scholarly journals Portuguese Authorship in Published Clinical Trials: Differences in Industry and Investigator Initiated Trials

2021 ◽  
Vol 34 (13) ◽  
Author(s):  
Maria Pinheiro Andrade ◽  
Daniela Matias ◽  
Joana Batuca ◽  
Nélia Gouveia ◽  
Hélder Mota-Filipe ◽  
...  

Introduction: The aim of this study was to investigate the Portuguese authorship in publications resulting from trials initiated by the industry or investigators and run in Portugal.Material and Methods: Clinical trials with Portuguese institutions as sponsor or recruiting centers, and registered in four clinical trial registries, in the last 14 years, were assessed. Publications of completed trials, from both the initiative of the industry and investigatorswere screened and compared.Results: The percentage of published trials initiated by industry and investigators was similar (28.0%). However, the percentage of completed investigator-initiated trials (43.6%) was lower when compared to industry trials (69.7%). There was a higher percentage of Portuguese authorship in published investigator-initiated trials when compared with industry-initiated trials (47.1% vs 8.5%, respectively). Moreover, industry-initiated trials with Portuguese authors were published in journals with lower journal impact factor when compared with those published without authorship of Portuguese investigators. Oncology was the therapeutic area with the highest number of clinical trial registrations and publications. However, in publications with Portuguese authors, industry Initiated trials mainly focused on neurology while investigator-initiated trials had a higher number of papers in the fields of gastroenterology and infection diseases. Published trials with Portuguese authorship, initiated by the industry or investigators, also targeted different populations and had different purposes. In both cases, no significant differences were observed in terms of the journal impact factor or in the alignment of the published randomized trials with the respective reporting guidelines.Discussion: When compared with previous publications, this study showed an increasing trend in the number of clinical trials in Portugal, published within similar timeframes, after trial conclusion. Even though both industry and investigator trials are published within the standards for reporting trials, the low number of Portuguese authorships in industry publications might underline the need for invigorating these independent clinical trials in Portugal by capacitating and empowering national clinical research teams.Conclusion: This study confirmed that even though all registered trials had the involvement of Portuguese institutions as a recruiting center, not all the published trials had Portuguese investigators as authors, mainly those initiated by the industry.

2019 ◽  
Vol 26 (7) ◽  
pp. 427-438
Author(s):  
Ángel Valderrama ◽  
Evaristo Jiménez-Contreras ◽  
Pilar Valderrama ◽  
Manuel Escabias ◽  
Pilar Baca

2018 ◽  
Vol 26 (3) ◽  
pp. 154-157
Author(s):  
VINÍCIUS YNOE DE MORAES ◽  
PRISCILA FRANTZ RUFF ◽  
CARLOS HENRIQUE FERNANDES ◽  
JOÃO BAPTISTA GOMES DOS SANTOS ◽  
JOÃO CARLOS BELLOTI ◽  
...  

ABSTRACT Objective To assess the applicability of randomized clinical trials and whether certain factors (surgeon experience/journal impact factor) influence their applicability. Methods In this survey study we used the Pubmed/Medline database to select 32 consecutive randomized clinical trials published between 2013 and 2015, involving hand surgery (high/low impact). These studies were independently assessed by 20 hand surgeons (with more or less than 10 years of practice) who answered 4 questions regarding their applicability. Agreement was assessed using Cohen’s kappa and comparison of proportions via chi-square statistics. P-value <5% constituted statistical significance. Results A total of 640 evaluations were produced, generating 2560 responses. A weak correlation was observed between less and more experienced respondents (kappa <0.2; range 0.119–0.179). Applicability between the least and most experienced respondents was similar (p = 0.424 and p = 0.70). Stratification by journal impact factor showed no greater propensity of applicability (p = 0.29) for any of the groups. Conclusions Low agreement was found between the respondents for the applicability of the randomized studies. Surgeon experience and journal impact do not seem to influence this decision. Level of Evidence II, Prospective comparative study.


2021 ◽  
pp. 1-22
Author(s):  
Metin Orbay ◽  
Orhan Karamustafaoğlu ◽  
Ruben Miranda

This study analyzes the journal impact factor and related bibliometric indicators in Education and Educational Research (E&ER) category, highlighting the main differences among journal quartiles, using Web of Science (Social Sciences Citation Index, SSCI) as the data source. High impact journals (Q1) publish only slightly more papers than expected, which is different to other areas. The papers published in Q1 journal have greater average citations and lower uncitedness rates compared to other quartiles, although the differences among quartiles are lower than in other areas. The impact factor is only weakly negative correlated (r=-0.184) with the journal self-citation but strongly correlated with the citedness of the median journal paper (r= 0.864). Although this strong correlation exists, the impact factor is still far to be the perfect indicator for expected citations of a paper due to the high skewness of the citations distribution. This skewness was moderately correlated with the citations received by the most cited paper of the journal (r= 0.649) and the number of papers published by the journal (r= 0.484), but no important differences by journal quartiles were observed. In the period 2013–2018, the average journal impact factor in the E&ER has increased largely from 0.908 to 1.638, which is justified by the field growth but also by the increase in international collaboration and the share of papers published in open access. Despite their inherent limitations, the use of impact factors and related indicators is a starting point for introducing the use of bibliometric tools for objective and consistent assessment of researcher.


2020 ◽  
Vol 13 (3) ◽  
pp. 328-333
Author(s):  
Sven Kepes ◽  
George C. Banks ◽  
Sheila K. Keener

BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Asger S. Paludan-Müller ◽  
Perrine Créquit ◽  
Isabelle Boutron

Abstract Background An accurate and comprehensive assessment of harms is a fundamental part of an accurate weighing of benefits and harms of an intervention when making treatment decisions; however, harms are known to be underreported in journal publications. Therefore, we sought to compare the completeness of reporting of harm data, discrepancies in harm data reported, and the delay to access results of oncological clinical trials between three sources: clinical study reports (CSRs), clinical trial registries and journal publications. Methods We used the EMA clinical data website to identify all trials submitted to the EMA between 2015 and 2018. We retrieved all CSRs and included all phase II, II/III or III randomised controlled trials (RCTs) assessing targeted therapy and immunotherapy for cancer. We then identified related records in clinical trial registries and journals. We extracted harms data for eight pre-specified variables and determined the completeness of reporting of harm data in each of the three sources. Results We identified 42 RCTs evaluating 13 different drugs. Results were available on the EMA website in CSRs for 37 (88%) RCTs, ClinicalTrials.gov for 36 (86%), the European Clinical Trials Register (EUCTR) for 20 (48%) and in journal publications for 32 (76%). Harms reporting was more complete in CSRs than other sources. We identified marked discrepancies in harms data between sources, e.g. the number of patients discontinuing due to adverse events differed in CSRs and clinical trial registers for 88% of trials with data in both sources. For CSRs and publications, the corresponding number was 90%. The median (interquartile range) delay between the primary trial completion date and access to results was 4.34 (3.09–7.22) years for CSRs, 2.94 (1.16–4.52) years for ClinicalTrials.gov, 5.39 (4.18–7.33) years for EUCTR and 2.15 (0.64–5.04) years for publications. Conclusions Harms of recently approved oncological drugs were reported more frequently and in more detail in CSRs than in trial registries and journal publications. Systematic reviews seeking to address harms of oncological treatments should ideally use CSRs as the primary source of data; however, due to problems with access, this is currently not feasible.


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