Timothy R. Franson

Transforming Objective Participatory Patient Advocacy

Pat Furlong, Timothy R. Franson, Peter J. Pitts

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Meeting report: the ALPHA project: a stakeholder meeting on lupus clinical trial outcome measures and the patient perspective

Joy Buie, Lauren Bloch, Eric F. Morand, Ronald van Vollenhoven et autres

Drug development in lupus has improved over the past 10 years but still lags behind that of other rheumatic disease areas. Assessment of prospective lupus therapies in clinical trials has proved challenging for reasons that are multifactorial including the heterogeneity of the …

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The ALPHA Project: Establishing consensus and prioritisation of global community recommendations to address major challenges in lupus diagnosis, care, treatment and research

Karin Tse, Sanjyot Sangodkar, Lauren Bloch, Kathleen Arntsen et autres

The Addressing Lupus Pillars for Health Advancement (ALPHA) Project is a global consensus effort to identify, prioritise and address top barriers in lupus impacting diagnosis, care, treatment and research. To conduct this process, the ALPHA Project convened a multistakeholder Global Advisory Committee …

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Unique Burdens of Pediatric Clinical Trials in Duchenne Muscular Dystrophy, April 20–21, 2017, Bethesda, Maryland, USA

Timothy R. Franson, Kathi Kinnett, Timothy P. Cripe

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Constructing an innovative medical and pharmaceutical industry in China

Timothy R. Franson

This chapter presents a framework for guiding policy-making with respect to constructing an innovative medical and pharmaceutical industry in China. The concept of pharmaceutical innovation presupposes that some unmet health need exists in a given population, for which a new product would …

How a patient advocacy group developed the first proposed draft guidance document for industry for submission to the U.S. Food and Drug Administration

Pat Furlong, John F. P. Bridges, Lawrence Charnas, Justin R. Fallon et autres

Among the challenges confronting patients with rare diseases is a dearth of treatment options. The development of safe and effective new therapies is hampered by challenges associated with conducting clinical trials in small populations. In this article, we describe how the Duchenne …

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The Practicing Clinician and Regulatory Safety Concerns

Ryan McAllister, Timothy R. Franson, Carl Kraus

Pharmaceutical agents are prescribed to produce a therapeutic effect, but safety concerns require constant attention to the benefit:risk relationship inherent in their use and the needs of the individual patient. Such calculations involve assumptions about the likely tolerability of harm, in that …

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Effect of individualized pharmacokinetic dosing on patient outcome

Julianne K. Whipple, Robert K. Ausman, Timothy R. Franson, Edward J. Quebbeman

OBJECTIVE: To study the effect of individualized pharmacokinetic dosing of aminoglycosides on patient outcome. DESIGN: Prospective, randomized study. SETTING: Tertiary care hospital. PATIENTS: Ninety-five patients with documented Gram-negative infections received 97 courses of aminoglycoside therapy. INTERVENTIONS: Patients were randomized between pharmacokinetic dose …

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Panel I. Drug utilization review: Criteria*

D. Craig Brater, Beth Benedict, W. Gary Erwin, Timothy R. Franson et autres

Clinical Pharmacology and Therapeutics (1991) 50, 626–628; doi:10.1038/clpt.1991.196

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Adherence of Microorganisms to Breast Prostheses: An In Vitro Study

James R. Sanger, Neela K. Sheth, Timothy R. Franson

The quantitative and morphological characteristics of microbial adherence of four organisms--Staphylococcus epidermidis, S. aureus, Escherichia coli and Candida albicans--to the surfaces of different breast prostheses were observed. Semiquantitative adherence studies based on a modification of Maki's roll culture technique even after short …

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Serial Bilirubin Determinations as a Prognostic Marker in Clinical Infections

Timothy R. Franson, Douglas R. LaBrecque, Brian P. Buggy, Gary J. Harris et autres

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Adherence of Microorganisms to Breast Prostheses: An In-vitro Study

James R. Sanger, Neela K. Sheth, Timothy R. Franson