Our Clinical Trials – Case Studies
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Idiopathic Pulmonary Fibrosis
A Respiratory Case Study
Worldwide Clinical Trials has conducted three studies in Idiopathic Pulmonary Fibrosis (IPF), including Phase II, phase III, and open label extension studies. Services provided for these studies included clinical monitoring, depot services, drug safety, investigators meetings, logistics, project management, quality assurance, regulatory services, and translations. As a result, Worldwide is familiar with the peculiarities of IPF, including the importance of FVC as a reliable, valid, and responsive measure of disease status in patients with IPF; UIP as the characteristic histological pattern of IPF; definite UIP diagnosis through HRCT; and the meaning of % diffusing capacity (of the lung) for carbon monoxide. Additionally, Worldwide’s experts understand the pharmacologic treatment options and the use of pirfenidone as SoC in some countries but not in others; the need to identify “Centers of Excellence” in each country, because of limited number of centers with the expertise, experience and contacts with networks like the Pulmonary Fibrosis Foundation in the US and Eur IPF Net; and modalities of performing the six-minute walking test in IPF. As an example, Worldwide conducted a double blind, randomized, placebo-controlled, dose-ranging, Phase II trial evaluating the safety and efficacy of an investigational product in patients with IPF. Worldwide was responsible for conducting the study in Russia, and screened 21 patients and randomized 10 patients from three sites over 13 months with an enrollment rate of 3.1 patient/site/year. 80% of the randomized patients completed the 52-week study. A critical point in this study execution was the close collaboration of expert pulmonologists, radiologists, and pathologists at the investigational centers, which was facilitated by Worldwide’s expert study management team.
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