Clinical Research Leaders Discuss Clinical Outcomes, Assessments And Technology At Boston Congress
8th Annual U.S. Patient Reported Outcome (PRO) and electronic Patient Reported Outcome (ePRO) Congress attracted global thought leaders engaged in clinical trials and late-phase studies.
Attendees of PHT's largest-ever annual PRO and ePRO Congress made it clear that PRO and ePRO are efficient, accurate, and economical methods to collect data within clinical trial research and post-market studies. The Congress gathered professionals from pharmaceutical organizations, regulatory agencies, CROs, Universities, technology providers and clinical sites to discuss and interpret the scientific, technology and regulatory aspects of PRO and ePRO data in research.
Brad S. Whitlow, Clinical Project Manager, Greer, said, "I enjoyed the meeting, and presenting my lessons learned using ePRO across several trials, as well as the lively discussion the talk generated. The breakout sessions I attended were very informative, especially the session on preparing for a successful regulatory inspection."
The agenda offered a mix of presentations, workshops and roundtable discussions including:
- ‘Using PRO for the First Time: Decide Which Modality to Use' – Christopher Cioffi Ph.D., Associate Director, Clinical Operations, Chelsea Therapeutics
- ‘Refining Data Management with ePRO' –Ivonne M. Falcon, Associate Director of Data Management, Neuroscience Product Creation Unit, Eisai Inc.
- ‘Patient Compliance and Burden Issues with PRO/ePRO' – Brad S. Whitlow, Clinical Project Manager, Greer Labs
- ‘CRO Perspective on Post-Approval Studies: Optimal Operational Factors Impacting the Collection of PROs' – Jeff Trotter, Executive Vice President, PharmaNet/i3
- ‘How CRO's Successfully Partner with ePRO Vendors' – Theresa A. Martin RN, PMP, Project Manager, Covance
"It was a great Congress and PHT did a wonderful job with not only the accommodations but also with the content of the conference" said Ivonne M. Falcon, Associate Director of Data Management, Neuroscience Product Creation Unit of Eisai Inc. Ms. Falcon continued, "My colleague and I learned many new ideas and concepts that can be useful to our company, and to go back to continue ‘pounding' on the importance of ePRO."
In an interesting discussion with regulators, attendees heard why clinical trial outcome assessments (COAs) are critical to understanding drug benefits and harms and reviewed regulatory expectations from sponsors in developing and analyzing their COA measures.
This year's Congress also included a spirited debate among sites, sponsors, regulators and vendors which revealed differing interpretations of PRO/ePRO issues. Participants actively discussed topics as: "What scientific value is conferred by ‘equivalency studies' that compare PRO scores of instruments administered using paper vs. electronic methods?", "Privacy vs. Attribution: If we can have both, why not capture names, emails, handwritten signatures, etc.?" and "Why are sponsors and sites still using paper?"
PHT President and CEO Philip Lee said, "We were extremely impressed by the level of knowledge, experience, and insights offered by Congress attendees throughout the meeting. PHT sponsors this event to enable members of the PRO and ePRO community to network and share ideas in a collaborative environment to collectively drive the use of PROs and ePROs forward. Ultimately, we all share the same goals of doing good science and bringing new therapies to market that treat disease and improve health."
PHT will host the European Congress in Annecy, France, June 12 -14. Please visit phtcorp.com for more information.
About PHT Corporation
PHT Corporation is the industry's only dedicated full-service ePRO provider. PHT offers clients a comprehensive solution for acquiring, managing and analyzing data collected directly from patients through all phases of clinical development. More than 115 biopharmaceutical companies use PHT's ePRO System to easily collect high quality, regulatory compliant clinical trial data. PHT's proven LogPad, NetPRO and versatile SitePad Systems deliver the voice of the patient, in 97 languages, from homes and sites in 67 countries around the world. Patient experiences captured firsthand by PHT's ePRO System have been used successfully in at least 19 regulatory submissions and 16 approvals to date resulting in 14 PRO-based label claims for sponsors. For more information, visit phtcorp.com.
SOURCE: PHT Corporation