Online Registration has closed. 

You may register by fax at 1-215-442-6199 through October 22. 

Onsite registrations will also be accepted starting Monday, October 26.

This meeting, sponsored by DIA’s new Study Endpoints SIAC, is contiguous with and co-located in the same city as ISOQOL’s Annual Meeting. It is a forum for interested individuals to drive the future direction of this new DIA SIAC.

Study endpoints used in clinical trials include, but are not limited to clinician-reported outcomes (ClinROs), patient-reported outcomes (PROs), and reports by caregivers and other observers of patient signs and behaviors related to health status. There has been significant discussion, but little consensus with respect to a common set of best practices applicable across all types of these report-based measures used as study endpoints in clinical trials. This conference brings together key stakeholders to discuss the conceptual, measurement, and practical issues regarding these endpoints when applied to product development. Specifically, the scientific and regulatory issues will be discussed when these types of study endpoints are intended to be used in support of medical product labeling claims.

The conference will begin with a set of presentations to set the context for and to provide a definition and overview of the range of study endpoints used in multinational trials. The conference will include presentations from representatives of the FDA and EMEA who will provide the multinational regulatory perspectives.

Subsequent sessions will include discussion of common principles for the development and validation of all study endpoint measures. The relationships between entry criteria and outcome measurement and between different types of endpoint measures will also be explored.

At the conclusion of this meeting, participants should be able to:

·         Distinguish between different types of study endpoints

·         Define the range of measure types used as study endpoints to support labeling claims in the US and EU

·         Characterize when ClinRO, PRO, Caregiver or other report-based study endpoint use is most appropriate

·         Explain how to implement ClinRO, PRO, Caregiver or other report-based study endpoints in multinational trials

This program is designed for

·         Biopharmaceutical and device clinical research physicians and medical product development teams

·         Clinical operations and global health outcomes teams

·         Instrument developers, investigative sites, and other study endpoints researchers

·         All clinical trial personnel

Event information: Joann Boileau at the DIA office by telephone +1-215-442-6175, fax +1-215-442-6199 or email Joann.Boileau@ diahome.org or Marjorie Davis at the DIA office by telephone +1-215-442-6176, fax +1-215-442-6199 or email Marjorie.Davis @diahome.org.

Tabletop exhibit information: Shannon Lewis, Exhibits Associate, at the DIA office by telephone +1-215-442-6149, fax +1-215-442-6199 or email Shannon.Lewis@diahome.org.

09025
Measuring Study Endpoints in Multinational Clinical Trials:
Outcomes Reported from the Viewpoint
of the Clinician, Patient, and Caregiver
(Tabletop)

	invivodata
	PA ,
	MAPI Institute/MAPI Research Trust
	Perceptive Informatics
	NJ ,
	PHT
	MA ,
	United BioSource Corporation
	MD ,

The most convenient airport is New Orleans International Airport and attendees should make airline reservations as early as possible to ensure availability. The Sheraton New Orleans Hotel is holding a block of rooms at the reduced rate below until October xx, 2009, for the DIA event attendees. Room availability at this rate is guaranteed only until this date or until the block is filled.

Single $205          Double $205

Please contact the Sheraton New Orleans Hotel by telephone at +1-504-525-2500 and mention the DIA event. The hotel is located at 500 Canal Street, New Orleans, LA 70130, USA

Register 3 individuals from the same company and receive complimentary registration for a 4th! All 4 individuals must register and prepay at the same time – no exceptions. DIA will apply the value of the lowest applicable fee to this complimentary registration; it does NOT include fees for optional events or DIA membership. You may substitute group participants of the same membership status at any time; however, administrative fees may be incurred. Group registration is not available online and does not apply to the already-discounted fees for government or charitable nonprofit/academia. To take advantage of this offer, please make a copy of this registration form for EACH of the four registrants from your company. Include the names of all four group registrants on each of the forms and return them together to DIA.