The triangular test to assess the efficacy of metoclopramide in gastroesophageal reflux*

Duhamel, J.F.; Guillot, M; Pariente-Khayat, Ann; Olivé, G; Pons, Gérard

doi:10.1016/s0009-9236(97)90170-3

Cited by 47 publications

(43 citation statements)

References 12 publications

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“…These include the dissemination of printed educational materials, use of local opinion leaders, use of reminders, provision of feedback and, adapting protocols according to perceived needs [39]. Finally, triangular test design, allowances for early study termination and other strategies to minimize sample size may decrease competition for patients [40,41].…”

Section: Discussionmentioning

confidence: 99%

Competing for patients: an ethical framework for recruiting patients with brain tumors into clinical trials

2011

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With more rapid advances in potential treatments for brain tumours, the number of clinical trials for brain tumour patients is rising. In the context of the challenges of recruitment and enrollment of patients with brain tumors, the dichotomy between the paucity of subjects and abundance of clinical trials creates a unique ethical dilemma, whereby a single patient may be eligible for several studies. Here, we identify and present three approaches for recruiting and enrolling patients who may be eligible for several trials. The ethical implications of the full disclosure, paternalistic, and random approaches are discussed. The full disclosure approach presents information to patients regarding all ongoing concurrent trials, allowing them to make an informed decision, while the paternalistic approach allows the healthcare providers to select the trial for which they believe the patient is most suitable. These introduce the biases into circumstances where equipoise is necessary and risk selection bias in study design. The random approach randomly allocates patients to each trial, which may erode patient autonomy and decrease trial enrollment. Brain tumor patients comprise a vulnerable population and it remains incumbent on healthcare providers to maintain the highest ethical standards when approaching them for clinical research. Changes in clinical trial design are required to mitigate the conflicts created by competition for patients. Keywords Brain tumors Á Clinical trials Á Ethics Á Patient enrollment Á Patient recruitment Illustrative caseA previously healthy 50 year old female, recently diagnosed with non-small cell lung carcinoma presents to a multi-disciplinary neuro-oncology clinic for evaluation of a single 1.5 cm metastasis in the right temporal lobe, discovered on screening magnetic resonance imaging (MRI). Standard treatment options would include surgical resection with adjuvant whole brain radiation therapy (WBRT), WBRT with radiosurgery boost or WBRT alone. She is also eligilible for two clinical trials offered at the hospital at which she is receiving treatment. One investigates the efficacy of a small molecular tyrosine kinase inhibitor in combination with radiosurgery and one investigates the inclusion of WBRT with radiosurgery treatment. The multi-disciplinary team meets to inform the patient of the institutional standard-of-care treatments and the two clinical trials available. They are faced with the challenge of effectively, fairly and ethically presenting the treatment options available.

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Section: Discussionmentioning

confidence: 99%

Competing for patients: an ethical framework for recruiting patients with brain tumors into clinical trials

2011

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“…Proof. First, lim a→∞ |E ξ {R (2) 2,a (h)}| = 0 follows by the same argument used to prove Theorem 7 of Weng and Woodroofe [17]. Next, since where E ξ [R 2,a (h a )1 {Na>ηa} ] → 0 as a → ∞ by Lemma 13.…”

Section: A2 Biases and Variances Of Estimatorsmentioning

confidence: 81%

“…To show that the effect of non-symmetry of h vanishes, observe that So, by definition ofτ (2) N and (35), N | is bounded, and √ a(ω N − 1) converges to a limit with mean zero and is uniformly integrable by Lemma 10. So E ξ (III N ) = o(1/ √ a).…”

Section: A2 Biases and Variances Of Estimatorsmentioning

confidence: 99%

Corrected confidence intervals for secondary parameters following sequential tests

Weng¹,

Coad²

2006

Institute of Mathematical Statistics Lecture Notes - Monograph Series

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Corrected confidence intervals are developed for the mean of the second component of a bivariate normal process when the first component is being monitored sequentially. This is accomplished by constructing a first approximation to a pivotal quantity, and then using very weak expansions to determine the correction terms. The asymptotic sampling distribution of the renormalised pivotal quantity is established in both the case where the covariance matrix is known and when it is unknown. The resulting approximations have a simple form and the results of a simulation study of two well-known sequential tests show that they are very accurate. The practical usefulness of the approach is illustrated by a real example of bivariate data. Detailed proofs of the main results are provided.

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“…Peace [111] presents an entire volume of preclinical and clinical real-world applications of sequential procedures to drug research and development. Furthermore, individual manuscripts [116], amongst many others.…”

Section: Software and Applicationmentioning

confidence: 99%

A 25‐year review of sequential methodology in clinical studies

Todd

2006

Statistics in Medicine

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SUMMARYThis paper explores the theoretical developments and subsequent uptake of sequential methodology in clinical studies in the 25 years since Statistics in Medicine was launched. The review examines the contributions which have been made to all four phases into which clinical trials are traditionally classified and highlights major statistical advancements, together with assessing application of the techniques. The vast majority of work has been in the setting of phase III clinical trials and so emphasis will be placed here. Finally, comments are given indicating how the subject area may develop in the future.

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The triangular test to assess the efficacy of metoclopramide in gastroesophageal reflux*

Cited by 47 publications

References 12 publications

Competing for patients: an ethical framework for recruiting patients with brain tumors into clinical trials

Competing for patients: an ethical framework for recruiting patients with brain tumors into clinical trials

Corrected confidence intervals for secondary parameters following sequential tests

A 25‐year review of sequential methodology in clinical studies

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