Discrepancies between ClinicalTrials.gov recruitment status and actual trial status: a cross-sectional analysis

ObjectivesTo determine the accuracy of the recruitment status listed on ClinicalTrials.gov as compared with the actual trial status.DesignCross-sectional analysis.SettingRandom sample of interventional phase 2–4 clinical trials registered between 2010 and 2012 on ClinicalTrials.gov.Primary outcome measureFor each trial which was listed within ClinicalTrials.gov as ongoing, two investigators performed a comprehensive literature search for evidence that the trial had actually been completed. For each trial listed as completed or terminated early by ClinicalTrials.gov, we compared the date that the trial was actually concluded with the date the registry was updated to reflect the study’s conclusion status.ResultsAmong the 405 included trials, 92 had a registry status indicating that study activity was either ongoing or the recruitment status was unknown. Of these, published results were available for 34 (37%). Among the 313 concluded trials, the median delay between study completion and a registry update reflecting that the study had ended was 141 days (IQR 48–419), with delays of over 1 year present for 29%. In total, 125 trials (31%) either had a listed recruitment status which was incorrect or had a delay of more than 1 year between the time the study was concluded and the time the registry recruitment status was updated.ConclusionsAt present, registry recruitment status information in ClinicalTrials.gov is often outdated or wrong. This inaccuracy has implications for the ability of researchers to identify completed trials and accurately characterise all available medical knowledge on a given subject.

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Results dissemination of registered clinical trials across Polish academic institutions: a cross-sectional analysis

BMJ Open ◽

10.1136/bmjopen-2019-034666 ◽

2020 ◽

Vol 10 (1) ◽

pp. e034666 ◽

Cited By ~ 2

Author(s):

Karolina Strzebonska ◽

Mateusz T Wasylewski ◽

Lucja Zaborowska ◽

Nico Riedel ◽

Susanne Wieschowski ◽

...

Keyword(s):

Clinical Trials ◽

Outcome Measure ◽

Cross Sectional Study ◽

Timely Manner ◽

Cross Sectional ◽

Journal Publication ◽

Cross Sectional Analysis ◽

Academic Medical ◽

Study Completion ◽

Sectional Analysis

ObjectivesTo establish the rates of publication and reporting of results for interventional clinical trials across Polish academic medical centres (AMCs) completed between 2009 and 2013. We aim also to compare the publication and reporting success between adult and paediatric trials.DesignCross-sectional study.SettingAMCs in Poland.ParticipantsAMCs with interventional trials registered on ClinicalTrials.gov.Main outcome measureResults reporting on ClinicalTrials.gov and publishing via journal publication.ResultsWe identified 305 interventional clinical trials registered on ClinicalTrials.gov, completed between 2009 and 2013 and affiliated with at least one AMC. Overall, 243 of the 305 trials (79.7%) had been published as articles or posted their summary results on ClinicalTrials.gov. Results were posted within a year of study completion and/or published within 2 years of study completion for 131 trials (43.0%). Dissemination by both posting and publishing results in a timely manner was achieved by four trials (1.3%).ConclusionsOur cross-sectional analysis revealed that Polish AMCs fail to meet the expectation for timely disseminating the findings of all interventional clinical trials. Delayed dissemination and non-dissemination of trial results negatively affects decisions in healthcare.

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Lingual Frenulum Phenotypes in Brazilian Infants With Congenital Zika Syndrome

The Cleft Palate-Craniofacial Journal ◽

10.1177/1055665618766999 ◽

2018 ◽

Vol 55 (10) ◽

pp. 1391-1398 ◽

Cited By ~ 7

Author(s):

Cristiane Sá Roriz Fonteles ◽

Erlane Marques Ribeiro ◽

Marinisi Sales Aragão Santos ◽

Rebeka Ferreira Pequeno Leite ◽

Gabryela Sales Assunção ◽

...

Keyword(s):

