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The TRIPS regime for test data protection and access to medicines
Published in Olasupo Owoeye, Intellectual Property and Access to Medicines in Africa, 2019
In 2004, the Global Forum and Ministerial Summit on Health Research issued the Statement on Health Research which emphasised the need to promote access to reliable ‘and up-to-date evidence on the effects of interventions’ and called on the WHO to create a platform connecting ‘a network of international clinical trials registers to ensure a single point of access and the unambiguous identification of trials’.106 This was further reinforced by the fifty-eighth World Health Assembly in Resolution WHA58.34. As a result, the International Clinical Trial Registry Platform (ICTRP) was established by the WHO in 2005, with the aim of enhancing the WHO Trial Registration Data Set on all Clinical Trials and promoting public accessibility to the information.107 The ICTRP search portal provides a one-stop point of access on information relating to current or completed clinical trials by using records submitted by data providers all over the world. The ICTRP is largely dependent on both national and regional regimes for implementation and enforcement.108 Whilst the creation of the ICTRP is undoubtedly a significant step towards ensuring the accessibility of clinical trials data, a number of experts have taken the view that the ICTRP minimal data set was somewhat inadequate and more information would be required for any meaningful analysis of clinical trials to be possible.109
Historical aspects of research misconduct: Europe
Published in Frank Wells, Michael Farthing, Fraud and Misconduct in Biomedical Research, 2019
Nevertheless, in the publishing world, two organizations stand out. They are the Committee on Publication Ethics (COPE), referred to in detail elsewhere in this book, and the International Committee of Medical Journal Editors (ICMJE), which has made real progress by insisting that, as a prerequisite for consideration for publication as from 1 July 2005, all clinical trials other than phase I studies must be registered in a public trials registry prior to when the first subject was enrolled.30 In early 2006, there were only two registries accepted by the ICMJE: www.ClinicalTrials.gov (www.clinicaltrials.gov) (a service of the US National Institutes of Health) and the International Standardised Randomised Clinical Trial Numbering scheme (www.isrctn.org). There has been a subsequent explosion of growth in the number of registries that have opened. One that is fundamental for Europe, because it registers and gives a unique number to all clinical trials throughout the continent, is the European Clinical Trials Database, EudraCT (www.eudract.emea.europa.eu). The World Health Organization (WHO) has also developed an International Clinical Trials Registry Platform, ICTRP (www.who.int/ictrp/en), through which all WHO registries will be accessible. It is planned that this will be an internationally accepted centralized repository for clinical trial information (registries and results) and be fully functional by 2008.31
Publication and Outcome Reporting Bias
Published in Christopher H. Schmid, Theo Stijnen, Ian R. White, Handbook of Meta-Analysis, 2020
Arielle Marks-Anglin, Rui Duan, Yong Chen, Orestis Panagiotou, Christopher H. Schmid
While the careful and thorough literature searches outlined in Section 1.3 of Chapter 1 are the most effective way to uncover reports of studies and their results, other resources are needed to find what is unreported. The recognition that many studies were never published prompted scientific agencies to call for and mandate the creation of registries listing studies that they sponsored and funded. Thus, the protocols of all clinical trials of humans funded and regulated by the United States government through the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) are required by law to be registered with the National Library of Medicine at Clinicaltrials.gov. ClinicalTrials.gov is now the largest database of ongoing and completed clinical trials in the world and includes nearly 300,000 research studies from 204 countries. Since 2009, many studies are also required to submit information about the progress of participants through the study, baseline characteristics, outcome measures, statistical analysis, and adverse events within one year of the study’s completion date (Clinicaltrials.gov, 2017). The European Medicines Agency (EMA) of the European Union (EU) has similar regulations and has a registry of its own called the EU Clinical Trials Register which started in 2004. The World Health Organization (WHO) has established the International Clinical Trials Registry Platform (ICTRP) to facilitate a network of registries across the world that meet specific criteria for content, quality and validity, accessibility, unique identification, technical capacity, and administration. Registration is also supported by the requirement of journals that are members of the International Committee of Medical Journal Editors (ICMJE) that studies be prospectively registered in order to be eligible for publication (De Angelis et al., 2004). Other study registries have been established by private companies (e.g., GlaxoSmithKline at www.gsk-clinicalstudyregister.com).
A narrative review of course evaluation methods for continuing professional development: The case of paediatric and neonatal acute-care in-service courses in low and lower-middle income countries: BEME Guide No. 76
Published in Medical Teacher, 2023
Alison Gifford, Rune Philemon, Jay Halbert, Eleanor J. Hothersall, Rebecca Inglis, Jo Hart, Lucie Byrne-Davis, Joanna Thirsk, Hugh Gifford, Rachel Howells, Shona Weetch, Katie Prentice, Andy Jackson, Martin Kirkpatrick
The following databases were included, searched in November 2018 then updated in December 2020: OVID Medline, OVID Embase, ERIC, CINAHL, Web of Science, Scopus, Cochrane, African Index Medicus, Index Medicus for the Eastern Mediterranean Region (IMEMR), IndMED (India), Latin America and the Caribbean (LILAC), Western Pacific Region Index Medicus (WPRIM). An example search strategy is shown in Supplementary Appendix 1. The following clinical trial registries: clinicaltrials.gov, WHO International Clinical Trials Registry Platform (ICTRP). Reference lists of influential studies were checked for additional papers. The following keywords were included: paediatric, neonatal, children, emergency, acute, resuscitation, low income, low resource, resource-poor, developing country, outcome, evaluation.
The complexities of AAC intervention research: emerging trends to consider
Published in Augmentative and Alternative Communication, 2018
MaryAnn Romski, Rose A. Sevcik
The World Health Organization (WHO) has developed an International Clinical Trials Registry Platform (ICTRP; http://www.who.int/ictrp/en/). The WHO website states that, ‘The registration of all interventional trials is a scientific, ethical and moral responsibility’. A clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Clinical trials also may be referred to as intervention trials. Interventions include, but are not restricted to, drugs, cells, and other biological products, surgical procedures, radiologic procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc. This definition includes Phase I to Phase IV trials, as described in Table 1.
Clinical trial transparency update: an assessment of the disclosure of results of company-sponsored trials associated with new medicines approved in Europe in 2014
Published in Current Medical Research and Opinion, 2018
Bryan R. Deane, Sheuli Porkess
The most comprehensive source of information was the US National Institutes of Health (NIH) national registry, ClinicalTrials.gov, which identified 2032 registered trials (irrespective of sponsor and trial status) related to the 32 medicines assessed. The European registry (EudraCT, clinicaltrialsregister.eu) included 654 associated trials, the majority of which were also registered on ClinicalTrials.gov. Some of the company registries provided additional information (15 of the medicines were associated with companies which had registries). The WHO International Clinical Trials Registry Platform (ICTRP), which provides access to 17 national and regional primary registries, was also searched.