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Differences in reporting serious adverse events in industry sponsored clinical trial registries and journal articles on antidepressant and antipsychotic drugs: a cross-sectional study.

ABSTRACT: To examine the degree of concordance in reporting serious adverse events (SAEs) from antidepressant and antipsychotic drug trials among journal articles and clinical trial summaries, and to categorise types of discrepancies.Cross-sectional study of summaries of all antidepressant and antipsychotic trials included in an online trial registry and their first associated stand-alone journal articles.Clinicalstudyresults.org, sponsored by Pharmaceutical Research and Manufacturers of America; clinicaltrials.gov, administered by the US National Institutes of Health.3 coders extracted data on the numbers and types of SAEs.244 trial summaries for six antidepressant and antipsychotic drugs were retrieved, 142 (58.2%) listing an associated article. Of 1608 SAEs in drug-treated participants according to trial summaries, 694 (43.2%) did not appear in associated articles. Nearly 60% of SAEs counted in articles and 41% in trial summaries had no description. Most cases of death (62.3%) and suicide (53.3%) were not reported in articles. Half or more of the 142 pairs were discordant in reporting the number (49.3%) or description (67.6%) of SAEs. These discrepancies resulted from journal articles' (1) omission of complete SAE data, (2) reporting acute phase study results only and (3) more restrictive reporting criteria. Trial summaries with zero SAE were 2.35 (95% CI, 1.58 to 3.49; p<0.001) times more likely to be published with no discrepancy in their associated journal article. Since clinicalstudyresults.org was removed from the Internet in 2011, only 7.8% of retrieved trial summaries appear with results on clinicaltrials.gov.Substantial discrepancies exist in SAE data found in journal articles and registered summaries of antidepressant and antipsychotic drug trials. Two main scientific sources accessible to clinicians and researchers are limited by incomplete, ambiguous and inconsistent reporting. Access to complete and accurate data from clinical trials of drugs currently in use remains a pressing concern.

SUBMITTER: Hughes S

PROVIDER: S-EPMC4091397 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Differences in reporting serious adverse events in industry sponsored clinical trial registries and journal articles on antidepressant and antipsychotic drugs: a cross-sectional study.

Hughes Shannon S Cohen David D Jaggi Rachel R

BMJ open 20140709 7

<h4>Objective</h4>To examine the degree of concordance in reporting serious adverse events (SAEs) from antidepressant and antipsychotic drug trials among journal articles and clinical trial summaries, and to categorise types of discrepancies.<h4>Design</h4>Cross-sectional study of summaries of all antidepressant and antipsychotic trials included in an online trial registry and their first associated stand-alone journal articles.<h4>Setting</h4>Clinicalstudyresults.org, sponsored by Pharmaceutica ...[more]

PMID: 25009136

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Project description:BackgroundMapping the international landscape of clinical trials may inform global health research governance, but no large-scale data are available. Industry or non-industry sponsorship may have a major influence in this mapping. We aimed to map the global landscape of industry- and non-industry-sponsored clinical trials and its evolution over time.MethodsWe analyzed clinical trials initiated between 2006 and 2013 and registered in the WHO International Clinical Trials Registry Platform (ICTRP). We mapped single-country and international trials by World Bank's income groups and by sponsorship (industry- vs. non- industry), including its evolution over time from 2006 to 2012. We identified clusters of countries that collaborated significantly more than expected in industry- and non-industry-sponsored international trials.Results119,679 clinical trials conducted in 177 countries were analysed. The median number of trials per million inhabitants in high-income countries was 100 times that in low-income countries (116.0 vs. 1.1). Industry sponsors were involved in three times more trials per million inhabitants than non-industry sponsors in high-income countries (75.0 vs. 24.5) and in ten times fewer trials in low- income countries (0.08 vs. 1.08). Among industry- and non-industry-sponsored trials, 30.3% and 3.2% were international, respectively. In the industry-sponsored network of collaboration, Eastern European and South American countries collaborated more than expected; in the non-industry-sponsored network, collaboration among Scandinavian countries was overrepresented. Industry-sponsored international trials became more inter-continental with time between 2006 and 2012 (from 54.8% to 67.3%) as compared with non-industry-sponsored trials (from 42.4% to 37.2%).ConclusionsBased on trials registered in the WHO ICTRP we documented a substantial gap between the globalization of industry- and non-industry-sponsored clinical research. Only 3% of academic trials but 30% of industry trials are international. The latter appeared to be conducted in preferentially selected countries.

