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What Is a Pragmatic Clinical Trial? [PDF]
Journal of Investigative Dermatology, 2015 Pragmatic trials Pragmatic clinical trials seek to determine the effectiveness of an intervention in a real-world setting to inform clinical decision making (Roland and Torgerson, 1998). Researchers designing pragmatic trials take particular care to ensure that the study population is as similar as possible to the population on which the intervention ...
Williams, Hywel C. +2 more
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Gatekeepers for pragmatic clinical trials [PDF]
Clinical Trials, 2015 To successfully implement a pragmatic clinical trial, investigators need access to numerous resources, including financial support, institutional infrastructure (e.g. clinics, facilities, staff), eligible patients, and patient data. Gatekeepers are people or entities who have the ability to allow or deny access to the resources required to support the ...
Danielle M, Whicher +3 more
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Trials, 2023 Background Arts therapies are widely but inconsistently provided in community mental health. Whilst they are appealing to patients, evidence for their effectiveness is mixed. Trials to date have been limited to one art-form or diagnosis.
Catherine E. Carr +5 more
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Increasing patient participation in oncology clinical trials
Cancer Medicine, 2023 Aim Timely recruitment of eligible participants is essential for the success of clinical trials, with insufficient accrual being the leading cause for premature termination of both oncology and non‐oncology trials.
Jie Chen, Ying Lu, Shivaani Kummar
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A comparison of approaches for adjudicating outcomes in clinical trials
Trials, 2017 Background Incorrect classification of outcomes in clinical trials can lead to biased estimates of treatment effect and reduced power. Ensuring appropriate adjudication methods to minimize outcome misclassification is therefore essential. While there are
Brennan C. Kahan +2 more
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Sequence balance minimisation: minimising with unequal treatment allocations
Trials, 2017 Background Minimisation ensures excellent balance between groups for several prognostic factors, even in small samples. However, its use with unequal allocation ratios has been problematic.
Vichithranie W. Madurasinghe
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Trials, 2018 Background Pre-specification of outcomes is an important tool to guard against outcome switching in clinical trials. However, if the outcome is not sufficiently clearly defined, then different definitions could be applied and analysed, with only the most
Brennan C. Kahan, Vipul Jairath
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A comparison of methods to adjust for continuous covariates in the analysis of randomised trials
BMC Medical Research Methodology, 2016 Background Although covariate adjustment in the analysis of randomised trials can be beneficial, adjustment for continuous covariates is complicated by the fact that the association between covariate and outcome must be specified.
Brennan C. Kahan +3 more
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Stakeholder perspectives regarding pragmatic clinical trial collateral findings
Learning Health Systems, 2021 Context Pragmatic clinical trials (PCTs), which are becoming widespread since they are relatively inexpensive and offer important benefits for healthcare decision‐making, can also present practical, ethical, and legal challenges.
Stephanie R. Morain +6 more
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Privacy and confidentiality in pragmatic clinical trials [PDF]
Clinical Trials, 2015 With pragmatic clinical trials, an opportunity exists to answer important questions about the relative risks, burdens, and benefits of therapeutic interventions. However, concerns about protecting the privacy of this information are significant and must be balanced with the imperative to learn from the data gathered in routine clinical practice ...
Deven, McGraw +5 more
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