Clinical Trials Toolkit

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COMET: Core outcome measures in effectiveness trials

Published by ECRINCOMET

Clinical Trials Toolkit

The COMET Initiative brings together people interested in the development and application of agreed standardised sets of outcomes, known as ‘core outcome sets’ (COS). These sets represent the minimum that should be measured and reported in all clinical trials of a specific condition, but COS are also suitable for use in routine care, clinical audit and research other than randomised trials

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Cochrane Central Register of controlled trials

Published by ECRINCochrane Library

Clinical Trials Toolkit

The Cochrane Central Register of Controlled Trials (CENTRAL) is a highly concentrated source of reports of randomized and quasi-randomized controlled trials. In addition to bibliographic details (author, source, year, etc.) CENTRAL records will often include an abstract (a summary of the article). They do not contain the full text of the article.

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SPIRIT Statement (Standard Protocol items)

Published by SPIRITECRIN

Clinical Trials Toolkit

Reporting guideline defining standard protocol items for clinical trials. The evidence-based SPIRIT recommendations were developed using systematic, transparent methodology and broad consultation with 115 experts representing diverse stakeholders involved in the design, funding, conduct, review, and publication of trial protocols.

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Patient reported outcome measures in rare diseases: a narrative review (Slade et al, 2018)

Published by ECRINArticle authors

Clinical Trials Toolkit

This review explores some of the current issues around the utilisation of PROMs in rare diseases, including small patient populations and dearth of valid PROMs. Difficulties in validating new or current PROMs for use in clinical trials and research are discussed

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PARADIGM patient engagement toolbox

Published by ECRINPARADIGM

Clinical Trials Toolkit

This project deliverable centralises all PARADIGM’s co-created recommendations, tools and relevant background information to make patient engagement in medicines development easier for all. The toolbox could help develop clinical trials with a further enhanced patient-focus and improve the experience of patients participating in the trials. Developed by PARADIGM project.

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