This forum will focus on statistical opportunities and challenges associated with innovative approaches to design, monitoring, analysis and reporting of clinical trials and assessments of safety and effectiveness in the postmarket setting.
Horsham, PA, USA (PRWEB) March 29, 2012
This conference is for statisticians, clinicians, epidemiologists, those in drug safety, regulatory and medical communication. It will offer in-depth discussions on hot topics relevant to the evaluation of therapeutic products and includes input from key thought leaders from regulatory agencies, industry, and academia. Now in its sixth year, this interactive conference will offer a scientific poster session, a round table lunch, and opportunities for networking with colleagues.
Session topics will include:
- FDA Guidances: Multiple Endpoints in Clinical Trials and Non-Inferiority Clinical Trials
- Safety assessments during the pre- and post-marketing phases
- Novel approaches to establishing trust in data monitoring committees
- Clinical trial outcome assessments and good measurement science
- Subgroup analysis in clinical trials
“This forum will focus on statistical opportunities and challenges associated with innovative approaches to design, monitoring, analysis and reporting of clinical trials and assessments of safety and effectiveness in the postmarket setting,” says Program Chair Stephen Wilson, DrPH, Director, Division of Biometrics III, CDER, of the FDA. “We are looking forward to seeing everyone in April in Bethesda.”
This program has been developed by the FDA and the DIA Statistics Special Interest Area Community (SIAC).
DIA is a neutral, global, professional, member-driven association of nearly 18,000 professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices and related medical products. Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies and services to improve health and well being worldwide. Headquarters are in Horsham, Pa, USA, with offices in Basel, Switzerland; Tokyo, Japan; Mumbai, India; and Beijing, China. http://www.diahome.org.
Contacts: Joe Krasowski, DIA
Christine Tarlecki, DIA