Clinical trials : journal of the Society for Clinical Trials
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Review
A systematic review of on-site monitoring methods for health-care randomised controlled trials.
Monitoring the conduct of clinical trials is recommended by International Conference of Harmonisation Good Clinical Practice (ICH GCP) guidelines and is integral to trial quality assurance. On-site monitoring, that is, visiting trial sites, is one part of this process but little is known about the procedures that are performed in practice. ⋯ This review demonstrated that on-site monitoring is utilised in trials worldwide but systems vary considerably with little evidence to support practice. These on-site monitoring practices need to be evaluated empirically, including costs, to provide robust evidence for the contribution of site visits to trial performance and quality.
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Randomized Controlled Trial
Conducting the ACTIVE randomized trial in hospice care: keys to success.
Untreated pain is common for patients at the end of life. Informal caregivers, often family or friends of patients, are responsible for working with hospice staff to provide pain management. Interdisciplinary team meetings conducted in hospices every 2 weeks provide an opportunity for hospice staff to communicate about pain management with informal caregivers of hospice patients. ⋯ The challenges of conducting randomized trials with hospice patients and caregivers can be addressed with appropriate study design, well-tested research methods, and proactive monitoring of any issues or problems.
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Obtaining surrogate consent for clinical research studies conducted in the intensive care unit (ICU) setting is logistically challenging. ⋯ Surrogate and self-consent rates were similar. Surrogate unavailability was a major barrier to enrollment; overlap of staffing with usual visiting hours should be considered when planning trials in the ICU.
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Many randomized controlled trials (RCTs) collect cost-effectiveness data. Without appropriate sample size calculations, patient recruitment may cease before the cost-effectiveness of the intervention can be established or continue after the cost-effectiveness of the intervention is established beyond doubt. ⋯ Economic evaluations conducted alongside RCTs are valuable, but often present inconclusive evidence. Trial results may lead to discordant messages when the most effective intervention is probably not the most cost-effective. Despite methodological advances, trialists rarely assessed the extent to which their trial might resolve the key uncertainties about the cost-effectiveness of interventions. We recommend that grant funders should do more to encourage trialists to include economic end points in sample size calculations, particularly when the majority of costs and benefits of the intervention occur within the time frame of the trial.