PROficiency Educational Series
UPCOMING EVENTS
PROficiency 2012 Conference – PROs and Beyond
Date: April 17-19, 2012, Waldorf Astoria Naples
PROficiency 2012 - PROs and Beyond features international regulatory experts, biopharma professionals and industry experts presenting case studies and strategic and tactical information on the effective and successful use of OAs in worldwide clinical development programs. Attendees will network and learn from leading industry experts as they participate in general assembies and sessions following tracks pertaining to the scientific and operational aspects of OA data collection in both Phase 2/3 and late stage research.
Attendees will come away from the conference with knowledge of the scientific and regulatory considerations of capturing patient perspective in clinical development – practical input that can be used day-to-day in their clinical research. Don’t miss out on this must-attend event!
Using PROs to Optimize Comparative Effectiveness Trials
Date:
March 13, 2012 @ 11:00 AM Eastern
Presenters:
Dr. Jean Paty, Founder and Chief Regulatory and Scientific Advisor, invivodata, inc.
Frank J. Carillo, President and Managing Director, ECG, Inc.
Description:
Comparative effectiveness research is designed to inform health-care decisions by providing evidence on the effectiveness, benefits, and harms of different treatment options. Using Patient Reported Outcomes (PROs) to support comparative effectiveness trials is not only logical, but proves to be a valuable tool in helping researchers truly understand the effect of a medical product in the real world.
In this webinar, Dr. Jean Paty and Frank Carillo demonstrate how sponsors can leverage PROs in comparative effectiveness trials to determine a products’ therapeutic potential, define its competitive positioning, and optimize their payor reimbursement strategies.
DIA HOSTED WEBINAR: Using Patient-Reported Outcomes to Assess Comparative Safety and Tolerability: Methodological and Regulatory Considerations
Date: January 25, 2012 @ 11:00-12:30 PM Eastern
Presented by:
- Laurie Burke, MPH,RPh Director for Study Endpoints and Labeling, Office of New Drugs, CDER, FDA
- Ethan Basch, M.D., M.Sc., Associate Attending Physician, Department of Medicine Associate Outcomes Research Scientist, Department of Epidemiology and Biostatistics, Health Outcomes Memorial Sloan-Kettering Cancer Center
- Jennifer Petrillo, PhD, PRO Expert, Novartis Pharmaceuticals
Moderated by:
Chad Gwaltney, PhD, Senior Scientist, PRO Consulting
Description:
Comparing the safety and efficacy of new medical products to existing products can yield important information for all stakeholders in the healthcare industry. Patient-reported outcomes (PROs) may be used to assess the relative safety and tolerability of active treatments in comparative studies. This presentation, delivered through the Drug Information Association (DIA) will outline methodological and regulatory considerations when using PROs in this manner and describe applied examples.
For more information and to register, click here: http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?pr
PAST EVENTS IN 2011 SERIES
WEBINAR REPLAY: Are eDiaries Really Better than Paper?
Date: Friday, December 16 @ 11:00 AM Eastern
Presented by Arthur Stone, Ph.D., Distinguished Professor and Vice Chairman of the Psychiatry Department and Director of the Applied Behavioral Medicine Research Institute at Stony Brook University and Chairman of invivodata’s Scientific, Clinical and Regulatory Advisory Panel.
This webinar will review the rationale for trial participants recording assessments of their treatment-related experiences on a daily basis and what the clinical concerns are regarding the use of paper diaries. Dr. Stone will present information from his pivotal research on subject compliance with paper and electronic diaries, in which he conclusively demonstrates a significant degree of subject hoarding with paper diaries (British Medical Journal, 2002). He will then provide an update on the clinical development community’s reaction to these findings and how researchers are now approaching the collection of patient data in their efforts to evaluate the efficacy of new medical treatments.On October 19, FDA conducted a public workshop to discuss measurement principles for Clinical Outcome Assessments (COAs) used in clinical trials for new drugs. COAs include patient-reported outcome (PRO) measures, clinician-reported outcome (ClinRO) measures, and observer reported outcome (ObsRO) measures. The workshop outlined FDA’s expectations for the development and qualification to establish that COAs are fit for purpose and appropriate for their context of use.