Primary Outcome ◽

Outcome Measure ◽

Task Force ◽

Descriptive Study ◽

Primary Outcome Measure ◽

Cross Sectional ◽

Speech Language Pathologist ◽

Congenital Zika Syndrome ◽

Pediatric Dentists ◽

Multidisciplinary Group

Objective: The present study aimed to evaluate lingual frenulum in children affected by congenital Zika syndrome (CZS) and to analyze the association of lingual frenulum phenotypes with other variables. Design: This present work had a cross-sectional, descriptive study design. Setting: This study was carried out in Fortaleza (Brazil). The health professionals provided tertiary level of care. Data collection occurred during a multidisciplinary task force for evaluating infants affected by CZS in December 2 to 3, 2016. Patients: Fifty-four patients with CZS (1-12 months old; 32 girls and 22 boys) were recruited from a population of 70 infants. Interventions: A multidisciplinary group comprised of speech-language pathologist/audiologists and pediatric dentists evaluated all patients through an intraoral examination and a specific tongue maneuver protocol for infants. Main Outcome Measures: Lingual frenulum visibility was the primary outcome measure. Before initiating the study, we hypothesized that children with CZS had an absent lingual frenulum. Results: Lingual frenula were visible in 34 (63%) infants, whereas in 20 (37%) infants lingual frenula visibility required a specific maneuver to retract the tongue. Six of 20 infants presented posteriorly positioned lingual frenula that were visible after maneuver. Lingual frenula were covered by mucous tissue in 14 infants. Presence of posterior frenulum was associated with dysphagia ( P = 0.038). However, the presence of dysphagia in a multivariate model did not associate with the presence of a posterior lingual frenulum ( P = .069) or neurologic symptoms ( P = .056). Conclusion: Children with CZS showed predominance of a posterior lingual frenula covered by an overlapping curtain-like mucous membrane.

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Who is at risk of occupational Q fever: new insights from a multi-profession cross-sectional study

BMJ Open ◽

10.1136/bmjopen-2019-030088 ◽

2020 ◽

Vol 10 (2) ◽

pp. e030088 ◽

Cited By ~ 2

Author(s):

Tanja Groten ◽

Karola Kuenzer ◽

Udo Moog ◽

Beate Hermann ◽

Katrin Maier ◽

...

Keyword(s):

At Risk ◽

Primary Outcome ◽

Outcome Measure ◽

Q Fever ◽

Cross Sectional Study ◽

Primary Outcome Measure ◽

Sectional Study ◽

Cross Sectional ◽

Seroprevalence Data ◽

Regular Contact

ObjectivesQ fever is a zoonosis caused by the bacteriumCoxiella burnetii. It is recognised as an occupational hazard for individuals who are in regular contact with animal birth products. Data from the literature are not comparable because different serological assays perform very differently in detecting past infections. It is therefore essential to choose the right assay for obtaining reliable data of seroprevalence. Obstetricians are another profession potentially at risk of Q fever. They can be infected from birth products of women with Q fever during pregnancy. There is little data, however, for Q fever in this occupational group. Our study therefore had two purposes. The first was to obtain reliable seroprevalence data for occupational groups in regular contact with animal birth products by using an assay with proven excellent sensitivity and specificity for detecting past infections. The second purpose was to obtain primary data for obstetricians.DesignWe carried out a cross-sectional study.SettingThe study included shepherds, cattle farmers, veterinarians and obstetricians from Thuringia.Participants77 shepherds, 74 veterinarians, 14 cattle farmers, 17 office employees and 68 obstetricians participated. The control group consisted of 92 blood donors.Primary outcome measureThe primary outcome measure wasC. burnetiiphase II specific IgG. The assay used was evaluated for this purpose in a previous study.ResultsOf the 250 blood samples we analysed, the very highest seroprevalences (64%–77%) occurred in individuals with frequent animal contact. There were no significant differences between shepherds, cattle farmers and veterinarians. The seroprevalence in people working in administration was lower but still significantly greater than the control. No obstetricians or midwives tested positive.ConclusionsShepherds, cattle farmers and veterinarians have a high risk ofC. burnetiiinfection. However, our study clearly proves that there was no increased risk for people working in an obstetric department.

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Postmarketing commitments for novel drugs and biologics approved by the US Food and Drug Administration: a cross-sectional analysis

10.1101/447185 ◽

2018 ◽

Author(s):

Joshua D Wallach ◽

Anita T Luxkaranayagam ◽

Sanket S Dhruva ◽

Jennifer E Miller ◽

Joseph S Ross

Keyword(s):

