Central statistical monitoring of investigator-led clinical trials in oncology
Open Access
- 1 July 2020
- journal article
- review article
- Published by Springer Science and Business Media LLC in International Journal of Clinical Oncology
- Vol. 25 (7), 1207-1214
- https://doi.org/10.1007/s10147-020-01726-6
Abstract
Investigator-led clinical trials are pragmatic trials that aim to investigate the benefits and harms of treatments in routine clinical practice. These much-needed trials represent the majority of all trials currently conducted. They are however threatened by the rising costs of clinical research, which are in part due to extensive trial monitoring processes that focus on unimportant details. Risk-based quality management focuses, instead, on "things that really matter". We discuss the role of central statistical monitoring as part of risk-based quality management. We describe the principles of central statistical monitoring, provide examples of its use, and argue that it could help drive down the cost of randomized clinical trials, especially investigator-led trials, whilst improving their quality.This publication has 34 references indexed in Scilit:
- Linear mixed‐effects models for central statistical monitoring of multicenter clinical trialsStatistics in Medicine, 2014
- Sequential paclitaxel followed by tegafur and uracil (UFT) or S-1 versus UFT or S-1 monotherapy as adjuvant chemotherapy for T4a/b gastric cancer (SAMIT): a phase 3 factorial randomised controlled trialThe Lancet Oncology, 2014
- Randomized Clinical Trials — Removing Unnecessary ObstaclesThe New England Journal of Medicine, 2013
- The Value of Source Data Verification in a Cancer Clinical TrialPLOS ONE, 2012
- Improving the quality of drug research or simply increasing its cost? An evidence‐based study of the cost for data monitoring in clinical trialsBritish Journal of Clinical Pharmacology, 2011
- Validation of a risk-assessment scale and a risk-adapted monitoring plan for academic clinical research studies — The Pre-Optimon studyContemporary Clinical Trials, 2011
- Ensuring trial validity by data quality assurance and diversification of monitoring methodsClinical Trials, 2008
- Researchers Facing Increasing Costs for Clinical Research, With Few SolutionsJNCI Journal of the National Cancer Institute, 2005
- The control of the false discovery rate in multiple testing under dependencyThe Annals of Statistics, 2001
- Explanatory and pragmatic attitudes in therapeutical trialsJournal of Chronic Diseases, 1967