and reporting at academic organizations. METHODS: We conducted an online survey from November 21, 2016 to March 1, 2017, before organizations were expected to comply with The Final Rule. We included active Protocol Registration and Results System (PRS) accounts classified by ClinicalTrials.gov as a "University/Organization" in the USA. PRS administrators manage information on ClinicalTrials.gov. We invited one PRS administrator to complete the survey for each organization account, which was the unit of analysis. RESULTS: Eligible organization accounts (N = 783) included 47,701 records (e.g., studies) in August 2016. Participating organizations (366/783; 47%) included 40,351/47,701 (85%) records. Compared with other organizations, Clinical and Translational Science Award (CTSA) holders, cancer centers, and large organizations were more likely to participate. A minority of accounts have a registration (156/366; 43%) or results reporting policy (129/366; 35%). Of those with policies, 15/156 (11%) and 49/156 (35%) reported that trials must be registered before institutional review board approval is granted or before beginning enrollment, respectively. Few organizations use computer software to monitor compliance (68/366; 19%). One organization had penalized an investigator for non-compliance. Among the 287/366 (78%) accounts reporting that they allocate staff to fulfill ClinicalTrials.gov registration and reporting requirements, the median number of full-time equivalent staff is 0.08 (interquartile range = 0.02-0.25). Because of non-response and social desirability, this could be a "best case" scenario. CONCLUSIONS: Before the compliance date for The Final Rule, some academic organizations had policies and resources that facilitate clinical trial registration and reporting. Most organizations appear to be unprepared to meet the new requirements. Organizations could enact the following: adopt policies that require trial registration and reporting, allocate resources (e.g., staff, software) to support registration and reporting, and ensure there are consequences for investigators who do not follow standards for clinical research.

Reporting results of research involving human subjects: an ethical obligation.

Researchers have an ethical responsibility to report the results of research involving human subjects. Dissemination of results ensures that patient care is based on good science and that the field of medicine advances based on complete and accurate knowledge. However, current evidence suggests that publication is often neglected or substantially delayed, especially in the case of negative and inconclusive results. Researchers, editors and reviewers should value all high-quality research regardless of the conclusiveness of the results and ensure that all research involving human subjects is registered in a publicly accessible database.

Reporting Results of Research Involving Human Subjects: An Ethical Obligation

Researchers have an ethical responsibility to report the results of research involving human subjects. Dissemination of results ensures that patient care is based on good science and that the field of medicine advances based on complete and accurate knowledge. However, current evidence suggests that publication is often neglected or substantially delayed, especially in the case of negative and inconclusive results. Researchers, editors and reviewers should value all high-quality research regardless of the conclusiveness of the results and ensure that all research involving human subjects is registered in a publicly accessible database.