Clinical Trials ◽

Public Reporting ◽

Cross Sectional ◽

Cross Sectional Analysis ◽

Reporting Requirements ◽

Fda Approval ◽

Novel Drugs ◽

Status Information ◽

Sectional Analysis

AbstractBackgroundPostmarketing commitments are clinical studies that drug sponsors agree to conduct at the time of FDA approval, but which are not required by statute or regulation. The objective of this study was to determine the characteristics, completion, and dissemination of postmarketing commitments agreed upon by sponsors at first FDA approval.MethodsWe performed a cross-sectional analysis of postmarketing commitments for new drugs and biologics approved 2009-2012. Using public FDA documents, ClinicalTrials.gov, and Scopus, we determined postmarketing commitments and their characteristics known at the time of FDA approval; number of postmarketing commitments subject to reporting requirements, for which FDA is required to make study status information available to the public (“506B studies”), and their statuses; and rates of registration and results reporting on ClinicalTrials.gov and publication in peer-reviewed journals for all clinical trials, with follow-up through July 2018.ResultsAmong 110 novel drugs and biologics approved by the FDA between 2009-2012, 61 (55.5%) had at least one postmarketing commitment at the time of first approval. Of 331 total postmarketing commitments, 271 (81.9%) were non-human subjects research, predominantly chemistry, manufacturing, and controls studies; 49 (14.8%) were clinical trials (33 new and 16 ongoing trials for which follow-up results would be reported). Study descriptions for the new clinical trials often lacked information to establish study design features. Of the 89 (26.9%) 506B studies subject to public reporting requirements, of which 42 were clinical trials, 59 (66.3%) did not have an up-to-date status provided by FDA. Nearly all new clinical trials (28 of 31, 90.3%) were registered on ClinicalTrials.gov; of the 23 registered trials that were completed or terminated, 22 (95.7%) had reported results. Only half (14 of 29, 48.3%) of completed or terminated clinical trials, registered or unregistered, were published in peer-reviewed journals. Conclusions: The majority of postmarketing commitments agreed to by sponsors at the time of FDA approval for novel drugs and biologics approved between 2009-2012 were chemistry, manufacturing, and controls studies. While only 15% were clinical trials, these trials were nearly always registered with reported results on ClinicalTrials.gov. However, despite FDA public reporting requirements, up-to-date study status information was often unavailable for 506B studies.

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Delays in reporting and publishing trial results during pandemics: cross sectional analysis of 2009 H1N1, 2014 Ebola, and 2016 Zika clinical trials

BMC Medical Research Methodology ◽

10.1186/s12874-021-01324-8 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Christopher W. Jones ◽

Amanda C. Adams ◽

Elizabeth Murphy ◽

Rachel P. King ◽

Benjamin Saracco ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

H1n1 Influenza ◽

World Health ◽

Trial Registry ◽

Cross Sectional ◽

Cross Sectional Analysis ◽

2009 H1n1 ◽

Study Completion ◽

Sectional Analysis

Abstract Background Pandemic events often trigger a surge of clinical trial activity aimed at rapidly evaluating therapeutic or preventative interventions. Ensuring rapid public access to the complete and unbiased trial record is particularly critical for pandemic research given the urgent associated public health needs. The World Health Organization (WHO) established standards requiring posting of results to a registry within 12 months of trial completion and publication in a peer reviewed journal within 24 months of completion, though compliance with these requirements among pandemic trials is unknown. Methods This cross-sectional analysis characterizes availability of results in trial registries and publications among registered trials performed during the 2009 H1N1 influenza, 2014 Ebola, and 2016 Zika pandemics. We searched trial registries to identify clinical trials testing interventions related to these pandemics, and determined the time elapsed between trial completion and availability of results in the registry. We also performed a comprehensive search of MEDLINE via PubMed, Google Scholar, and EMBASE to identify corresponding peer reviewed publications. The primary outcome was the compliance with either of the WHO’s established standards for sharing clinical trial results. Secondary outcomes included compliance with both standards, and assessing the time elapsed between trial completion and public availability of results. Results Three hundred thirty-three trials met eligibility criteria, including 261 H1N1 influenza trials, 60 Ebola trials, and 12 Zika trials. Of these, 139 (42%) either had results available in the trial registry within 12 months of study completion or had results available in a peer-reviewed publication within 24 months. Five trials (2%) met both standards. No results were available in either a registry or publication for 59 trials (18%). Among trials with registered results, a median of 42 months (IQR 16–76 months) elapsed between trial completion and results posting. For published trials, the median elapsed time between completion and publication was 21 months (IQR 9–34 months). Results were available within 24 months of study completion in either the trial registry or a peer reviewed publication for 166 trials (50%). Conclusions Very few trials performed during prior pandemic events met established standards for the timely public dissemination of trial results.

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Individual factors influencing public's perceptions about the importance of COVID-19 immunity certificates: a cross-sectional online questionnaire survey in the UK

10.1101/2021.11.12.21266256 ◽

2021 ◽

Author(s):

Corina Elena Niculaescu ◽

Isabel Karen Sassoon ◽

Irma Cecilia Landa-Avila ◽

Ozlem Colak ◽

Gyuchan Thomas Jun ◽

...

