Electronic Health Records to Electronic Data Capture: Enhancing the Data Journey in Oncology Clinical Trials

The choices made in clinical trial setup — from patient recruitment strategies to data collection methods — directly impact the success and cost of a trial. Efficiency and data quality are crucial at every point in the drug development process.

The drug development industry has moved from paper-based data collection methods to the use of electronic data capture (EDC) systems over the past two decades. Subsequently, healthcare providers have moved to electronic health records (EHRs). There is significant value in linking these two technologies, and it is predicted that within five years, an EHR-to-EDC system will be a tool most research centers — even smaller trial sites — leverage to streamline and optimize their trial processes.

While EHRs and EDC systems are digital, the connection between them mainly is not digital but analog. This non-digital connection creates an opportunity for innovative approaches using technology to streamline trial processes better, enhancing data accuracy, reducing cost and expediting the development of new therapies. This directly benefits patient safety, trial accessibility, patient engagement and patient recruitment.

Register for this webinar to learn how to avoid any stumbles and how to prepare for and integrate EHR to EDC into your oncology clinical trial operations.

Speakers

Anthony W. Tolcher, MD, FRCPC, FACP, FASCO, Director of Clinical Research, Founder and CEO of NEXT Oncology

Dr. Anthony W. Tolcher is CEO and Founder of NEXT OncologyTM, a Phase I group that seeks to transform early clinical trials. NEXT has five sites, which include San Antonio, Austin and Dallas, Texas; Fairfax, Virginia; and two locations in Madrid and Barcelona, Spain. NEXT Oncology’s mission is to accelerate the next breakthrough medicines for cancer, and the vision is to be the most successful and respected Phase I program in oncology research. Dr. Tolcher served as President and Co-Founder of START LLC from 2009 to 2018, one of the world’s largest clinical Phase I and early drug development operations in cancer medicine with four locations, which include San Antonio, Texas; Grand Rapids, Michigan; Madrid, Spain; and Shanghai China.

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Dr. Tolcher is a medical oncologist with over 25 years of experience in early drug development and clinical trials. He has been involved in many of the initial Phase I studies of new agents that subsequently were FDA-approved for the treatment of cancer, including pembrolizumab (Keytruda), copanlisib (Aliqopa), trastuzumab emtansine (Kadcyla), regorafenib (Stivarga), liposomal vincristine (Marqibo), cabazitaxel (Jevtana), carfilzomib (Kyprolis), gefitinib (Iressa), erlotinib (Tarceva) and eribulin (Halaven). He is currently the Principal Investigator for 46 Phase I clinical studies and is a reviewer for the Journal of Clinical Oncology, Clinical Cancer Research and Annals of Oncology. He has chaired the Developmental Therapeutics Review Committee for the American Association of Clinical Oncology Annual Scientific Program. Dr. Tolcher has over 100 peer-reviewed publications in scientific journals, including Nature, Proceedings of the National Academy of Sciences, Journal of Clinical Oncology and Clinical Cancer Research, and is an author of nine book chapters.

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Andrew Zupnick, PhD, Vice President, Oncology Drug Development, Catalyst Oncology

Andrew Zupnick has focused exclusively on oncology for over 20 years and serves as the Vice President, Catalyst Oncology. He leads Catalyst’s full-service oncology solution, supporting study optimization, delivery oversight, training and new initiatives across the commercial and operational teams to keep Catalyst at the forefront of industry trends and cutting-edge oncology therapies. Andrew is a cell and molecular biologist with a PhD from Columbia University and a BS from MIT. Andrew began his professional career at Prologue Research, a niche oncology CRO, which was founded out of what became the James Cancer Center at The Ohio State University and acquired in 2010 by Novella Clinical. At Novella, Andrew led the growth of the organization’s oncology division into a market-leading oncology specialty CRO. After the acquisition of Novella by Quintiles, Andrew spent nearly seven years working within the standalone CRO subsequently rebranded to IQVIA Biotech in 2019.

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Craig McIlloney, Senior Vice President, Catalyst Flex

Craig McIlloney brings 25 years of experience in drug development with small and large CROs to his role with Catalyst. As Senior Vice President of Catalyst Flex, Craig is responsible for the global execution of functional services across multiple therapeutic areas. In his previous roles, Craig has overseen global operations across multiple functions, including but not limited to data management, biostatistics, statistical programming, medical writing, quality, analytics, systems and communications. This has included global expansion across multiple regions and his leadership experience spans activities across various delivery models, including FSP, full-service and hybrid models. He earned a BS (Hons) degree in Statistics from the University of Glasgow, UK and an MS in Applied Statistics from Napier University, Edinburgh, UK. He is a chartered statistician (Cstat) with the Royal Statistical Society and was previously a Director of the Statisticians in the Pharmaceutical Industry (PSI).

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Jackie Kent, Executive Industry Advisor

Jackie Kent is a global pharma executive, board director and advisor with a passion for working toward all patients having access to clinical trials. She has comprehensive knowledge of innovative healthcare technology, clinical trial design and execution, as well as clinical trial supply planning. She has developed innovative, transformative capabilities and has managed process innovation portfolio, building collaborative relationships and launching new IT platforms and strategies. She is deeply knowledgeable about the dynamics of diverse healthcare systems, GCP/GMP regulations, program development, clinical development and quality outcomes, and has experience with global regulatory agencies and the Society for Clinical Research Sites (SCRS).

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