The EU Clinical Trials Regulation: key priorities, purposes and aims and the implications for public health

Flear, Mark

doi:10.1136/medethics-2015-103258

Cited by 12 publications

(8 citation statements)

References 6 publications

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“…While improved experimental and/or reporting standards 101 may be providing a more accurate representation of effect sizes in more recent publications, there was no relationship between p values and publication year, nor was there a difference between studies published prior to (or in/after) 2016, which was the year when the Clinical Trial Regulation requirements were instituted with the aim of improving experimental and/or reporting standards for clinical trials. 98 Taken together, we found no clear reason for the significant effect of publication year on the observed improvement in depression scores from pre-diet to post-diet. In fact, we found that despite the improved experimental and/or reporting standards of recent years, 101 the observed reduction in depression scores between pre-diet to postdiet remains clear and significant.…”

Section: Discussioncontrasting

confidence: 54%

Effects of total diet replacement programs on mental well‐being: A systematic review with meta‐analyses

et al. 2022

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This systematic review with meta-analyses assessed the effects of total diet replacement (TDR) programs on mental well-being in clinical trial participants with a body mass index greater than or equal to 25 kg/m 2 . TDR programs involve replacing all dietary requirements with nutritionally replete formula foods and are generally administered to induce rapid weight loss. To date, it is largely unclear what effects TDR programs may have on mental well-being, particularly in the long-term. To address this, we screened 25,976 references across six databases and extracted 35 publications. These 35 publications provided sufficient data to evaluate the effects of TDR programs on depression, anxiety, stress, positive affect, negative affect, vitality, role-emotional, social functioning, mental health, mental composite summary score, self-esteem, and general psychological health in 24 meta-analyses.Due to the lack of research comparing TDR programs to comparator groups, 22 of our 24 meta-analyses explored change in these mental well-being sub-domains over time in TDR programs without comparators. Specifically, we assessed the change from pre-diet (before the TDR program) to either post-diet (up to and including two months after the TDR program); and/or follow-up (more than two months after the TDR program). For depression and anxiety, we were also able to assess the change from pre-diet to mid-diet (which fell within two weeks of the diet half-way point). The remaining two meta-analyses assessed the difference in depression scores between a TDR group and a food-based comparator group from pre-diet to post-diet and from pre-diet to follow-up. Across all meta-analyses, our results found no marked adverse effects of TDR programs on any mental well-being sub-domain. In fact, clear improvements were observed for depression, anxiety, stress, vitality, role-emotional, and social functioning at post-diet. Interestingly, the improvements for depression, vitality and role-emotional were maintained at follow-up. All improvements were

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Section: Discussioncontrasting

confidence: 54%

Effects of total diet replacement programs on mental well‐being: A systematic review with meta‐analyses

et al. 2022

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“…Furthermore, the EU CTR provides a detailed explanation of this registration and authorisation process and how it might result in a seemingly delayed registration date owing to its technical implementation—over which the investigators have no control—although registration should still be validated as a prospective registration in accordance with the ICMJE guidelines 80. The significantly higher compliance in prospective trial registration in the EU CTR registry compared with the rest of the WHO trial registries, might be attributed to the 2014 legal requirements for registration and publication of the results of clinical trials in the European Union, and to the rigor of the registration process in the EU CTR registry 81. In fact, the authors of a publication of a retrospectively registered trial included in our study reported that they were able to register successfully in ClinicalTrials.gov after their initial trial registration was declined at the EU CTR 70.…”

Section: Discussionmentioning

confidence: 99%

Prospective registration and reporting of trial number in randomised clinical trials: global cross sectional study of the adoption of ICMJE and Declaration of Helsinki recommendations

Al-Durra

Nolan

Seto

et al. 2020

BMJ

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Objectives To evaluate the compliance with prospective registration and inclusion of the trial registration number (TRN) in published randomised controlled trials (RCTs), and to analyse the rationale behind, and detect selective registration bias in, retrospective trial registration. Design Cross sectional analysis. Data sources PubMed, the 17 World Health Organization’s trial registries, University of Toronto library, International Committee of Medical Journal Editors (ICMJE) list of member journals, and the InCites Journal Citation Reports. Study selection criteria RCTs registered in any WHO trial registry and published in any PubMed indexed journal in 2018. Results This study included 10 500 manuscripts published in 2105 journals. Overall, 71.2% (7473/10500) reported the TRN and 41.7% (3013/7218) complied with prospective trial registration. The univariable and multivariable analyses reported significant relations (P<0.05) between reporting the TRN and the impact factor and ICMJE membership of the publishing journal. A significant relation (P<0.05) was also observed between prospective trial registration and the registry, region, condition, funding, trial size, interval between paper registration and submission dates, impact factor, and ICMJE membership of the publishing journal. A manuscript published in an ICMJE member journal was 5.8 times more likely to include the TRN (odds ratio 5.8, 95% confidence interval 4.0 to 8.2), and a published trial was 1.8 times more likely to be registered prospectively (1.8, 1.5 to 2.2) when published in an ICMJE member journal compared with other journals. This study detected a new form of bias, selective registration bias, with a higher proportion (85.2% (616/723)) of trials registered retrospectively within a year of submission for publication. Higher rates of retrospective registrations were observed within the first three to eight weeks after enrolment of study participants. Within the 286 RCTs registered retrospectively and published in an ICMJE member journal, only 2.8% (8/286) of the authors included a statement justifying the delayed registration. Reasons included lack of awareness, error of omission, and the registration process taking longer than anticipated. Conclusions This study found a high compliance in reporting of the TRN for trial papers published in ICMJE member journals, but prospective trial registration was low.

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“…Legislation in the field of clinical trials is represented by the international acts, besides, by EU acts, and also by the national legislation of each state. The stage of development of each particular state's legislation was actively studied, including compliance with EU acts respectively [3][4][5].…”

Section: Review and Discussionmentioning

confidence: 99%

Contractual Registration of Organizational and Legal Relations Between Subjects Involved in the Conduct of Clinical Trials of Medicinal Products

Antoniuk¹,

Pavliuchenko

Vyshnyvetskyy

2020

Wiad Lek

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The aim: Determination of features of contractual registration of organizational and legal relations between the subjects involved in carrying out clinical trials of medicinal products; justification of proposals on improvement of law enforcement practice in this field. Materials and methods: This research is based on the analysis of the norms of international law and legislation of particular states, practice of contractual registration of organizational and legal relations between the subjects of clinical trials of medicinal products. The research was carried out using the methods of dialectical and formal logic, general scientific and special legal research methods. Conclusions: Two models of contractual registration of organizational and legal relations between the subjects involved in clinical trials of medicinal products were justified, and law enforcement recommendations for the contractual registration of such relationships, ensuring that the clinical trial is in compliance with international regulations and ethics in this field, were given.

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The EU Clinical Trials Regulation: key priorities, purposes and aims and the implications for public health

Cited by 12 publications

References 6 publications

Effects of total diet replacement programs on mental well‐being: A systematic review with meta‐analyses

Effects of total diet replacement programs on mental well‐being: A systematic review with meta‐analyses

Prospective registration and reporting of trial number in randomised clinical trials: global cross sectional study of the adoption of ICMJE and Declaration of Helsinki recommendations

Contractual Registration of Organizational and Legal Relations Between Subjects Involved in the Conduct of Clinical Trials of Medicinal Products

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