A recycling framework for the construction of Bonferroni‐based multiple tests

Burman, Carl‐Fredrik; Sonesson, Christian; Guilbaud, Olivier

doi:10.1002/sim.3513

Cited by 117 publications

(136 citation statements)

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“…164 OS and ORR were tested using a multiple testing procedure with an alpha-exhaustive 199 recycling strategy to control type-I error at the overall alpha level. 18 A subgroup analysis was performed on PFS data (ITT) for the following baseline 211 covariates: ER+ and PgR+ (yes/no); metastatic disease (yes/no); concomitant use of 212 bisphosphonates (yes/no); measurable disease (yes/no); prior chemotherapy for locally 213 advanced or metastatic breast cancer (yes/no); geographic region; prior systemic 214 estrogen containing HRT (yes/no); and visceral disease (yes/no). HRs and 95% CI 215…”

Section: Outcomes 159mentioning

confidence: 99%

“…OS and ORR were tested using a multiple testing procedure with an alpha-exhaustive 199 recycling strategy to control type-I error at the overall alpha level. 18 were calculated using the method of Ellis et al 19 EDoR and EDoCB allow a statistical 207 comparison to be made on the duration of response and clinical benefit between the 208 two treatment arms. An analysis of time to deterioration of TOI and FACT-B total 209 score was performed as described for PFS.…”

Section: Outcomes 159mentioning

confidence: 99%

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Fulvestrant 500 mg versus anastrozole 1 mg for hormone receptor-positive advanced breast cancer (FALCON): an international, randomised, double-blind, phase 3 trial

et al. 2016

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A note on versions:The version presented here may differ from the published version or from the version of record. If you wish to cite this item you are advised to consult the publisher's version. Please see the repository url above for details on accessing the published version and note that access may require a subscription.For more information, please contact eprints@nottingham.ac.uk The objective of the current study was to confirm the superior PFS advantage for 103 fulvestrant versus anastrozole observed in the FIRST study, in a double-blind Phase 3 104 design. The population for FALCON were postmenopausal women with hormone 105 receptor-positive locally advanced or metastatic breast cancer who had not received 106 prior endocrine therapy, in order to avoid reducing efficacy of the control arm through 107 exposure to adjuvant endocrine therapy. 108 METHODS 109 Study design 110The Fulvestrant and AnastrozoLe COmpared in hormonal therapy Naïve advanced 111 breast cancer (FALCON) trial (Clinicaltrials.gov: NCT01602380) is a Phase 3 112 randomised, double-blind, double-dummy, international, multicentre study that 113 compared the efficacy and tolerability of fulvestrant with anastrozole in 114 postmenopausal women with histologically confirmed ER+ and/or PgR+ locally 115 advanced or metastatic breast cancer. 116 Ethical approval 117The study was conducted in accordance with the Declaration of Helsinki and 118International Conference on Harmonisation/Good Clinical Practice guidelines. An 119 Randomisation and masking 133Patients were randomised sequentially (1:1) to fulvestrant 500 mg or anastrozole 1 mg 134 using a computer-generated randomisation scheme and an integrated voice/web 135 response system. Patients were stratified at randomisation according to locally 136 advanced or metastatic breast cancer; prior or no prior treatment with chemotherapy 137 for locally advanced or metastatic breast cancer; and measurable or non-measurable 138 disease. 139Study drugs were labelled using a unique identifier linked to the randomisation 140 scheme. The active study drug and placebo for fulvestrant (pre-filled syringes) and 141 anastrozole (tablets) were identically packaged to maintain blinding. 142 progression. Safety and tolerability were assessed at each study visit, and for up to 8 154 weeks after the last fulvestrant/placebo injection. HRQoL questionnaires were 155 administered at baseline and at 3-monthly intervals. Following disease progression or 156 treatment discontinuation, HRQoL questionnaires will be administered at 6-monthly 157 until a final OS analysis. 158 Outcomes 159The primary endpoint of the study was to demonstrate the superior PFS of patients 160 treated with fulvestrant vs anastrozole. A progression event was determined based on 161 tumour assessments performed locally by each investigator, and was defined by 162Response Evaluation Criteria in Solid Tumours (RECIST) 1·1, or 163 surgery/radiotherapy for worsening of disease, or death from any cause. 164 OS and ORR were tested using a multiple ...

