Volume 14 Supplement 1

2nd Clinical Trials Methodology Conference: Methodology Matters

Open Access

Update on the temper study: targeted monitoring, prospective evaluation and refinement

  • Sally Stenning1,
  • Nicola Joffe1,
  • Priyanka Batra1,
  • Catrin Jones1,
  • Carlos Diaz Montana1,
  • Nancy Tappenden1 and
  • Sarah Meredith1
Trials201314(Suppl 1):P138

https://doi.org/10.1186/1745-6215-14-S1-P138

Published: 29 November 2013

Background

On-site monitoring is a high-cost process, particularly if used indiscriminately in a large multicentre clinical trial. Ideally, the focus should be on identification and resolution of serious problems in trial conduct affecting patient safety and/or data quality. Targeted monitoring, where trial data and conduct are scrutinised centrally, with pre-specified triggers for site visits, may be an efficient way to prioritise on-site monitoring. Though widely used, this approach has not been formally evaluated.

Methods

With funding from CRUK, and using a prospective matched-pair design, we are evaluating targeted monitoring within several multicentre cancer trials being conducted by the MRC Clinical Trials Unit. Using the pre-specified triggers for each trial, sites prioritised for a site visit will be matched (on number of patients recruited and time since trial site opened) with one that would not be visited based on the normal monitoring strategy. Paired sites will be visited and a standard monitoring report completed. The primary analysis will compare the proportion of sites with at least one critical or major monitoring finding in triggered vs. matched sites. 84 visits (42 pairs) will be carried out; the study is powered to detect a 30% difference in the proportion of sites with critical/ major findings (80% power, 5% 2 sided-significance level). An important secondary analysis will evaluate individual triggers as prognostic factors for findings.

Status

The study is on-going; progress including development of reports to help monitor triggers, and the practical challenges in embedding evaluative methodological studies in open trials will be presented.

Authors’ Affiliations

(1)
MRC Clinical Trials Unit Hub for Trials Methodology Research

Copyright

© Stenning et al; licensee BioMed Central Ltd. 2013

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Advertisement