Clinical trial teams are wasting time and money on overly cautious monitoring procedures that do little to protect patients. The problem is that many trial organisations have adopted monitoring and management procedures that are disproportionate to the actual risks, adding unnecessary workload, complexity, and cost—especially for lower-risk cancer trials. The researchers are testing whether a more targeted, evidence-based approach—called triggered monitoring—can effectively identify problem sites without burdening every trial with the same heavy oversight. Separately, they have found that offering monetary incentives is the only reliable way to boost participant retention in trials; non-monetary rewards and extra reminders have little effect. The work also tackles bias in systematic reviews: relying solely on published trial reports to assess risk of bias can be unreliable, and reviewers should seek additional information from investigators where possible. If adopted, these findings could streamline trial conduct, reduce costs, and improve the validity of meta-analyses that guide treatment decisions—without compromising patient safety.
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Our work in this area involves investigating and improving trial data checking and monitoring, as well as reducing bias and improving the validity of our systematic reviews. Some of the important outcomes are: Evidence-based trial monitoring • Many trials organisations have implemented trial management and monitoring procedures out of proportion to the risks to trial participants or the public, thereby increasing the workload, complexity and cost of lower-risk trials. We initiated the TEMPER study to evaluate prospectively whether triggered monitoring is effective at distinguishing problem sites in ongoing CTU multicentre cancer trials. Increasing participant retention in trials • Our systematic review of strategies to increase participant retention specifically in RCTs has shown that monetary incentives and offers of monetary incentives increase postal and electronic questionnaire response. Non-monetary incentives, additional communication and reminder strategies and most modified questionnaires have little impact. Informing systematic review conduct • CTU is leading a Network-funded project to develop a ‘state of the art’ series of papers on Individual participant data (IPD) meta-analyses and recently hosted a workshop of international experts to discuss topics. Most systematic reviews now assess risk of bias of eligible trials based on their publications (often using the Cochrane Collaboration tool), and it has been proposed that these are used as a basis for including or weighting trials in a meta-analysis. An evaluation of publication-based assessments showed that they can be unreliable, compared to those based on information obtained from investigators or protocols (as part of our IPD meta-analyses). In particular, reviewers should be cautious about using these as a basis for trial inclusion, and instead seek additional information from trialists, where possible.
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