Article type
Year
Abstract
Background:
Randomized controlled trials are known as medicine’s 'gold standard' for reliable evidence, but they are undermined by two fundamental problems: 1) not all trials conducted are published, and 2) many trials that are published are misreported. The RIAT (Restoring Invisible and Abandoned Trials) initiative was established to address these problems. The RIAT Support Center was launched in 2018 to provide free-of-charge support to researchers wanting to correct the evidence base by publishing unpublished trials or by republishing misreported trials. We will also be running funding competitions where applicants can request up to USD 150,000 to restore (or 'RIAT') an unpublished or misreported trial. RIAT will facilitate a more accurate understanding of the safety and efficacy of medical interventions. While methods to consider the inclusion of alternate sources of trial data to journal publications are evolving within Cochrane, restoring the published trial literature is important because most systematic reviews remain based on journal article evidence, and are thus dependent on reliable, accurate, and complete reporting.
Objectives:
To introduce systematic reviewers, decision-makers, consumers, and other interested parties to the RIAT concept, the methodology of trial restoration, how to access data, and how to extract data from different types of trial documents.
Description:
We will give a short presentation to start the workshop, providing an overview of the scope and purpose of the RIAT initiative, the RIAT-recommended steps to restoring a trial, and the different types of trial regulatory documents and data. The workshop activity* will consist of:
- hands-on exposure for how to access clinical study reports (CSRs) and other regulatory documents, including how to submit a freedom of information request;
- guided walk through the different components of a CSR, using an actual example of a previously confidential CSR;
- an activity comparing data available in a trial publication with CSR of the same trial, and discussion on data extraction.
*Participants are requested to bring a laptop
Randomized controlled trials are known as medicine’s 'gold standard' for reliable evidence, but they are undermined by two fundamental problems: 1) not all trials conducted are published, and 2) many trials that are published are misreported. The RIAT (Restoring Invisible and Abandoned Trials) initiative was established to address these problems. The RIAT Support Center was launched in 2018 to provide free-of-charge support to researchers wanting to correct the evidence base by publishing unpublished trials or by republishing misreported trials. We will also be running funding competitions where applicants can request up to USD 150,000 to restore (or 'RIAT') an unpublished or misreported trial. RIAT will facilitate a more accurate understanding of the safety and efficacy of medical interventions. While methods to consider the inclusion of alternate sources of trial data to journal publications are evolving within Cochrane, restoring the published trial literature is important because most systematic reviews remain based on journal article evidence, and are thus dependent on reliable, accurate, and complete reporting.
Objectives:
To introduce systematic reviewers, decision-makers, consumers, and other interested parties to the RIAT concept, the methodology of trial restoration, how to access data, and how to extract data from different types of trial documents.
Description:
We will give a short presentation to start the workshop, providing an overview of the scope and purpose of the RIAT initiative, the RIAT-recommended steps to restoring a trial, and the different types of trial regulatory documents and data. The workshop activity* will consist of:
- hands-on exposure for how to access clinical study reports (CSRs) and other regulatory documents, including how to submit a freedom of information request;
- guided walk through the different components of a CSR, using an actual example of a previously confidential CSR;
- an activity comparing data available in a trial publication with CSR of the same trial, and discussion on data extraction.
*Participants are requested to bring a laptop