Data Sharing Statements for Clinical Trials: A Requirement of the International Committee of Medical Journal Editors.

08:00 EDT 5th June 2017 | BioPortfolio

Summary of "Data Sharing Statements for Clinical Trials: A Requirement of the International Committee of Medical Journal Editors."

The International Committee of Medical Journal Editors announces requirements that a data sharing plan be prospectively registered, and a data sharing statement be included in submitted manuscripts, for clinical trials to be published in ICMJE journals.


Journal Details

This article was published in the following journal.

Name: PLoS medicine
ISSN: 1549-1676
Pages: e1002315


DeepDyve research library

PubMed Articles [38892 Associated PubMed Articles listed on BioPortfolio]

Meta-analysis of randomized clinical trials in the era of individual patient data sharing.

Individual patient data (IPD) meta-analysis is considered to be a gold standard when the results of several randomized trials are combined. Recent initiatives on sharing IPD from clinical trials offer...

Data Sharing Statements for Clinical Trials: A Requirement of the International Committee of Medical Journal Editors.

El Comité Internacional de Editores de Revista Médicas (ICMJE) ha tomado la posición que el compartir los datos generados por los ensayos clínicos es una obligación ética, por cuanto los partici...

Improving data sharing in research with context-free encoded missing data.

Lack of attention to missing data in research may result in biased results, loss of power and reduced generalizability. Registering reasons for missing values at the time of data collection, or-in the...

Harmonising clinical trials within the Gynecologic Cancer InterGroup: consensus and unmet needs from the Fifth Ovarian Cancer Consensus Conference.

The Gynecologic Cancer InterGroup (GCIG) Fifth Ovarian Cancer Consensus Conference (OCCC) was held in Tokyo, Japan from 7 to 9 November 2015. It provided international consensus on 15 important questi...

Robust Chemistry: The Importance of Data and Methods Sharing.

"… Robustness in chemistry can be enhanced by increasing the adoption of best data-sharing practices and the use of photos and videos for sharing methods and practical knowledge. Journals are an int...

Clinical Trials [4995 Associated Clinical Trials listed on BioPortfolio]

Healing Statements and Their Effect on Post Operative Pain

This is a randomized clinical trial comparing the severity of post-operative pain and use of pain medication in women who are and are not exposed to healing statements before undergoing va...

Ethical Challenges of Consent in Data Sharing

In recent years, Mahidol Oxford Tropical Medicine Research Unit (MORU) has coordinated some of the largest international studies involving many sites in low-income and hard-to-reach settin...

The Effect of Different Financial Competing Interest Statements on Readers' Perceptions of Clinical Educational Articles

Financial ties with industry are common among doctors, academics and institutions. This trial aims to investigate the influence of different types of industry-linked activities on readers'...

Patient Perceptions and Willingness to Enroll in Clinical Trials

The objective of our study is to determine which factors affect willingness to participate in gynecologic oncology clinical trials. Women with a diagnosis of gynecologic malignancy will be...

Changes in Physical, Cognitive and Emotional Function 5 and 10 Years After Aneurysmal Subarachnoid Hemorrhage (aSAH)

The current study is a continuation of the study "Effect of early rehabilitation in patients with acute aSAH" which was approved by the Regional Committee for Medical Research Ethics, Sout...

Medical and Biotech [MESH] Definitions

Committees established to review interim data and efficacy outcomes in clinical trials. The findings of these committees are used in deciding whether a trial should be continued as designed, changed, or terminated. Government regulations regarding federally-funded research involving human subjects (the "Common Rule") require (45 CFR 46.111) that research ethics committees reviewing large-scale clinical trials monitor the data collected using a mechanism such as a data monitoring committee. FDA regulations (21 CFR 50.24) require that such committees be established to monitor studies conducted in emergency settings.

System established by the World Health Organization and the International Committee on Thrombosis and Hemostasis for monitoring and reporting blood coagulation tests. Under this system, results are standardized using the International Sensitivity Index for the particular test reagent/instrument combination used.

Works about randomized clinical trials that compare interventions in clinical settings and which look at a range of effectiveness outcomes and impacts.

Works about a study where participants are assigned to a treatment, procedure, or intervention by methods that are not random. Non-randomized clinical trials are sometimes referred to as quasi-experimental clinical trials or non-equivalent control group designs.

Work that is the report of a pre-planned clinical study of the safety, efficacy, or optimum dosage schedule of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques in humans selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. While most clinical trials concern humans, this publication type may be used for clinical veterinary articles meeting the requisites for humans. Specific headings for specific types and phases of clinical trials are also available.

Quick Search


DeepDyve research library

Relevant Topic

Clinical Approvals
Clinical trials are a set of procedures in medical research conducted to allow safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and efficacy data to be collected for health interventions (e.g...

Searches Linking to this Article