DIA HOSTED WEBINAR: Using Patient-Reported Outcomes to Assess Comparative Safety and Tolerability: Methodological and Regulatory Considerations
Date: January 25, 2012 @ 11:00-12:30 PM Eastern
Presented by:
- Laurie Burke, MPH,RPh Director for Study Endpoints and Labeling, Office of New Drugs, CDER, FDA
- Ethan Basch, M.D., M.Sc., Associate Attending Physician, Department of Medicine Associate Outcomes Research Scientist, Department of Epidemiology and Biostatistics, Health Outcomes Memorial Sloan-Kettering Cancer Center
- Jennifer Petrillo, PhD, PRO Expert, Novartis Pharmaceuticals
Moderated by:
Chad Gwaltney, PhD, Senior Scientist, PRO Consulting
Description:
Comparing the safety and efficacy of new medical products to existing products can yield important information for all stakeholders in the healthcare industry. Patient-reported outcomes (PROs) may be used to assess the relative safety and tolerability of active treatments in comparative studies. This presentation, delivered through the Drug Information Association (DIA) will outline methodological and regulatory considerations when using PROs in this manner and describe applied examples.
For more information and to register, click here: http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?pr
WEBINAR REPLAY: Clinical Outcome Assessments – Review of FDA Workshop and Implications to New Drug Development
Original Date: Monday, November 14, 2011
On October 19, FDA conducted a public workshop to discuss measurement principles for Clinical Outcome Assessments (COAs) used in clinical trials for new drugs. COAs include patient-reported outcome (PRO) measures, clinician-reported outcome (ClinRO) measures, and observer reported outcome (ObsRO) measures. The workshop outlined FDA’s expectations for the development and qualification to establish that COAs are fit for purpose and appropriate for their context of use.
In this webinar, former FDA official Dr. John Powers and invivodata/PRO Consulting’s Dr. Jean Paty will review the key take-aways from the FDA workshop and discuss the implications to researchers using COAs in new medical product development. Specific focus on choice and development of different types of outcomes will be reviewed, including the importance of content validity, reliability, construct validity and other measurement properties for all types of outcomes that are strategic to product development.
Register for the webinar replay
WEBINAR REPLAY: PRO Regulatory Update: Migrating Instruments from Paper to Electronic Format
Original Date: Thursday, September 8, 2011
Presented By:
Celeste Elash, M.S., Scientific Consultant, PRO Consulting
Jean Paty, Ph.D., Chief Scientist & Regulatory Advisor, PRO Consulting
This webinar will focus on the necessary considerations when migrating a PRO instrument from a paper to electronic format. The presenters will discuss the regulatory recommendations and what needs to be evaluated to ensure there has been no impact on the interpretation and understanding of the instrument. The published industry best practices will be used as the basis of the discussion.
Register for the webinar replay
WEBINAR REPLAY: Leveraging the Internet in Clinical Research – Practical Applications & Considerations of Web-Based ePRO
Original Date: Tuesday, August 16, 2011
Presented By:
Dr. Brian Tiplady, Sr. Scientist, PRO Consulting
Ken Kolenik, Sr. Product Manger, invivodata, inc.
This webinar will focus on the use of the internet in clinical trials, primarily the use of internet diaries and questionnaires as part of clinical trials assessments. The presenters will review the key factors researchers should consider in determining the appropriate use of the Web for collecting Patient Reported Outcomes (PRO) data, methods for dealing with potential bias in internet samples, and the equivalence of internet-collected data to those obtained by other methods.
Register for the webinar replay
WEBINAR REPLAY: Interpreting Regulatory Feedback on PRO Instruments: Now What?
Original Date: Tuesday, June 14, 2011
Presented By:
Dr. Jean Paty, Founder and Chief Regulatory and Scientific Advisor, invivodata, inc. and Chief Scientist and Regulatory Advisor, PRO Consulting
Katarina Halling, Senior Scientific Consultant, PRO Consulting
You’ve diligently planned your PRO strategy. You thought you researched and selected the most appropriate PRO instrument for your program, or maybe you developed a new one based on FDA Guidance. You’ve communicated your plans with the Division and now – FDA requests additional information or changes to your PRO-based clinical development plans.
This scenario is not uncommon. Many biopharmaceutical researchers are surprised when FDA questions their PRO-based research strategies and don’t know how to interpret or respond to specific feedback.
In this interactive webinar, Dr. Jean Paty and Katarina Halling will review some common pitfalls of PRO-based research and offer direction on adhering to regulatory guidance. They will present examples of researchers who, upon receiving feedback from FDA, took appropriate steps to revise their PRO strategies to meet regulatory scrutiny and continue in their development plans.
