Showing papers by "Sally P. Stenning published in 2012"
TL;DR: It is suggested that with better central and targeted on- site monitoring, it should be possible to identify and address most protocol and procedural compliance issues without performing intensive and costly routine on-site data monitoring.
Abstract: Background Compliance with Good Clinical Practice (GCP) guidelines should ensure the safety of trial participants and the reliability of trial results. Over the last decade, increasing emphasis has been placed on the role of costly on-site monitoring and source data verification as processes to demonstrate that GCP is being followed, despite a lack of empirical evidence that these are effective.Purpose To assess whether findings from on-site monitoring of a recent international multi-centre clinical trial could have been identified using central data review and other centralised monitoring techniques.Methods Findings documented in a sample of site monitoring reports, and Programme Management Board Executive (PMBe) reports, from the Microbicides Development Programme (MDP) 301 trial – a randomised placebo-controlled trial of a microbicide gel to prevent vaginally acquired HIV infection conducted in four countries in East and Southern Africa – were extracted and individually assessed to determine whether th...
71 citations
TL;DR: There is a lack of published empirical data that compare monitoring strategies prospectively, and assessment of the usefulness and cost-effectiveness of monitoring techniques in a variety of clinical trial settings and indications is needed.
Abstract: BackgroundAs part of a broader methodological programme of work around clinical trial monitoring, we wanted to evaluate the existing evidence for the effectiveness of different monitoring techniques.PurposeTo identify and evaluate prospective studies of the effectiveness of different monitoring strategies.MethodsA systematic search of MEDLINE from 1950 onwards, using free-text terms to identify relevant published studies. We intended to extract data on details of comparative techniques, monitoring findings identified by different techniques, and recommendations or identification of areas in need of further research made by authors.ResultsA total of 1222 published abstracts were identified and reviewed. Of these, nine articles described methods for quality control (QC) of clinical trial activities, and one article was identified that compared the same monitoring technique at two timepoints. None included a direct comparison of different monitoring techniques and findings.LimitationsThe search strategy was ...
18 citations
TL;DR: The aim of ST03 is to assess the safety and feasibility (stage I, first 200 pts) and efficacy (stage II) of the addition of B to perioperative ECX chemotherapy.
Abstract: TPS4143 Background: Perioperative ECX chemotherapy is a standard of care for localised gastric/OGJ/lower oesophageal adenocarcinoma (Cunningham NEJM 2006). B is a monoclonal antibody targeting VEGF...
15 citations
TL;DR: It is suggested that the socio-economic gradient in testicular cancer survival in the general population is more likely to be attributable to health care system factors than to personal or socio- economic factors in the men themselves.
10 citations