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Section: Outcomes 159mentioning

confidence: 99%

Section: Outcomes 159mentioning

confidence: 99%

Fulvestrant 500 mg versus anastrozole 1 mg for hormone receptor-positive advanced breast cancer (FALCON): an international, randomised, double-blind, phase 3 trial

et al. 2016

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“…A similar comment applies for H 0 and H 0 . Hence, a source of possible improvement arises by looking for recent inferential methods that, taking advantage of the hierarchical structure of the hypotheses, allows for a better distribution of α on the various nodes of the tree (see, among others, Bretz et al 2009;Burman et al 2009;Goeman and Finos 2010). Many of these inferential methods can be seen as special cases of the sequential rejection principle of Goeman and Solari (2010), spurring us towards further developments in this direction.…”

Section: Concluding Remarks and Discussionmentioning

confidence: 99%

Assessing the pattern of covariance matrices via an augmentation multiple testing procedure

2011

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This paper extends the scedasticity comparison among several groups of observations, usually complying with the homoscedastic and the heteroscedastic cases, in order to deal with data sets laying in an intermediate situation. As is well known, homoscedasticity corresponds to equality in orientation, shape and size of the group scatters. Here our attention is focused on two weaker requirements: scatters with the same orientation, but with different shape and size, or scatters with the same shape and size but different orientation. We introduce a multiple testing procedure that takes into account each of the above conditions. This approach discloses a richer information on the data underlying structure than the classical method only based on homo/heteroscedasticity. At the same time, it allows a more parsimonious parametrization, whenever the patterned model is appropriate to describe the real data. The new inferential methodology is then applied to some well-known data sets, chosen in the multivariate literature, to show the real gain in using this more informative approach. Finally, a wide simulation study illustrates and compares the performance of the proposal using data sets with gradual departure from homoscedasticity.

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“…We propose to use a multiple testing procedure to conduct two sensitivity analyses, one for H Γ and one for H * Υ , correcting for multiple testing using the recycling method of Burman, Sonesson and Guilbaud (2009). The recycling procedure strongly controls the familywise error rate.…”

Section: An Algorithm For Matching To Ensure Separation On a Prodmentioning

confidence: 99%

Constructed Second Control Groups and Attenuation of Unmeasured Biases

Pimentel

Small

Rosenbaum

2016

Journal of the American Statistical Association

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The informal folklore of observational studies claims that if an irrelevant observed covariate is left uncontrolled, say unmatched, then it will influence treatment assignment in haphazard ways, thereby diminishing the biases from unmeasured covariates. We prove a result along these lines: it is true, in a certain sense, to a limited degree, under certain conditions. Alas, the conditions are neither inconsequential nor easy to check in empirical work; indeed, they are often dubious, more often implausible. We suggest the result is most useful in the computerized construction of a second control group, where the investigator can see more in available data without necessarily believing the required conditions. One of the two control groups controls for the possibly irrelevant observed covariate, the other control group either leaves it uncontrolled or forces separation; therefore, the investigator views one situation from two angles under different assumptions. A pair of sensitivity analyses for the two control groups is coordinated by a weighted Holm or recycling procedure built around the possibility of slight attenuation of bias in one control group. Issues are illustrated using an observational study of the possible effects of cigarette smoking as a cause of increased homocysteine levels, a risk factor for cardiovascular disease.

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A recycling framework for the construction of Bonferroni‐based multiple tests

Cited by 117 publications

References 11 publications

Fulvestrant 500 mg versus anastrozole 1 mg for hormone receptor-positive advanced breast cancer (FALCON): an international, randomised, double-blind, phase 3 trial

Fulvestrant 500 mg versus anastrozole 1 mg for hormone receptor-positive advanced breast cancer (FALCON): an international, randomised, double-blind, phase 3 trial

Assessing the pattern of covariance matrices via an augmentation multiple testing procedure

Constructed Second Control Groups and Attenuation of Unmeasured Biases

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