Patient Centered Strategies for Clinical Trials & Treatment: Reactions to Payer Perspectives on Patient Reported Outcomes

Clinical Trials, Life Sciences, Medical Device, Medical Device Clinical Trials, Pharmaceutical, Pharmaceutical Regulation ,
  • November 10, 2016

Patient-reported outcomes (PRO) promise better information on the patient’s actual experience in drug trials and treatment, and they are now receiving close attention from regulators, industry, and patient advocates.

In May of 2016, inVentiv Health conducted a survey of managed market payers in the United States on the potential value of PRO in the evaluation of drugs. Despite the current focus on PRO including editorials in New England Journal of Medicine, Journal of Clinical Oncology, and JAMA Oncology, those surveyed express overt ambivalence about PRO as a decision-making tool, even in costly, hard-to-treat cancers. The full potential of a drug evaluation model that incorporates insights on the real-life patient experience hangs in the balance.

A follow-up roundtable, sponsored by Pharmaceutical Executive, was conducted to discuss the results of this survey in Chicago at the ASCO 2016 Annual Meeting. The discussions there revealed that leaders representing different segments of the industry were disappointed, but not surprised, by the survey results. Patients may not feel the issues that matter to them are acknowledged in the information hierarchy that dominates clinical decisions. Industry builds PRO data instruments with exhaustive patient input and focuses on collecting more than 85% complete data, yet payers feel that this data is spotty, inconsistent, and lacking impact on the costs of care. Thus the onus is on all of those entrusted with the execution of modern clinical trials—including regulators, industry, as well as the patient—to make the case for PRO through greater methodological clarity and better alignment with safety, efficacy, and other data assessment approaches like patient registries. If PRO can be effectively used to fully characterize the impact of new therapies, they will have a greater acceptance in drug evaluation by payers.

In this webinar, inVentiv Health shares data collected through a survey of managed market payers in the United States, and the potential issues and insights revealed at our ASCO 2016 Roundtable with Pharmaceutical Executive. We will discuss recommendations for how the industry will move forward to overcome the obstacles in the path of acceptance of PRO as an appropriate measure of the patient’s voice in cancer care.

Learning Objectives:

  • Learn about payer perspectives on patient reported outcomes
  • Identify potential conflicts caused by discordance between current payer perspectives towards PRO and other industry trends in favor of PRO
  • Identify potential strategies for increasing the acceptance of PRO measures in clinical trials and drug evaluation.

Speakers

David Thompson, PhD, Senior Vice President, Real-World Evidence, inVentiv Health

Dr. Thompson is a health economist with over 25 years of experience in the health economics arena, including work in economic modeling, retrospective database analysis, trial-based economic evaluations, and patient-reported outcomes. His work has been global in nature, with extensive experience in North American & European markets as well as the emerging markets of the Asia-Pacific and Latin American regions. Prior to joining inVentiv Health, he held leadership positions at Quintiles (2012-2016), i3 Innovus/OptumInsight (2000-2012) and PAI (1988-2000).

Dr. Thompson is a frequent presenter at and contributor to the International Society for Pharmacoeconomics & Outcomes Research (ISPOR), having functioned as Editor-in-Chief of Value & Outcomes Spotlight (formerly ISPOR Connections) from 2008 to the present, served as a leadership member of Task Forces for Good Research Practices on Indirect Treatment Comparisons (2009-2012) and Revision of the ISPOR Code of Ethics (2015-present), and led more than 30 workshops and issue panels at the International, European, Latin American, and Asia-Pac meetings. He has published approximately 50 articles in peer-reviewed medical journals.

Dr. Thompson holds degrees from the University of California Riverside (BS, Economics) and University of Massachusetts (MA, Economics; PhD, Economics).

Joseph O’Connell, MD, Vice President, Medical & Scientific Affairs, Hematology & Oncology, inVentiv Health

Dr. O’Connell completed his Medical Oncology Fellowship at Memorial Sloan Kettering, where his clinical development experience included work on Phase 1-3 studies in hematologic malignancies and solid tumors, and key studies in the development of effective anti-emetics to support delivery of chemotherapy in the outpatient setting. Thereafter, he practiced adult medical oncology for over 15 years in community and academic settings, the latter as a member of the Thoracic Oncology Clinic of Yale Comprehensive Cancer Center. Dr. O’Connell served as the president of the Connecticut State ASCO Affiliate, where initiatives included promoting payer and provider dialog on pay-for-performance initiatives and representing the Association in State Legislature testimony in support of access for underinsured patients.

