Incorporating the sample correlation into the testing of two endpoints in clinical trials.

We introduce an improved Bonferroni method for testing two primary endpoints in clinical trial settings using a new data-adaptive critical value that explicitly incorporates the sample correlation coefficient. Our methodology is developed for the usual Student's t-test statistics for testing the means under normal distributional setting with unknown population correlation and variances. Specifically, we construct a confidence interval for the unknown population correlation and show that the estimated type-1 error rate of the Bonferroni method with the population correlation being estimated by its lower confidence limit can be bounded from above less conservatively than using the traditional Bonferroni upper bound.

Exact critical values for group sequential designs with small sample sizes.

Group sequential clinical trial designs allow the sequential hypothesis testing as data is accumulated over time, while ensuring the control of type-1 error rate. These designs vary in how they split the overall type-1 error among analyses, but practically, all assume that: 1. The underlying data is normal or approximately so, and 2.

A Phase II, Randomized, Double-Blind Clinical Study Evaluating the Safety, Tolerability, and Efficacy of a Topical Minocycline Foam, FMX103, for the Treatment of Facial Papulopustular Rosacea.

Objective: Our objective was to demonstrate the safety, tolerability, and efficacy of a minocycline foam, FMX103, in the treatment of moderate-to-severe facial papulopustular rosacea.

Methods: This was a phase II, randomized, double-blind, multicenter study. Healthy subjects aged ≥ 18 years with moderate-to-severe rosacea that had been diagnosed ≥ 6 months previously and with ≥ 12 inflammatory facial lesions were randomized (1:1:1) to receive once-daily 1.

Non-inferiority versus superiority drug claims: the (not so) subtle distinction.

Background: Current regulatory guidance and practice of non-inferiority trials are asymmetric in favor of the test treatment (Test) over the reference treatment (Control). These trials are designed to compare the relative efficacy of Test to Control by reference to a clinically important margin, M.

Main Text: Non-inferiority trials allow for the conclusion of: (a) non-inferiority of Test to Control if Test is slightly worse than Control but by no more than M; and (b) superiority if Test is slightly better than Control even if it is by less than M.

Five-day study to judge the short-term effect of a benzoyl peroxide 3% gel on acne lesions.

Introduction: Acne is a common, chronic skin disease that has both physical and psychological consequences. Over-the-counter products are a treatment option frequently chosen by dermatologists and acne sufferers for reasons of cost or convenience. There are reports that such products can effect rapid resolution in certain lesion parameters.

An improved Hochberg procedure for multiple tests of significance.

We propose a simple modification of Hochberg's step-up Bonferroni procedure for multiple tests of significance. The proposed procedure is always more powerful than Hochberg's procedure for more than two tests, and is more powerful than Hommel's procedure for three and four tests. A numerical analysis of the new procedure indicates that its Type I error is controlled under independence of the test statistics, at a level equal to or just below the nominal Type I error.

Validation of a photonumeric wrinkle assessment scale for assessing nasolabial fold wrinkles.

Background: Reliable clinical assessment tools are needed to evaluate the effects of injectable devices and fillers. This study was designed to validate a new photonumeric wrinkle assessment scale using standardized photographic methodology to obtain reference photographs.

Methods: Multiple photographs (test set) from approximately 78 volunteer subjects with varying degrees of severity of the left/right nasolabial fold wrinkles were examined.

Beneficial effects of docosahexaenoic acid on cognition in age-related cognitive decline.

Background: Docosahexaenoic acid (DHA) plays an important role in neural function. Decreases in plasma DHA are associated with cognitive decline in healthy elderly adults and in patients with Alzheimer's disease. Higher DHA intake is inversely correlated with relative risk of Alzheimer's disease.

Bioequivalence of Docosahexaenoic acid from different algal oils in capsules and in a DHA-fortified food.

Docosahexaenoic acid (DHA), a long-chain omega-3 fatty acid, is important for eye and brain development and ongoing visual, cognitive, and cardiovascular health. Unlike fish-sourced oils, the bioavailability of DHA from vegetarian-sourced (algal) oils has not been formally assessed. We assessed bioequivalence of DHA oils in capsules from two different algal strains versus bioavailability from an algal-DHA-fortified food.

Culture and assessment of manic symptoms.

Cultural background may influence the perception of psychiatric symptoms. We examined the effects of cultural biases on the identification of manic symptoms using the Young Mania Rating Scale. Two video interviews, each with an American person with mania, were shown to psychiatrists from three countries (US, UK and India).