Taking the Guesswork Out of Feasibility Assessment in Oncology Clinical Trials

Data Leads to Greater Predictability, Speed and Savings for Sponsors

The scientific progress being made in cancer research has never been more encouraging or more rewarding. Yet, virtually all oncology drug sponsors face an uphill battle in what one would expect to be the easiest part of the research process: recruiting patients for clinical trials. Despite the seriousness of the diagnosis—or perhaps because of it—only three percent of adult patients with cancer participate in clinical trials. As a result, under-enrollment is common.

Too many sponsors know firsthand the downside of over estimating how quickly an oncology trial can be enrolled. From the operational costs of rescuing or extending a trial to the lost opportunity cost of delayed market entry, the financial ramifications can be astronomical. If patient enrollment is difficult, forecasting patient enrollment is even more so. In general, the methods sponsors use to forecast enrollment aren’t very accurate, especially in oncology trials.

For better trial predictability, shorter timelines and meaningful cost savings, sponsors must take steps to ensure that their forecasts are realistic and achievable. In this session, the speakers will present an approach to forecasting enrollment in oncology trials. They will also share a case study with predicted vs. actual results.

Attendees will:

• Understand the unique challenges in forecasting oncology trial enrollment
• Learn best practices in identifying comparable trials for oncology benchmarking and planning
• Identify pitfalls in traditional enrollment forecasting processes and tools
• Learn about new tools and data sources being used to plan oncology trials

Speakers

Robert Millham, MS, MSc, PharmMed, Senior Vice President & General Manager, Hematology & Oncology, inVentiv Health

Bob Millham is the Therapeutic Area Leader for Hematology and Oncology. He has 17 years of Pharmaceutical industry experience, in roles including laboratory, clinical development and clinical operations. His most recent role before joining inVentiv Health was Vice President, Oncology Clinical Operations, in Pfizer Worldwide Research & Development. In that role, he oversaw the provision of operations support for clinical trials for Pfizer’s Oncology portfolio from phase I through IV. Bob was with Pfizer from 1998 through 2015, working in laboratories on biomarker development and validation. He joined Pfizer Oncology in 2004, and served in roles including Translational Medicine Lead, Clinical Lead, and Medical Team Lead before assuming his present role in Development Operations in 2013. Prior to joining Pfizer, he worked for companies in Biotech and Agri-Biotech. He is an author or co-author on eight peer-reviewed publications and over 20 peer-reviewed abstracts and presentations. He started his professional career as a high school chemistry and biology teacher, first in the suburbs of Chicago and later in northern Vermont. Bob holds degrees in biology (Middlebury College), microbiology (University of New Hampshire) and Pharmaceutical medicine (Hibernia College).

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JB Flinders, MPH, MBA, Associate Director, Feasibility & Clinical Informatics, inVentiv Health

As an Associate Director of Feasibility & Clinical Informatics at inVentiv Health, JB spearheads the use of innovative and specialized analytics, investigator and site relationships, and operational expertise to provide strategic, client-focused feasibility and site identification. JB has 10 years of experience across a variety of research fields, including a dedicated involvement to the oncology portfolio at inVentiv Health. He provides a unique perspective and proven success in strengthening cross-functional collaboration, including effectively leading internal teams, and Sponsor-CRO partnerships specific to Feasibility, Medical and Clinical Operations departments. He has presented across the industry, including at DIA. He also teaches Social Marketing and Health Services Administration; with special focus on quality, leadership and motivation, ethics, and risk management.

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