Optimizing the Data Available Via Health Canada\u27s Clinical Information Portal

Through its Public Release of Clinical Information initiative, Health Canada has provided public access to a vast repository of data that have been submitted to support market authorization of drugs and medical devices. Health Canada has released data from more than 160 submissions for drugs, biologics, vaccines and medical devices. The regulator is currently in its third year of a 4-year phase-in schedule to release clinical data proactively from submissions for all new active substances, new clinical indications, generic drugs and higher-risk devices that are approved, withdrawn or rejected. Substantial clinical data submitted by the industry sponsor of the application, including summary-level data and metadata are made publicly available by Health Canada as a matter of policy

Retracted papers originating from paper mills: cross sectional study

OBJECTIVES To describe retracted papers originating from paper mills, including their characteristics, visibility, and impact over time, and the journals in which they were published. DESIGN Cross sectional study. SETTING The Retraction Watch database was used for identification of retracted papers from paper mills, Web of Science was used for the total number of published papers, and data from Journal Citation Reports were collected to show characteristics of journals. PARTICIPANTS All paper mill papers retracted from 1 January 2004 to 26 June 2022 were included in the study. Papers bearing an expression of concern were excluded. MAIN OUTCOME MEASURES Descriptive statistics were used to characterise the sample and analyse the trend of retracted paper mill papers over time, and to analyse their impact and visibility by reference to the number of citations received. RESULTS 1182 retracted paper mill papers were identified. The publication of the first paper mill paper was in 2004 and the first retraction was in 2016; by 2021, paper mill retractions accounted for 772 (21.8%) of the 3544 total retractions. Overall, retracted paper mill papers were mostly published in journals of the second highest Journal Citation Reports quartile for impact factor (n=529 (44.8%)) and listed four to six authors (n=602 (50.9%)). Of the 1182 papers, almost all listed authors of 1143 (96.8%) paper mill retractions came from Chinese institutions and 909 (76.9%) listed a hospital as a primary affiliation. 15 journals accounted for 812 (68.7%) of 1182 paper mill retractions, with one journal accounting for 166 (14.0%). Nearly all (n=1083, 93.8%) paper mill retractions had received at least one citation since publication, with a median of 11 (interquartile range 5-22) citations received. CONCLUSIONS Papers retracted originating from paper mills are increasing in frequency, posing a problem for the research community. Retracted paper mill papers most commonly originated from China and were published in a small number of journals. Nevertheless, detected paper mill papers might be substantially different from those that are not detected. New mechanisms are needed to identify and avoid this relatively new type of misconduct

Transparency of Regulatory Data across the European Medicines Agency, Health Canada, and US Food and Drug Administration

Based on an analysis of relevant laws and policies, regulator data portals, and information requests, we find that clinical data, including clinical study reports, submitted to the European Medicines Agency and Health Canada to support approval of medicines are routinely made publicly available

'Show me the evidence' : mobilisation, citizenship and risk in Indian asbestos issues

This paper examines asbestos issues, mobilisation and citizenship in India. It shows how asbestos has been considered as a tool for Indian economic growth and modernisation and explores the scientific debates around its ‘safe’ use. In seeking to locate experiences of citizenship within a globalised context, this research has focused on anti-asbestos mobilisation and protest in cosmopolitan cities as well as more decentralised contexts. It argues that the state’s narrow definition of asbestos diseases enables it to officially document the lack of asbestos diseases experienced by Indian workers. This process, which defines sufferers as politically invisible and inconsequential, accompanied by the 30 year delay between exposure and the onset of disease, hinders anti-asbestos organisations as there is no constituency to be mobilised. Parallel (and partially interrelated) grassroots asbestos movements which are more worker-orientated are, however, marginalised from the transnational protests. The paper argues that mobilisation around identity issues thus creates different contexts in India, in which activists are simultaneously both intimately connected and enormously distant to different aspects of the mobilisation process. In addition, while geographic and political differences are compressed through transnational mobilisation; class, regional and educational differences are expanded. Keywords: asbestos; mobilisation; citizenship; anti-asbestos mobilisation; India; asbestos diseases

Data sharing: not as simple as it seems

In recent years there has been a major change on the part of funders, particularly in North America, so that data sharing is now considered to be the norm rather than the exception. We believe that data sharing is a good idea. However, we also believe that it is inappropriate to prescribe exactly when or how researchers should preserve and share data, since these issues are highly specific to each study, the nature of the data collected, who is requesting it, and what they intend to do with it. The level of ethical concern will vary according to the nature of the information, and the way in which it is collected - analyses of anonymised hospital admission records may carry a quite different ethical burden than analyses of potentially identifiable health information collected directly from the study participants. It is striking that most discussions about data sharing focus almost exclusively on issues of ownership (by the researchers or the funders) and efficiency (on the part of the funders). There is usually little discussion of the ethical issues involved in data sharing, and its implications for the study participants. Obtaining prior informed consent from the participants does not solve this problem, unless the informed consent process makes it completely clear what is being proposed, in which case most study participants would not agree. Thus, the undoubted benefits of data sharing does not remove the obligations and responsibilities that the original investigators hold for the people they invited to participate in the study