Keyword(s):

Primary Outcome ◽

Outcome Measure ◽

Service Providers ◽

Primary Outcome Measure ◽

Individual Factors ◽

Cross Sectional ◽

Independent Variables ◽

Factors Influencing ◽

Perceived Importance ◽

The Uk

Objectives: To assess what were the main individual factors influencing people's perception of the importance of using COVID-19 immunity certificates. Design: Cross-sectional online survey. Setting: Nationally representative survey in the UK, conducted on the 3rd of August 2021. Participants: Responses from 534 participants, aged 18 and older, residents of the UK. Interventions: This was a cross-sectional survey and each participant replied to the same set of questions. Primary outcome measure and independent variables: The primary outcome measure (dependent variable) was the participants' perceived importance of using immunity certificates, computed as an index of six items. The following individual drivers were used as the independent variables: a) personal beliefs about COVID-19 (using constructs adapted from the Health Belief Model), b) personal views on vaccination, c) willingness to share immunity status with service providers, and d) variables related to respondents' lifestyle and socio-demographic characteristics. Results: Perceived importance of immunity certificates was higher among respondents who felt that contracting COVID-19 would have a severe negative impact on their health (β=0.2564, p=0.0000) and felt safer if vaccinated (β=0.1552, p=0.0000). The prospect of future economic recovery positively influenced perceived importance of immunity certificates. Respondents who were employed or self-employed (β=-0.2412, p=0.0010), or experienced an increase in income after the COVID-19 pandemic (β=-0.1287, p=0.0020) perceived less important the use of immunity certificates compared to those who were unemployed or had retired or those who had experienced reduction in their income during the pandemic. Conclusions: The findings of our survey suggest that more vulnerable members in our society (unemployed or retired and those believing that COVID-19 would have a severe impact on their health) and people who experienced a reduction in income during the pandemic perceived the severity of not using immunity certificates in their daily life as higher.

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Government’s subsidisation policy and utilisation of smoking cessation treatments: a population-based cross-sectional study in Taiwan

BMJ Open ◽

10.1136/bmjopen-2020-040424 ◽

2021 ◽

Vol 11 (1) ◽

pp. e040424

Author(s):

Sheng-Kuang Wang ◽

Chi-Wen Kao ◽

Hui-Wan Chuang ◽

Yi-Kai Tseng ◽

Wan-Chun Chen ◽

...

Keyword(s):

Smoking Cessation ◽

Primary Outcome ◽

Outcome Measure ◽

Primary Outcome Measure ◽

Cross Sectional ◽

Quit Smoking ◽

Combined Use ◽

Heavy Smokers ◽

Cessation Clinic ◽

Smoking Cessation Clinic

ObjectivesThis study examined the associations between the Second-Generation Cessation Payment Scheme (SCPS) and the use of smoking cessation treatments. Furthermore, these associations were compared between light and heavy smokers in Taiwan.DesignThis study had a cross-sectional design.SettingData were obtained from the Taiwan Adult Smoking Behaviour Surveillance System 2010–2011 and 2013–2014; data for each year consisted of a nationally representative sample of adults aged 18 years and older.ParticipantsCurrent smokers who had either quit or made a serious attempt to quit smoking were selected for the analysis.Primary outcome measureThe primary outcome measure was the use of a smoking cessation clinic or pharmacy in a twice daily to quit smoking.ResultsAccording to multivariate analysis, the SCPS was positively associated with the combined use of a smoking cessation clinic and a pharmacy (OR=3.947; 95% CI: 1.359 to 11.463) when individual-level predictors (gender, age, education level, marital status, monthly household income, daily cigarette consumption, smoking status and self-reported health) were controlled. Heavy smokers showed a signiﬁcant increase in the sole use of a pharmacy (OR=1.676; 95% CI: 1.094 to 2.569) and combined use of a smoking cessation clinic and pharmacy (OR=8.984; 95% CI: 1.914 to 42.173) after the SCPS was introduced. In addition, when related factors were controlled, the use of smoking cessation services was more frequent among heavy smokers than light smokers, including any treatment (OR=1.594; 95% CI: 1.308 to 1.942), a smoking cessation clinic (OR=1.539; 95% CI: 1.232 to 1.922), a pharmacy (OR=1.632; 95% CI: 1.157 to 2.302) and the combination of a smoking cessation clinic and pharmacy (OR=4.608; 95% CI: 1.331 to 15.949) .ConclusionsThe SCPS subsidisation policy increased the use of smoking cessation treatments, particularly among heavy smokers.

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