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Over 200 publications, including the composite endpoints regulators now recognize. We publish our methodology in the open so reviewers meet it before your submission does.

200+
Publications
1996–2026
Span
28
Contributing authors
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Global Statistical Tests: powering the trial your budget can actually fund

When the sample size a conventional design demands is larger than the trial you can run, a Global Statistical Test lets the clinical-endpoint hypotheses be tested anyway. The paper sets out when GST applies, how it is pre-specified, and how it has been received in review.

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Research

Publications library

3 publications

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  1. 2005 · Alzheimer's & Dementia

    [02-01-05]: A placebo-controlled, double-blind trial of the selective AB-42 lowering agent, flurizan (MPC-7869,(R)-flurbiprofen) in patients with mild to moderate Alzheimer's disease

    Hendrix, Suzanne

    Abstract

    Background: Several epidemiological studies have suggested that longer-term use of NSAIDs may reduce the risk of developing Alzheimer's disease (AD). Although there were encouraging results from some earlier studies, more recent longer-term, larger, placebo-controlled clinical trials utilising drugs with an anti-inflammatory action have produced disappointing outcomes. Re-analysis of the epidemiological data has shown that the protective effect is limited to a subgroup of NSAIDs, including flurbiprofen, which have Aβ-42 lowering properties and which were not used in the previous longer-term placebo-controlled trials. Flurizan (MPC-7869 (R)-flurbiprofen) is a single enantiomer of flurbiprofen, which has been shown to lower brain levels of Aβ-42 in a mouse model of AD (Tg2576), with some evidence of an effect on learning and memory. There is little risk of gastric toxicity because of a lack of anti-COX activity, and the compound has been shown to be safe and well tolerated in healthy older volunteers (55-80yrs) at doses of up to 1600mg per day when administered for 21 days in a phase I study. It is therefore an exciting potential disease modifying treatment for AD. Objective(s): This presentation will provide efficacy and safety data from a clinical trial of Flurizan, which to our knowledge will be the first multi-centre, placebo-controlled, double-blind clinical study of a selective Aβ-42 lowering agent in patients with mild to moderate Alzheimer's disease. Methods: This is a one-year trial evaluating both 400mg BID and 800mg BID of (R)-flurbiprofen per day, in 210 patients (50% female) with mild to moderate AD (MMSE 15-26). It employed the ADAS-cog, ADCS-ADL, CDR-sb, CIBIC plus, NPI and MMSE as outcome measures. At baseline the mean age of the subjects was 75 years with an average MMSE score 21 and an average standard ADAS-cog score 23. Of the patients enrolled in the trial, 94 per cent were also taking stable doses of cholinesterase inhibitors. Concomitant treatment with memantine was not allowed. Conclusions: The study completes in March 2005, and the cognitive, functional, global and behavioural outcomes will be presented, together with the safety data.

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  2. 2005 · Cereal Chemistry

    Sensory, mechanical, and microscopic evaluation of staling in low-protein and gluten-free breads

    Hendrix, Suzanne

    Abstract

    Abstract: Staling over a 120-hr period was compared in a gluten-free rice bread, a low-protein starch bread, and two gluten-containing breads (standard wheat and added-protein wheat) using quantitative descriptive analysis (QDA), critical stress values obtained by mechanical compression testing, and scanning electron microscopy (SEM). The gluten-free rice bread had the highest QDA scores for both moistness and overall freshness, whereas the low-protein starch bread had the lowest scores for both attributes. Differences in critical stress values over the 120-hr period demonstrated that the gluten-free rice bread had the greatest resistance to mechanical collapse, indicating the least structural damage, whereas the low-protein starch bread had the least resistance to mechanical collapse. Both wheat breads had QDA moistness and freshness scores, and critical stress values that ranged between the gluten-free rice and low-protein starch breads. SEM showed the formulation containing rice, egg and milk proteins, xanthan gum, and hydroxypropylmethylcellulose created a bicontinuous matrix with starch fragments, similar to gluten.

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  3. 2005 · Encyclopedia of statistics in behavioral science

    Partial correlation coefficients

    Brown, Bruce · Hendrix, Suzanne

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