Project description:Background:The Protecting Canadians from Unsafe Drugs Act will eventually require institutions to report all serious adverse drug reactions (ADRs), although the proposed regulations do not yet define what will need to be reported and by whom. Knowledge about the occurrence of serious ADRs in the hospital setting is needed to optimize the effectiveness of reporting and to determine the potential implications of mandatory reporting. Objectives:To quantify and characterize suspected serious ADRs in patients admitted to a general medicine service, to assess the likelihood of causality, and to determine inter-rater agreement for identification of ADRs and assessment of their likelihood. Methods:This prospective observational study involved 60 consecutive patients admitted to a general medicine service at a tertiary care teaching centre starting on March 28, 2016. The primary outcome was the number of serious ADRs, defined by Health Canada as ADRs that result in hospital admission, congenital malformation, persistent or significant disability or incapacity, or death; that are life-threatening; or that require significant intervention to prevent one of these outcomes. Medical records were reviewed independently by pairs of pharmacists for serious ADRs, and the likelihood of causality was assessed using the World Health Organization-Uppsala Monitoring Centre system. Inter-rater agreement was calculated using the kappa score, and disagreements were resolved by discussion and consensus. Results:Twenty-three serious ADRs occurred in the sample of 60 patients. The proportion of patients experiencing a serious ADR that contributed to the original hospital admission was 19/60 (32%, 95% confidence interval [CI] 20%-43%), and 4 patients (7%, 95% CI 0%-13%) experienced a serious ADR during their hospital stay. Inter-rater agreement for occurrence of serious ADRs was moderate (kappa 0.58, 95% CI 0.35-0.76). Conclusion:Reportable serious ADRs were common among patients admitted to a general medicine service. Canadian hospitals would face difficulties reporting all serious ADRs because of the frequency of their occurrence and the subjectivity of their identification.

Project description:ImportanceWomen are less likely to be promoted and hold leadership positions in academic medicine. How often academic articles are cited is a key measure of scholarly impact and frequently assessed for professional advancement; however, it is unknown whether peer-reviewed articles written by men and women are cited differently.ObjectiveTo evaluate whether academic articles from high-impact medical journals written by men and women are cited differently.Design, setting, and participantsIn this cross-sectional study of all original research and commentary articles from 5 high-impact medical journals (Annals of Internal Medicine, British Medical Journal, JAMA, JAMA Internal Medicine, and The New England Journal of Medicine) from 2015 to 2018, the gender of the primary and senior authors of each article were identified using an online database, and the number of times each article has been cited was identified using Web of Science. The number of citations by primary and senior author gender were then compared. Data were analyzed from July 2020 to April 2021.ExposuresPrimary and senior authors' genders.Main outcomes and measuresNumber of citations per article.ResultsAmong 5554 articles, women wrote 1975 (35.6%) as primary author and 1273 of 4940 (25.8%) as senior author. Original research articles written by women as primary authors had fewer median (interquartile range) citations than articles written by men as primary authors (36 [17-82] citations vs 54 [22-141] citations; P < .001) and senior authors (37 [17-93] citations vs 51 [20-128] citations; P < .001). Articles written by women as both primary and senior authors had approximately half as many median (interquartile range) citations as those authored by men as both primary and senior authors (33 [15-68] citations vs 59 [23-149] citations; P < .001). Differences in citations remained in each year of the study and were less pronounced among commentary articles.Conclusions and relevanceIn this study, articles written by women in high-impact medical journals had fewer citations than those written by men, particularly when women wrote together as primary and senior authors. These differences may have important consequences for the professional success of women and achieving gender equity in academic medicine.

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Differences in reporting serious adverse events in industry sponsored clinical trial registries and journal articles on antidepressant and antipsychotic drugs: a cross-sectional study.

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Differences in reporting serious adverse events in industry sponsored clinical trial registries and journal articles on antidepressant and antipsychotic drugs: a cross-sectional study.

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