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Making ePRO Easy Webinar Oct 2013

A desktop analysis...

Karen Briegs

on 29 May 2014

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Transcript of Making ePRO Easy Webinar Oct 2013

Patient Numbers & Distribution
Abilities & Burden
Making ePRO Easy
Take Inventory
Review your trial for elements that will affect the choices you make with ePRO such as...
Endpoint Goals, Study Objectives
Your Subjects, Visits and Procedures
Global Site Locations
Trial Start-up & Duration

Start-up & Duration
Tips and things to consider when planning a trial
with Clinical Outcome Assessments including PROs

Visits & Procedures
How are they impacted by disease or condition, age, mental acuity, sensory, dexterity

Acceptable for the disease/condition & the population to accommodate reasonably
Complexity of visits for sites, timing and order of procedures to meet protocol

Length of visit, duration of assessments, invasiveness (physical tests & assessments)
Per site, rate of accrual, staging, dropout/lost to follow up expectations,

Are patients clustered by region, are they rural or central
Trial Related
Initiation "runway" available
HA/IRB/EC requirements for review
Pre-study site evaluation findings

Long Term Environment
Cost of connectivity/technology
Technology maturation

Endpoint Goals
In the US and around the world the importance of patient-centric development is becoming more critical:
1995 - Formation of ISPOR
1999 - NICE was formed (UK)
2009 - Comparative Effectiveness
2009 - ISPOR ePRO Validation Paper
2009 - FDA PRO Guidance finalized
2010 - Formation of PCORI
2013 - FDA eSource Guideline Released
....What's next?

A Changing Paradigm



How do you
make sound decisions that will minimize operational impact
when selecting
an ePRO/COA solution?
Defining COA
Forms or ‘Instruments’ specifically designed for the purpose of collecting data that support claims of treatment benefit - the effect of treatment on how a patient survives, feels, or functions.

Types of Technology
Paper & Pen
Web Applications (IWR)
Handheld Mobile Devices
Proprietary Tablets/Devices
Commercially Available Tablets
Digital Writing
Subjects, Visits & Procedures
Phase of Study
Clinical Claims
and Labeling
Reimbursement Strategies
Licensing Models
Dennis Salotti
Director, Operations
P: 908-272-4787
F: 908-272-4631
20 Commerce Drive, Suite 125
Cranford, NJ 07016
Now you know what to look for...take a look at this!
A large body of evidence suggests that ePRO can be considered equivalent to PRO in many different computer based migrations - the level of testing you require should be based on:
Phase of Study
Type of Endpoint/Desired Outcome (Claim, Supplemental Data, Reimbursement)
Internal experience or standards
Published literature of same or similar COA migration
Karen Briegs
VP, Sales and Marketing
P: 908-272-4787
F: 908-272-4631
20 Commerce Drive, Suite 125
Cranford, NJ 07016
Full transcript