Register for the webinar replay
WEBINAR REPLAY: Is Your PRO Instrument Ready for Regulatory Evaluation?
Original Date: May 26, 2011
Presented by: Dr. Jean Paty, Founder and Chief Regulatory and Scientific Advisor, invivodata, inc. and Chief Scientist and Regulatory Advisor, PRO Consulting
In this webinar, Dr. Jean Paty will review the important elements of PRO data collection pertaining to current regulatory expectations. He will review the steps clinical researchers should take in developing and implementing PRO strategies, so that, upon interacting with regulators, they will be better able to:
- Provide evidence that the symptoms being measured are important and relevant to the target patient population
- Defend how targeted concepts (i.e., subjects’ “pain points”) are linked to desired label claims
- Document that modifications made to an existing PRO instrument will not affect your ability to measure targeted concepts and endpoints
- Demonstrate the development history and performance of a newly developed PRO instrument
- Prepare for interactions with regulatory bodies on PRO strategies with confidence of a positive outcome
Register for the webinar replay
WEBINAR REPLAY: Value of ePRO Early in Clinical Trials
Original Date: March 1, 2011
Presented By:
Dr. Jean Paty, Founder and Chief Regulatory and Scientific Advisor, invivodata, inc. and Chief Scientist and Regulatory Advisor, PRO Consulting
In this webinar, Dr. Jean Paty discusses Improving Measure Sensitivity in Early Stage Research.
Also included is a review of the scientific and regulatory rationale for developing and validating PRO measures and implementing electronic PRO methods in Phase II clinical trials. Dr. Paty also covers the real-world value of using ePRO early in clinical development, including the practical benefits of justifying study investment to both internal and external audiences.
Register for the webinar replay – or - download the related article from Applied Clinical Trials
WEBINARS IN 2010 SERIES
WEBINAR REPLAY: ePRO Regulatory Environment in Europe
Original Date: November 11 & 16, 2010
Presented By:
Katarina Halling, Senior Scientific Consultant, PRO Consulting, a division of invivodata, inc.
Are you familiar with the current regulatory environment in Europe with respect to the use of electronic patient reported outcomes? Do you understand the expectations of agencies such as EMA? Join us for an interactive webinar that will explore various elements to consider for ensuring appropriate regulatory compliance when considering patient reported outcomes in your clinical research.
Register for the webinar replay
WEBINAR REPLAY & WHITE PAPER: ePRO - Focus on Site-Based Assessments
Original Date: October 26, 2010
Presented By:
Dr. Brian Tiplady, Senior Scientific Consultant, PRO Consulting, a division of invivodata, inc.
Ken Kolenik, Director, Product Management, invivodata, inc.
Site-based ePRO is not a recent innovation. The first reported use of a computer for collecting data directly from patients dates back to 1966. The devices may have changed over the years, but many of the same benefits and concerns remain 40 years later. In this webinar, Dr. Brian Tiplady with invivodata’s PRO Consulting division and Ken Kolenik with invivodata, will dicuss:
- Evolution of site-based PROs
- Benefits of implementing site-based PROs electronically
- Common concerns of electronic implementation
- Selecting and specifying a system for site-based PROs
- Current site-based ePRO technology
Register for the webinar replay – or - download the white paper
WEBINAR REPLAY: How do you know your drug works? Measurement is Strategic
Original Date: September 30, 2010
Presented By:
Dr. Jean Paty, Founder and Chief Regulatory and Scientific Advisor, invivodata, inc. and Chief Scientist and Regulatory Advisor, PRO Consulting
In this session, Dr. Paty discussed:
- How PRO instrument selection is strategic in drug development
- Essential considerations in developing a successful PRO strategy
- How your PRO measurement strategy can help differentiate your product
Click here to register for the replay of this webinar
WEBINAR REPLAY & WHITE PAPER: ePRO Regulatory Inspection Expectations – Be ready, be agile, be precise!
Original Date:June 24, 2010
Presented By:
Gretchen Craig, Manager of Quality Assurance, invivodata, inc.
Raymond Panas, PhD, Director of International Clinical Development, Sucampo Pharmaceuticals
Based on real-world ePRO experiences with regulatory inspectors, this webinar will identify the inspectors’ key areas of interest during an ePRO inspection. We will highlight a case study of an inspection along with recommendations on preparing for and supporting site and system inspections.
Click here to register for the replay of this webinar -or- download the whitepaper