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

ABSTRACT: To determine the accuracy of the recruitment status listed on ClinicalTrials.gov as compared with the actual trial status.Cross-sectional analysis.Random sample of interventional phase 2-4 clinical trials registered between 2010 and 2012 on ClinicalTrials.gov.For 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.Among 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recruitment status was updated.At present, registry recruitment status information in ClinicalTrials.gov is often outdated or wrong.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.

SUBMITTER: Jones CW

PROVIDER: S-EPMC5652524 | biostudies-other | 2017 Oct

REPOSITORIES: biostudies-other

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

Jones Christopher W CW Safferman Michelle R MR Adams Amanda C AC Platts-Mills Timothy F TF

BMJ open 20171011 10

<h4>Objectives</h4>To determine the accuracy of the recruitment status listed on ClinicalTrials.gov as compared with the actual trial status.<h4>Design</h4>Cross-sectional analysis.<h4>Setting</h4>Random sample of interventional phase 2-4 clinical trials registered between 2010 and 2012 on ClinicalTrials.gov.<h4>Primary outcome measure</h4>For each trial which was listed within ClinicalTrials.gov as ongoing, two investigators performed a comprehensive literature search for evidence that the tria ...[more]

PMID: 29025842

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Project description:BackgroundSuboptimal health status (SHS) among urban residents is commonplace in China. However, factors influencing SHS have not been thoroughly explored, especially with regard to the effects of internal factors (e.g., personality and health awareness) on SHS.MethodsA cross-sectional study was conducted with a nationally representative sample of 5460 Chinese urban residents..SHS was measured using the Suboptimal Health Mesurement Scale Version 1.0. Demographic information, and information pertaining to lifestyle behaviors, environmental factors, and internal factors were abtained through a questionnaire. The associations between demographic information, lifestyle behaviors, environmental factors, internal factors and SHS were assessed using logistic regression.ResultsOf the 5460 participants (with a mean age of 41.56 ± 16.14 years), 2640 (48.4 %) were men. Out of 36 variables, 23 were significantly associated with SHS: age (odds ratio [OR]: 1.014), an education level of high school/junior college (OR: 1.443) , marital status (OR: 1.899), area of registered permanent residence (OR: 0.767), monthly household income (p < 0.001) , exposure to second-hand smoke (p = 0.001), alcohol drinking (OR: 1.284), bad eating habits (OR: 1.717), not sleeping before 11 p.m. every day (p = 0.002), spending time online more than five hours a day (OR: 1.526), having a good relationship with parents during one's growth period (OR: 0.602), living with good quality air (OR:0.817), living in not crowded conditions (OR:0.636), having a harmonious neighborhood (OR:0.775), having adequate fitness facilities (OR:0.783), one's health being affected by two-child policy (OR: 1.468) and medical policies (OR: 1.265) , high adverse quotient (OR: 0.488), many (≥3 kinds) interests and hobbies (OR: 0.617), mature and steady personality traits (OR: 0.469) , a high attention to one's health (OR: 0.833), and effective health promotion induced by leading a leisurely lifestyle (OR: 0.466) were significantly associated with SHS.ConclusionsAll these variables were included demographic information, lifestyle behaviors, environmental factors and internal factors. Our study supports the benefits of controlling both internal and external factors in preventing suboptimal health.

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

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

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