Biostatistics Research Today is a free monthly online journal that collates and summarizes the latest research about Biostatistics, including details on statistics, uncertainty, probability, modeling.

Experiences with learning and confirming in drug and biological development.

Patterson SD

Pfizer Vaccine Research, Philadelphia, Pennsylvania, USA. patters4@wyeth.com

Since the 1997 landmark article by Dr. Lewis Sheiner in Clinical Pharmacology & Therapeutics, biopharmaceutical development in phases I-IIA has become more targeted toward learning (i.e., establishing proof of concept), then subsequently confirming that regulated standards are met. The purpose and importance of the learning-proof-of-concept phase is subjective but typically uses traditional statistics (which were developed for use in confirming). Two examples from development are presented to illustrate learning in practice. Suggestions for how to improve and embed the learn-confirm concept and how to enhance the contributions of clinical pharmacology and statistics are considered.

Published 21 July 2010 in Clin Pharmacol Ther, 88(2): 161-3.
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Articles on Biostatistics published 21 July 2010:

ASCPT Task Force for advancing pharmacometrics and integration into drug development.   Clin Pharmacol Ther, 88(2): 158-61.

Traditionally, medical and biostatistical experts have played a central role in ensuring validity of pharmaceutical testing. The science of pharmacometrics provides powerful approaches for supporting important drug development and regulatory decisions. Numerous case studies published by academic, industry, and US Food and Drug Administration scientists attest to the significant contribution of pharmacometrics to decision making. The economic and public health benefits of applying this ... [Abstract] [Full-text]

Articles on Biostatistics published 16 June 2010:

A compendium of genome-wide associations for cancer: critical synopsis and reappraisal.   J Natl Cancer Inst, 102(12): 846-58.

Since 2007, genome-wide association (GWA) studies have identified numerous well-supported, novel genetic risk loci for common cancers; however, there are concerns that this technology is reaching its limits. We provide an overview of GWA-identified genetic associations with solid tumors. We simulated the distribution of population risk alleles for colorectal, prostate, testicular, and thyroid cancers based on genetic variants identified in GWA studies. We also evaluated whether statistical ... [Abstract] [Full-text]

Articles on Biostatistics published 3 November 2009:

Comparison and evaluation of ocular biometry using a new noncontact optical low-coherence reflectometer.   Ophthalmology, 116(11): 2087-92.

PURPOSE: To evaluate a new high-resolution noncontact biometer (Lenstar; Haag-Streit AG, Koeniz, Switzerland) using optical low-coherence reflectometry and to compare the clinical measurements with those obtained from the IOLMaster (Carl Zeiss, Jena, Germany) and the Pachmumeter (Haag-Streit AG). DESIGN: Exploratory evaluation of diagnostic technology and nonrandomized, prospective clinical trial. PARTICIPANTS: Eighty subjects (144 eyes) aged 20 to 90 years with cataractous, pseudophakic, ... [Abstract] [Full-text]

Articles on Biostatistics published 27 October 2009:

Role of lifestyle and aging on the longitudinal change in cardiorespiratory fitness.   Arch Intern Med, 169(19): 1781-7.

BACKGROUND: Cardiorespiratory fitness (CRF) in adults decreases with age and is influenced by lifestyle. Low CRF is associated with risk of diseases and the ability of older persons to function independently. We defined the longitudinal rate of CRF decline with aging and the association of aging and lifestyle with CRF. METHODS: We studied a cohort of 3429 women and 16 889 men, aged 20 to 96 years, from the Aerobics Center Longitudinal Study who completed 2 to 33 health examinations from 1974 to ... [Abstract] [Full-text]

Articles on Biostatistics published 26 October 2009:

Adequacy of vitamin D replacement in severe deficiency is dependent on body mass index.   Am J Med, 122(11): 1056-60.

BACKGROUND: Obesity is associated with hypovitaminosis D. Whether body mass index (BMI) determines the replacement dose of vitamin D to achieve sufficiency is unclear. OBJECTIVE: To determine the relationship between BMI and serum 25-OH vitamin D concentrations and whether the increase in serum 25-OH vitamin D concentrations with vitamin D replacement is dependent on BMI. METHODS: Retrospective review of anthropometric data and serum 25-OH vitamin D concentrations in 95 patients attending an ... [Abstract] [Full-text]

Articles on Biostatistics published 16 October 2009:

Convergence of body mass index of immigrants to the Canadian-born population: evidence from the National Population Health Survey (1994-2006).   Eur J Epidemiol, 24(10): 611-23.

Recent immigrants typically have better physical health than the native born population. However, this 'healthy immigrant effect' tends to gradually wane over time, with increasing length of residence in the host country. To assess whether the body mass index (BMI) of different immigrant groups converged to the Canadian population's levels, we estimated 12-year trajectories of changes in BMI (accounting for socio-demographic changes). Using data from seven longitudinal waves of the National ... [Abstract] [Full-text]

Articles on Biostatistics published 13 October 2009:

Progressive increase in body mass index is not associated with a progressive increase in joint space narrowing in obese women with osteoarthritis of the knee.   Ann Rheum Dis, 68(11): 1734-8.

OBJECTIVE: Given that obesity is a risk factor for osteoarthritis (OA) of the knee, a study was undertaken to determine whether progressively higher body mass index (BMI) among obese women is associated with progressive increases in joint space narrowing (JSN). METHODS: Medial compartment JSN over 12 months in Lyon Schuss radiographs of 60 obese women (BMI 30.0-50.5 kg/m(2)) with radiographic and symptomatic OA was compared with that in 81 non-obese women (BMI <28 kg/m(2)) with normal ... [Abstract] [Full-text]

Articles on Biostatistics published 12 October 2009:

Prepregnancy body mass index, gestational weight gain, and the likelihood of major depressive disorder during pregnancy.   J Clin Psychiatry, 70(9): 1290-6.

OBJECTIVE: We assessed the relation between prepregnancy body mass index (BMI) and the likelihood of major depressive disorder (MDD) during pregnancy and tested whether this association was modified by gestational weight gain. METHOD: Women (N = 242) were enrolled at < 20 weeks gestation into a prospective cohort study. Diagnosis of MDD was made with the Structured Clinical Interview for DSM-IV at 20, 30, and 36 weeks gestation. Gestational weight gain was compared with the 1990 Institute of ... [Abstract] [Full-text]

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