“We are going to strongly reinforce FDA’s message about COAs in our webinar series with the goal of communicating the importance of having well-defined and reliable instruments and endpoints for the regulatory success of new medical products.”
NOVEMBER 2, 2011 –
Pittsburgh, PA (PRWEB) November 02, 2011 -- invivodata inc.®, the industry leader in patient reported outcomes (PRO) solutions and services for global clinical research, along with its scientific and regulatory consulting division, PRO Consulting®, today announced that it has extended its popular webinar series with additional educational events scheduled throughout the remainder of 2011 and 2012. The webinar series is part of PROficiency™ 2011 – invivodata’s annual educational initiative which provides researchers with current, practical information on effectively capturing patient perspective in the development of new biopharmaceutical products and medical devices.
The first program will review the key take-aways from a recently concluded Food and Drug Administration (FDA) public workshop on 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 webinar will review the FDA’s expectations for the development and qualification to establish that COAs are fit for purpose and appropriate for their context of use, and discuss the implications to researchers using COAs in new medical product development.
“We are very pleased to see FDA move toward the same expectations for all endpoints as PROs,” said Dr. Jean Paty, invivodata’s Co-Founder and Chief Regulatory and Scientific Advisor and Chief Scientist and Regulatory Advisor for PRO Consulting. “We are going to strongly reinforce FDA’s message about COAs in our webinar series with the goal of communicating the importance of having well-defined and reliable instruments and endpoints for the regulatory success of new medical products.”
The additional webinars involve collaborations between invivodata/PRO Consulting scientists and regulatory and industry experts on topics pertaining to practical and conceptual considerations of PRO and electronic PRO (ePRO) throughout clinical development. The new installments to the webinar series are:
- Nov. 14, 2011: “Clinical Outcome Assessments: Review of FDA Workshop and Implications to New Drug Development”; Presented by former FDA Official, Dr. John Powers and invivodata/PRO Consulting’s Dr. Jean Paty
- Dec. 16, 2011: "Patient Non-Compliance with Diaries: Paper versus Electronic Diary Methods"; 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
- Jan. 25, 2012: “ Using Patient-Reported Outcomes to Assess Comparative Safety and Tolerability: Methodological and Regulatory Considerations”; Sponsored by the Drug Information Association (DIA) and presented by Captain Laurie Burke, Associate Director, Office of New Drugs, Center for Drug Evaluations and Research (CDER) and Director, Study Endpoints and Labeling Development at FDA, Dr. Ethan Basch of Sloan Kettering, Jennifer Petrillo of Novartis Pharmaceuticals and moderated by Dr. Chad Gwaltney of PRO Consulting
For additional information or to register for any of the Webinars, please visit http://www.invivodata.com/eweb/
invivodata is the only fully-integrated PRO Solutions Organization delivering regulatory-proven strategic consulting and practical ePRO solutions to biopharmaceutical companies who depend upon patient-centered research. From crafting PRO measurement strategy to collecting PRO data electronically, invivodata helps its customers strategically use patient reported data to support labeling claims, enhance market access, and meet other clinical program objectives. Through partnerships with leading CROs and eClinical technology providers, invivodata seamlessly integrates into the clinical trial ecosystem, helping to minimize operational risk and maximize efficiencies. invivodata’s solutions have been used in over 350 clinical programs and are built upon the industry-leading ePRO system in delivering primary efficacy data for global drug approvals. invivodata inc. is a privately held company with global headquarters in Pittsburgh, PA., USA; its European headquarters is in London, England; and its technology development center is in Scotts Valley, CA., USA. For more information, visit http://www.invivodata.com.
About PRO Consulting
PRO Consulting, a division of invivodata, inc., provides consulting services to help clinical research teams effectively develop, execute, and document patient reported outcome (PRO) strategies to support their clinical research objectives. The PRO Consulting team has worked on over 150 clinical studies in 50+ indications, has more than 265 years of cumulative experience in psychometrics, PRO study design, and migrating and validating electronic solutions to collect PRO data, and has extensive experience working with the FDA and other regulatory bodies. For more information please visit http://www.patientreported.com