"CSA position continues to be supportive of pharmaceutical adjunct treatment that provides a low health risk to the patient, is reasonable in cost and provides high level of effectiveness for the majority of patients," states Executive Director Mary Schluckebier, BS, MA.
March 31, 2015 workshop addressed potential endpoints for registration trials in celiac disease. Stakeholders, including industry sponsors, academia, patients and FDA, addressed the challenging issues related to selection of endpoints and assessment methodologies in clinical trials intended to support approval of products for treatment of inflammatory bowel diseases and celiac disease.
Click on the following links to download presentation slideshows Celiac Day
Transcripts of the workshop will be available for review at the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and on the Internet at http://www.regulations.gov approximately 30 days after the workshop. A transcript will also be available in either hard copy or on CD-ROM after submission of a Freedom of Information request. Send written requests to the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. Fax requests to 301-827-9267.
Use of serology in clinical trials- FDA perspective,
Julia Tait Lathrop, PhD FDA:CDRH:OIR:DIHD
Clinician’s Perspective on Clinically Meaningful Benefit in Pediatric Patients,
Ivor D. Hill, MB, ChB, MD
Role of serology to measure clinical benefit and appropriate timing of assessment,
Daniel Leffler MD, MS
Defining Clinical Benefit in Clinical Trials- FDA Perspective,
Jessica J. Lee, MD, MMSc
Clinician’s Perspective on a Clinically Meaningful Benefit in Adult Patients with Celiac Disease,
Sheila E. Crowe, MD, FRCPC, FACP, FACG, AGAF
Clinical Outcome Assessment to Demonstrate Treatment Benefit- An FDA Perspective
Elektra Papadopoulos, MD, MPH
Role of Histology to Measure Clinical Benefit and Appropriate Timing of Assessment,
Benjamin Lebwohl MD, MS