2014 Archived Content

Patient-Centered Technologies for
Post-Marketing and Real World Data Research

Enabling Non-Interventional Peri-Approval Studies
February 5-6, 2014 | Hyatt Regency Miami | Miami, FL 

Observational studies, registries and late phase trials tend to use particular technologies in order to generate unbiased data and so-called real world data. Electronic patient-reported outcomes, pharmacovigilance tools and other sophisticated technologies aim to reach a very important goal: to engage the patient in active participation in clinical trials. CHI’s 2nd Annual “Patient-Centered Technologies for Post-Marketing and Real Word Data Research” will discuss unique opportunities in observational research to examine the impact of a disease or treatment on patients’ life, preferences and healthcare choices.

Day 1 | Day 2 | Track Brochure | Full Event Brochure 


12:15 pm Bridging Luncheon Presentation between Technologies for Post-Marketing and Managing Post-Marketing (Sponsorship Opportunity Available) or Lunch on Your Own

Patient-Centered Research Technologies

1:20 Chairperson’s Opening Remarks
Kelly Hollis, MBA, Global Head, Surveys and Observational Studies, RTI Health Solutions 

1:30 KEYNOTE PRESENTATION: Innovative Research Tools and Solutions to Empower Patients

CraigLipsetCraig Lipset, Head of Clinical Innovation, Worldwide Research & Development, Pfizer

Topics to be discussed include: harnessing the power of social and mobile as key platforms to engage and inform patients and capture data during participation, sharing data to enhance the intersection of research and healthcare, and considerations when research participants are social.

1:55 Value of the Patient Voice in Non-Interventional Studies

Carla DeMuro, Head, Patient Reported Outcomes, RTI Health Solutions

The value of patient reported outcomes (PROs) extends far beyond traditional use in clinical trials offering unique opportunities in observational studies to examine the impact of a disease or treatment on how a patient feels or functions as well as to understand patient preferences and healthcare choices. This presentation will provide real-world examples of how PRO data provide important insight for patients, payers and prescribers.

2:20 Sponsored Presentation (Opportunity Available)

2:45 Using EHR Data for Non-Interventional Studies: How Good is Good Enough

MeredithNahmMeredith Nahm, Ph.D., Associate Director, Clinical Research Informatics, Biomedical Informatics Core, Duke Translational Medicine Institute

A major challenge in using EHR data for research lies in assessing the ability of the data to support research conclusions. This talk covers methods for assessing the quality of EHR data.

3:10 Refreshment Break in the Exhibit


Patient-Reported Outcomes And Beyond

4:00 Chairperson’s Remarks

4:05 Integrating Patient/Caregiver and Physician Surveys in Non- Interventional Studies: Survey Methodology and Best Practices

Kelly Hollis, MBA, Global Head, Surveys and Observational Studies, RTI Health Solutions

The discussion will focus on questionnaire development as well as selecting appropriate methods for the target population based on the content and objectives of the survey. Methods for designing patient and physician surveys to minimize bias and improve the accuracy and integrity of the data will also be discussed.

4:30 Technology Tools to Optimize the Management of Patient Reported Outcomes (PRO) Data

Denis Curtin, Ph..D.,CSO, Omniscience Mobile 

Keeping patients engaged long-term while collecting data in a secure validated manner are key making the most of PRO data. This session will explore the best tools and methods for leveraging technology in this space.

4:55 Innovative and Patient Centered Research Technologies in Late Phase Medical Device Clinical Trials

ChristinaVillarChristina Villar, MPH, Director, Clinical Affairs, Johnson & Johnson Vision Care, Inc.

This session will review ongoing efforts to engage patients in clinical development, initiatives such as e-consenting, direct to patient clinical studies, social media recruitment campaigns and other disruptive innovation that is being piloted across the industry. Companies such as Johnson & Johnson, Pfizer, and TransCelerate among others are evaluating new technologies to streamline the clinical research process while ensuring that data is accurate, real time, and patient centered.

5:20 Networking Reception in the Exhibit Hall

6:20 End of Day

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