Dr. O’Connell joined Pfizer in 2007 in Clinical Development, leading several Phase 1-3 studies for major late-stage assets. Responsibilities included formulation of clinical development plans, opinion leader engagement across North America, Asia and Europe, face-to-face global regulatory discussions, oversight of safety monitoring, input to commercial and market access efforts including launch planning, and participation in business development review. Thereafter, Dr. O’Connell worked in Medical Affair for Pfizer in a field-based role interacting with community and academic HCPs, US payers, and national pathway organizations.

Presently, Dr. O’Connell is VP/ Global Therapeutic Head, Hematology-Oncology division of inVentiv Health Clinical, a role which includes strategic input for large and small Pharmaceutical developers for Phase I-IV protocols, overall development plans, and support of market access discussions.

Heather Gartman, Managing Director, Patient Engagement Practice Lead, inVentiv Health

Heather has nearly three decades of experience in public relations and marketing communications for healthcare clients including Pharmaceutical and device manufacturers, patient advocacy groups, medical societies, trade associations and healthcare non-profits.

As the leader of inVentiv Health’s patient engagement initiative, Heather counsels bioPharmaceutical companies on successfully engaging patient and community voices at all stages of the development process from early stage clinical trials through to product launch. She has a passion for working in the area of rare disease, mental health and oncology and has worked in many rare disease states including Duchenne Muscular Dystrophy, Gaucher disease, Breast, prostate, thyroid, blood and ovarian cancer, Hunter Syndrome and depression. Recently she worked with a diverse group of advocacy organizations to develop the white paper, “Sharing the Mission to Conquer Rare Diseases.”

Heather joined as inVentiv Health PR’s DC Managing Director from Ruder Finn where she opened and oversaw the firm’s D.C. operations. Her efforts focused on strategic oversight for many of the firm’s global and US health care brands. She also has extensive experience in crisis and issues management including product and packaging recalls, scenario planning for failed products, product safety, patient issues and sales force infringement of ethics code.

Prior to Ruder Finn, Heather served as Managing Director and Head of Healthcare for Zeno Group in Washington, DC. In that role, she provided strategic direction for numerous award-winning public education campaigns including Know Your Stats about prostate cancer with the NFL, an asthma education campaign that included the writing of the children’s publication Breathless Bethany Buttercup, and If You Were My Sister breast cancer recurrence education campaign.

Heather resides in the Washington, DC suburbs where she enjoys spending her free time running, and being with her husband, Michael, and her identical twin daughters Hannah and Leah and son Ryan.

Kelly E. White, Director, Managed Markets Research, inVentiv Health

Kelly White leads Managed Markets research for iVH Research and Insights. She brings more than 13 years of experience working as both a managed markets consultant and strategic marketer in the Pharmaceutical field to this position, with a focus on combining her payer expertise and moderation skills with a strong customer focus to help clients solve a wide variety of managed markets research questions. Within the last five years, Kelly has conducted more than 1,000 payer interviews, and has led dozens of market access focus groups, workshops, and advisory boards. Prior to her marketing experience, she worked in the field of healthcare research for several universities as well as Kaiser Permanente. Kelly earned her Master of Public Health from the University of Michigan, her Master of Arts in health communication and consumer psychology from the University of Pennsylvania, and a BA in psychology from The University of Rochester.

Who Should Attend?

Clinical operations, data management and commercialization professionals from pharmaceutical, biotechnology, and medical device companies.

  • Managed Market Payers
  • FDA

Xtalks Partners

inVentiv Health

inVentiv Health is a global professional services organization designed to help the bioPharmaceutical industry accelerate the delivery of much-needed therapies to market. Our combined Clinical Research Organization (CRO) and Contract Commercial Organization (CCO) offer a differentiated suite of services, processes and integrated solutions that improve client performance. With more than 15,000 employees and the ability to operate in more than 90 countries, we enable clients to successfully navigate an increasingly complex environment. Learn more at inVentivHealth.com.

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