Eligibility Criteria of Randomized Controlled Trials—Reply

Fowler, Robert; Spall, Harriette G.C. Van

doi:10.1001/jama.298.1.39-b

Cited by 4 publications

(4 citation statements)

References 6 publications

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“…Exclusion criteria should correlate with the clinical trial's primary and secondary outcomes and must be well-justified. A systematic review of almost three hundred trials published in high-impact journals between 1994 and 2006 found a majority (84.1%) of trials contained at least one poorly justified exclusion criterion with a quarter of all exclusion criteria being poorly justified in 61.5% of randomized controlled trials (Fowler and Van Spall, 2007). Investigators defined poorly justified criteria as those based on age, race, educational background, socioeconomic status, or other factors with no direct bearing on the condition or intervention.…”

Section: Phase III Trial Patients and Real-world Patient Gapmentioning

confidence: 99%

Precision Dosing Priority Criteria: Drug, Disease, and Patient Population Variables

et al. 2020

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The administered dose of a drug modulates whether patients will experience optimal effectiveness, toxicity including death, or no effect at all. Dosing is particularly important for diseases and/or drugs where the drug can decrease severe morbidity or prolong life. Likewise, dosing is important where the drug can cause death or severe morbidity. Since we believe there are many examples where more precise dosing could benefit patients, it is worthwhile to consider how to prioritize drug-disease targets. One key consideration is the quality of information available from which more precise dosing recommendations can be constructed. When a new more precise dosing scheme is created and differs significantly from the approved label, it is important to consider the level of proof necessary to either change the label and/or change clinical practice. The cost and effort needed to provide this proof should also be considered in prioritizing drug-disease precision dosing targets. Although precision dosing is being promoted and has great promise, it is underutilized in many drugs and disease states. Therefore, we believe it is important to consider how more precise dosing is going to be delivered to high priority patients in a timely manner. If better dosing schemes do not change clinical practice resulting in better patient outcomes, then what is the use? This review paper discusses variables to consider when prioritizing precision dosing candidates while highlighting key examples of precision dosing that have been successfully used to improve patient care.

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Section: Phase III Trial Patients and Real-world Patient Gapmentioning

confidence: 99%

Precision Dosing Priority Criteria: Drug, Disease, and Patient Population Variables

et al. 2020

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“… 3 Relaxing eligibility criteria is a straightforward strategy to facilitate more inclusive trials and to improve recruitment. 4 , 5 However, in some instances, this can negatively impact the clinical relevance of the study. Other aspects related to the study design can also play an important role for the completion of clinical trials.…”

Section: Introductionmentioning

confidence: 99%

Accrual and statistical power failure in published adjuvant phase III oncology trials: a comprehensive analysis from 2013 to 2023

Villacampa,

Dennett,

Mello

et al. 2024

ESMO Open

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“…Furthermore, both patients and surgeons can have a strong preference for a certain treatment, which forms an obstacle for randomization in surgical trials [10]. The patient populations encountered in daily clinical practice often differ from the highly selected patient populations enrolled in randomized controlled trials [11].…”

Section: Introductionmentioning

confidence: 99%

Let’s Agree to Disagree on Operative versus Nonoperative (LADON) treatment for proximal humerus fractures: Study protocol for an international multicenter prospective cohort study

et al. 2022

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Background The proximal humerus fracture is a common injury, but the optimal management is much debated. The decision for operative or nonoperative treatment is strongly influenced by patient specific factors, regional and cultural differences and the preference of the patient and treating surgeon. The aim of this study is to compare operative and nonoperative treatment of proximal humerus fractures for those patients for whom there is disagreement about optimal management. Methods and analysis This protocol describes an international multicenter prospective cohort study, in which all patients of 18 years and older presenting within three weeks after injury with a radiographically diagnosed displaced proximal humerus fracture can be included. Based on patient characteristics and radiographic images several clinical experts advise on the preferred treatment option. In case of disagreement among the experts, the patient can be included in the study. The actual treatment that will be delivered is at the discretion of the treating physician. The primary outcome is the QuickDash score at 12 months. Propensity score matching will be used to control for potential confounding of the relation between treatment modality and QuickDash scores. Discussion The LADON study is an international multicenter prospective cohort study with a relatively new methodological study design. This study is a “natural experiment” meaning patients receive standard local treatment and surgeons perform standard local procedures, therefore high participation rates of patients and surgeons are expected. Patients are only included after expert panel evaluation, when there is proven disagreement between experts, which makes this a unique study design. Through this inclusion process, we create two comparable groups whom received different treatments and where expert disagree about the already initiated treatment. Since we are zooming in on this particular patient group, confounding will be largely mitigated. Internationally the treatment of proximal humerus fractures are still much debated and differs much per country and hospital. This observational study with a natural experiment design will create insight into which treatment modality is to be preferred for patients in whom there is disagreement about the optimal treatment strategy. Trial registration Registered in Netherlands trial register NL9357 and Swiss trial register CH 2020–00961; https://clinicaltrials.gov/.

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Eligibility Criteria of Randomized Controlled Trials—Reply

Cited by 4 publications

References 6 publications

Precision Dosing Priority Criteria: Drug, Disease, and Patient Population Variables

Precision Dosing Priority Criteria: Drug, Disease, and Patient Population Variables

Accrual and statistical power failure in published adjuvant phase III oncology trials: a comprehensive analysis from 2013 to 2023

Let’s Agree to Disagree on Operative versus Nonoperative (LADON) treatment for proximal humerus fractures: Study protocol for an international multicenter prospective cohort study

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