DIA invites patients and patient organizations to attend the Clinical Trial Endpoints Workshop to network with other stakeholders in the rare diseases community.
Horsham, PA (PRWEB) October 23, 2012
DIA is proud to announce a one-day workshop on clinical trial measurements with an emphasis on rare diseases. Clinical Trial Endpoints: Methods and Practice in Developing Measurements will be held on October 25 in Washington, DC, at the University of California, Washington Center.
Session topics include:
-Attention to Measurement in Clinical Trials
-Preparing the Groundwork for Clinically Meaningful Measurement
-Generating an Instrument with an Interpretable Score
-Incorporating a Well-defined and Reliable Measure into an Adequate and Well-controlled Study
“DIA invites patients and patient organizations to attend the Clinical Trial Endpoints Workshop to network with other stakeholders in the rare diseases community,” said program committee member Laurie Burke, MPH, RPh, Associate Director SEALD, Office of New Drugs, CDER, FDA, US.
Numerous regulatory and academia leaders will be chairing or presenting during the four dynamic sessions.
Session 1: Attention to Measurement in Clinical Trials: Why it Matters, will focus on good measurement principles, and be chaired by Laurie Burke. The session presenter is Marc K. Walton, MD, PhD, Associate Director, Translational Medicine, FDA, US.
Session 2: Preparing the Groundwork for Clinically Meaningful Measurement: Getting the Content Right, will focus on crucial information, including identification of the concept and patient population, recruitment of the correct range of patients, interviewing, qualitative analysis, item generation and tracking, and development of the draft instrument. The session will be chaired by James P. Stansbury, PhD, MPH, Endpoints Reviewer, Study Endpoints and Labeling Development Staff, CDER, FDA, US. Brian Taylor, Patient Advocate, Arthritis Foundation, will participate.
Session 3: Generating an Instrument with an Interpretable Score, will build on Session 2, exploring the questions and problems experienced during the building process. The session will be chaired by Jeremy Hobart, PhD, FRCP, Professor, Clinical Neurology and Health Measurement Peninsula College of Medicine and Dentistry, United Kingdom.
Session 4: Incorporating a Well-Defined and Reliable Measure into an Adequate and Well-Controlled Study, will review the vital design principles needed to improve key clinical trial tools. The session will be chaired by Robert J. Temple, MD, Deputy Center Director for Clinical Science, CDER, FDA, US.
Register for Clinical Trial Endpoints: Methods and Practice in Developing Measurements today.
DIA is a neutral, global, professional and, 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; Beijing, China; Washington, D.C; and Latin America. http://www.diahome.org. Follow DIA on Facebook, Twitter, LinkedIn, Flickr and YouTube. Stay updated on hot topic news at #druginfoassn on Twitter.