Publications by authors named "V Halbe"
Introduction: An increased number of screen failure patients in a clinical trial increases time and cost required for the recruitment. Assessment of reasons for screen failure can help reduce screen failure rates and improve recruitment.
Materials And Methods: We collected retrospective data of human epidermal growth factor receptor (HER2) positive Indian breast cancer patients, who failed screening for phase 3 clinical trials and ascertained their reasons for screen failure from screening logs.
Article Synopsis
- Osteoporosis affects up to 50% of Indian postmenopausal women, and this study evaluated the efficacy and safety of the medication denosumab in this demographic.
- In a double-blind, multicenter phase 3 trial with 250 women aged 55 to 75, participants received either denosumab or placebo, with a focus on changes in bone mineral density (BMD) after six months.
- Results showed a 3.1% increase in BMD for those taking denosumab compared to placebo, with no serious side effects reported, confirming its effectiveness and tolerance in increasing BMD and reducing bone turnover.
US food and drug administration Indian site inspections: An experience.
Perspect Clin Res
April 2012
Since 2005, USFDA has begun inspections of Indian clinical trial investigator sites. This paper reports experience of an FDA inspection performed at two Indian centers. The inspection started with an in-depth discussion with the investigator and his team about the conduct of the clinical trial at the site and was followed by a tour of the important locations - registration, outpatient department, specialty clinic, medical record section, and special procedure department.
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