Using clinical trial data to restore the trial literature: what and how to ‘RIAT’?

Workshop category: 

  • Investigating bias
Date and Location

Date: 

Sunday 16 September 2018 - 11:00 to 12:30

Location: 

Tinto
Contact persons and facilitators

Contact person:

Larissa Shamseer
Peter Doshi

Facilitators:

Doshi P1, Jefferson T2, Jones M3, Shamseer L4
1 University of Maryland and The BMJ, USA
2 ARI Group/Nordic Cochrane Centre/Centre for Evidence Based Medicine, Italy
3 Acute Respiratory Infections Group, Australia
4 University of Ottawa, Canada
Target audience

Target audience: 

systematic reviewers, decision-makers, consumers

Level of difficulty: 

Advanced
Type of workshop

Type of workshop : 

Training
Abstract

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launched in 2018 to provide free-of-charge support to researchers wanting to correct the evidence base by publishing unpublished trials or by republishing misreported trials. We will also be running funding competitions where applicants can request up to USD 150,000 to restore (or 'RIAT') an unpublished or misreported trial.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

Relevance to patients and consumers: 

The bias present in the clinical trial literature has compromised healthcare decision-making. When information about harms and benefits are systematically excluded, or modified before they reach the public record, this disservice is potentially harmful to patients. Additionally, patients may be taking treatments that are not as beneficial as their marketing suggests, wasting limited healthcare resources that could be better spent elsewhere.