ISPOR Ninth European Congress Forum Presentation October 30, 2006
Patient Registries: Benefits and Key Challenges ∙The European Union Perspective ∙ Global Operational Issues
Moderator: Jeffrey Trotter MBA, President, Ovation Research Group, Highland Park, IL, USA
Speakers: David Schwicker, Managing Partner, OUTCOMES International. Basel, Switzerland; Gabor Vincze PhD, BS, MSc, Health Economic Manager, Novartis Pharma AG, Basel, Switzerland
Description: As new drugs and medical devices & diagnostics are introduced in multiple countries, the need to assess these health care interventions in a ‘real world’ environment is becoming more important. The use of monitoring tools such as registries, application-protocols, and post-marketing studies is increasing. During this forum the challenges in developing and implementing patient registries such as country-to-country cultural & language differences, patient confidentiality, registry implementation, and other issues will be discussed. The goal of the ISPOR Patient Registry Special Interest Group is to identify strategy and design issues relating to patient registries in specific countries and globally.

ISPOR 11th Annual International Meeting Forum Tuesday, May 23, 2006
Patient Registry Global Strategic Applications ∙ Developing and Implementing Patient Registries
Speakers: Leanne Larson MPH, Sr. Vice President, Patient Registries, Ovation Research Group, Highland Park, IL, USA; Melva Covington MPH, MBA, PhD, Team Leader, Global Health Outcomes, Eli Lilly, Indianapolis, IN, USA; Jeffrey Trotter MBA President, Ovation Research Group, Highland Park, IL
Description: A new registry assessment initiative has been launched by AHRQ to provide guidance as a part of the evaluation infrastructure developed to support MMA Part D. The focus of our SIG during the next year will be to evaluate how our SIG complements or overlaps with this larger effort and provide strategic recommendations to ISPOR leadership. We are preparing a White Paper to inform how best to develop and operationalize the use of patient registries. The team has had several meetings to discuss key issues regarding how registries are utilized in health outcomes and in the Pharmaceutical industry. We have approved the core outline for a White Paper, which can serve as a policy guidance document for ISPOR.  

ISPOR 11th Annual International Meeting Short Course Sunday, May 21, 2006
Patient Registries: Overview & Application
Faculty: Jeff Trotter MBA, President, Ovation Research Group, Highland Park, IL, USA
Course Description: This course is designed to provide an overview of patient registries and its applications in identifying 'real world' clinical, safety, and patient-perspective issues. The advantages and disadvantages of patient registry versus other “real world’ data collection will be presented. The course will address safety and clinical objectives, as well as regulatory trends and requirements. Key operational components and challenges, and measures of program success will be discussed. Management issues, including creating effective partnerships with patient-oriented organizations and facilitating long-term program operations within a changing organizational structure will be addressed. This course is designed for those with some or no experience with patient registries. http://www.ispor.org/meetings/phila0506/sc_sun.asp

Use of Patient Registries: Results of the ISPOR Patient Registry Special Interest Group Survey
ISPOR CONNECTIONS Vol.11 No 6: December 15, 2005
Authors: Elizabeth Molsen RN, Progressive Care Unit, Doylestown Hospital, Doylestown, PA, USA, Jeffrey Trotter MBA, Ovation Research Group, Highland Park, IL, USA, Marilyn Dix Smith PhD, RPh, ISPOR, Lawrenceville, NJ, USA
Description: The survey was developed to: a) assess the involvement of ISPOR members in patient registries, b) assess types of patient registries used, c) assess use of patient registries, d) assess use of standard operating procedures, and e) assess use of electronic data capture for patient registries. The results of this ISPOR Patient Registry SIG survey indicate that patient registries are used extensively by the outcomes research community with a growing need for them in the future. Disease-specific and country-specific patient registries were the most common type. Outcomes research and exploring ‘real world’ product use were the most common use of patient registries. The use of EDC is growing and SOPs are not common. https://www.ispor.org/news/articles/dec05/Patient_registries.asp

Utilizing Patient Registries to Support Health Economics Research: Integrating Observational Data with Economic Analyses, Models, and Other Applications
ISPOR CONNECTIONS Vol.11 No 5: October 15, 2005
Authors: Les Noe RPh, Leanne Larson MPH, & Jeffrey Trotter MBA, Ovation Research Group, Highland Park, IL, USA
Description: Patient registries have become a hot topic in today’s pharmaceutical, biotech, and medical device industries. Many companies have initiated them. Many others are contemplating them. But even with all the interest, there still exists much uncertainty around how to make the most of these important and complex programs. Much of a registry’s intrinsic value lies in its ability to address, in one comprehensive program, a variety of organizational objectives: collecting post-marketing safety information, gathering clinical effectiveness data, and understanding long-term outcomes, to name a few. Considered as part of an overall strategy to demonstrate value, data from registries may also be used to support other health economics/outcomes research (HE/OR) initiatives, such as cost-of-illness studies, economic modeling, and cost effectiveness analyses. https://www.ispor.org/news/articles/oct05/patient_registr.asp

ISPOR 10th Annual International Meeting Forum Presentation Monday, May 16, 2005
Patient Registries: Opportunity and Responsibility
Moderator: Jeffrey Trotter MBA, President, Ovation Research Group, Highland Park, IL
Speakers: Melva T. Covington MPH, MBA, PhD, Team Leader, Global Health Outcomes Eli Lilly and Company, Indianapolis, IN; Mohan Bala PhD, Director, Outcomes Research Centocor, Inc, Malvern, PA: Peter Malamis MBA, Vice-President & General Manager, Post-Marketing Business Unit, Scirex, Horsham, PA; Hugh Levaux PhD, CEO, Ninaza, San Mateo, CA; Leanne Larson MHA, Vice President, Strategy & Development, Ovation Research Group, Highland Park, IL, USA
Key issues were discussed, including the industry’s role in sponsoring post-approval registries that capture “real world” clinical, economic, and humanistic data and other evaluations critical for a more accurate characterization of how drugs and devices are utilized in actual medical practice. In addition, the findings from the Patient Registry survey will be presented and the Working Group Chairs will comment on issues involving commercialization, safety surveillance, analytical methods, technology, and global initiatives.