Webinar: Innovation in Oncology Clinical Trials

Navigating Regulatory Challenges, Optimizing Protocols and Breaking Access Barriers

In this webinar, learn from our regulatory and clinical research experts how personalized medicine and other innovative strategies have led to smaller study populations associated with higher uncertainty on the evidence base for approval and reimbursement decision-making, while at the same time, broad patient access and the external validity of the data need to be ensured. This force-field warrants clever thinking about study design and making adequate use of the evolving regulatory environment.

Our expert speakers discuss three challenging aspects of oncology clinical trials, including navigating the ever-changing regulatory landscape, key types of innovative study design for novel therapies, and patient access and diversity.

Watch now to gain valuable insights into how to optimize trial design, overcome barriers and adhere to the evolving regulatory landscape. Ultimately, this knowledge will contribute to equitable access to innovative treatments, improved trial efficiency, and enhanced patient outcomes.

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Meet the Speakers

Paula van Hennik

Group Head Medical and Regulatory Sciences
Robert Rachford

Vice President, Biostatistics and Programming

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Kimberly Futch

Director, Clinical Operations Strategy
Shelby Stillwagon

Vice President, Decentralized Clinical Trials

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Paula van Hennik

Robert Rachford

Robert Rachford (Bobbie) has 15 years of experience leading biostatistics, programming and data management teams in both sponsor and CRO settings for pharmaceuticals and medical devices. Bobbie has a master’s degree in biostatistics and several years of SAS experience programming both TLF output and CDISC compliant datasets (SDTM and ADaM).

Kimberly Futch

Shelby Stillwagon

Shelby started her career in academic research, then moved to the clinical site environment, working in oncology, and has spent the past 11 years focused on supporting and operationalizing Decentralized Clinical Trials. Since 2013, Shelby has worked with numerous sponsors across hundreds of clinical trials, where she has provided expert guidance on decentralized visit design and logistics. She has held multiple oversight roles, supporting global teams across a wide variety of therapeutic areas including rare disease, pediatrics, oncology, neurology, and infectious diseases. Her expertise lies in collaborating with involved stakeholders to build and maintain study-specific, quality-focused processes that support complex decentralized clinical trials.