Presentations and Podcasts
The scientific and regulatory experts of invivodata and our partner organizations routinely present information related to the capture of PRO data in clinical research. Click on any of the links below to access presentations, podcasts, and slides from recent conferences pertaining to current PRO and ePRO topics.
NOTE: Registration is required to download any presentation or podcast.
- WEBINAR REPLAYS
Are eDiaries Really Better than Paper? (original date: December 16, 2011)
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. Arthur 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.
Outcome Assessments – Review of FDA Workshop and Implications to New Drug Development (original date: November 14, 2011)
On October 19, FDA conducted a public workshop to discuss measurement principles for Outcome Assessments (OAs) used in clinical trials for new drugs. OAs 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 OAs 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 OAs 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.
PRO Regulatory Update: Migrating Instruments from Paper to Electronic Format (original date: Thursday, September 8, 2011)
In this webinar, Celeste Elash, M.S., Scientific Consultant from invivodata’s PRO Consulting division addresses the necessary considerations when migrating a PRO instrument from a paper to electronic format. She discusses 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 is used as the basis of the discussion.
Leveraging the Internet in Clinical Research – Practical Applications & Considerations of Web-Based ePRO (original date: August 16, 2011)
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.
Interpreting Regulatory Feedback on PRO Instruments: Now What? (original date: June 14, 2011)
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.
Is Your PRO Instrument Ready for Regulatory Evaluation? (original date: May 26, 2011)
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 and prepare for interactions with regulatory bodies on PRO strategies with confidence of a positive outcome.
Value of ePRO Early in Clinical Trials (original date: March 1, 2011)
Dr. Jean Paty will review the scientific and regulatory rationale for developing and validating PRO measures and implementing electronic PRO methods in Phase II clinical trials. The presentation will review 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.
ePRO Regulatory Environment in Europe (original dates: November 11 & 16, 2010)
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.
PRO: Focus on Site-Based Assessments (original date: October 26, 2010)
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 the 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
How do you know your drug works? Measurement is Strategic (original date: September 30, 2010)
This session covers, how PRO instrument selection is strategic in drug development, the essential considerations in developing a successful PRO strategy and how your PRO measurement strategy can help differentiate your product.
ePRO Regulatory Inspection Expectations – Be ready, be agile, be precise! (original date: June 24, 2010)
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.
FDA PRO Guidance Three-Part Series (click here to download entire series).
Part 1: Final PRO Guidance Insight from invivodata (original date: January 19, 2010)
Based on regulatory guidance, invivodata and our PRO Consultants will provide analysis and insight into the final PRO Guidance to help you understand what you need to do differently moving forward in your clinical research programs.
Part 2: How to Effectively Incorporate PROs into Clinical Trials (original date: March 4, 2010)
In this webinar, PRO Consulting’s Dr. Jean Paty will focus on specific implications of the final PRO Guidance and what it means for your clinical development program, including the design of your PRO measures.
Part 3: Implementing PROs into Clinical Trials (original date: April 13, 2010)
This webinar is the third part of invivodata’s 2010 PROficiency webinar series which focuses on the FDA’s final PRO Guidance. In this session, Dr. Jean Paty will review specific considerations that biopharma researchers need to keep in mind when implementing PROs in clinical trials. The webinar will focus on specific elements of PRO trial design, including blinding and randomization, missing data, and clinical interpretation of the PRO data. This will be followed by a detailed discussion on methods of PRO administration in the context of trial execution.
ePRO Industry Best Practice and Regulatory Considerations: An Update on Issues that Affect your Clinical Trials (original date: March 23, 2010)
Two important documents that directly impact the ePRO arena have recently been released: ePRO: Electronic Solutions for Patient Reported and the FDA’s final guidance on the use of patient-reported outcomes for labeling claims. In this seminar, scientists from invivodata and Perceptive Informatics will focus on several important ePRO topics discussed in these documents, including measurement equivalence for ePRO, reducing sample size via ePRO data integrity, migrating clinician instruments to ePRO, and user interface design issues for ePRO.
eDiaries: From Clinical Proof-of-Concept Through to NDA Approval (original date: December 3, 2009)
Clinical, operational, and regulatory issues involved in the use of eDiaries in the Phase II and III trials will be discussed, with an emphasis on lessons learned during clinical development and the NDA submission and approval process.
Supporting Regulatory Submissions and Inspections: The ePRO Perspective (original date: October 22, 2009)
This session will review the key areas of focus for ePRO submissions and inspections from the site, the sponsor, and the ePRO partner perspective. Topics include lessons learned on how to successfully prepare for and participate in ePRO inspections at the site-level and sponsor-level based on real experience and how to collaborate with an ePRO partner to support the inquiries.
Developing PROs: Common Pitfalls & Recent Experiences (original date: September 10, 2009)
The speaker will discuss some of the common pitfalls in developing PROs based on experiences over the last 3 years since the release of the guidance. Some examples will include: 1) lack of focus regarding specific claims in labeling, 2) getting in the game late – deciding to use a PRO late in the development of a medical intervention, 3) challenges in using previously published PROs starting with issues in content validity, and 4) approaches to determining the minimally important difference for a PRO.
Case Study: Developing and Acting Upon a Conceptual Model in the Context of a Global Drug Development Program (original date: July 30, 2009)
This case study discussed a project that was ongoing when the draft PRO guidance was published. We reviewed the process that was followed for development of a conceptual model, starting with a global workshop, and shared how the conceptual model has been implemented for this development program.
Improving Measure Sensitivity in Early Stage Research (original date: June 18, 2009)
Based on regulatory guidance, Phase II is the appropriate time to develop and validate PRO measures, making ePRO a logical fit earlier in the clinical development lifecycle. This session will cover the advantages of incorporating electronic PRO capture methods in Phase II or early stage development studies.
ePRO Regulatory Environment in Europe (original date: October 28, 2008)
An interactive webinar that explores various elements to consider for ensuring appropriate regulatory compliance in Europe when considering patient reported outcomes in your clinical research.
An Integrated Approach: Combining ePRO and EDC (original date: February 13, 2008)
Medidata and invivodata join forces to present and educational webinar about the benefits of integrating ePRO data sources with EDC systems.
Practical Implications of the FDA Draft PRO Guidance (original date: April 17, 2007) A Web Seminar discussing life after the FDA’s Draft PRO Guidance. Covered topics included: Meaning of “Conceptual Framework” as defined by the FDA; Best practices in defining a solid endpoint model; Necessary steps to determine the validity of a PRO measure; and, Practical steps to migrate from paper to electronic patient reported outcomes (PROs).
- PODCASTS
ePRO’s Impact on Clinical Trials
As one of PharmaVoice’s 100 most influential people in the industry, invivodata’s Dr. Jean Paty was questioned about how technology – specifically ePRO – has revolutionized the clinical trials process. This podcast shares Dr. Paty’s insights on how technology has advanced and improved new drug development and what he believes will be the next evolution in clinical data technology.
- MEDIA REPLAYS
NPR Broadcast: ‘Chippers’ Challenge Concepts Of Smoking Addiction
A number of surveys show that a substantial proportion of U.S. smokers don’t smoke every day. And their ranks appear to be growing. Up to 15 million U.S. smokers say they don’t light up on a daily basis. Many of them say they are trying to quit. But many light smokers — called intermittent smokers, or chippers — have no wish to quit. These are people who smoke no more than a couple of cigarettes a day, says Saul Shiffman, a professor at the University of Pittsburgh’s Department of Psychology. *National Public Radio, Morning Edition, January 22, 2009