Navigating the complexities of oncology clinical trials in an increasingly competitive landscape

27 September 2021

FiercePharma

Advances in our understanding of the immunology, molecular and cell biology, and genetics of cancer are enabling the development of next-generation oncology therapies. With the shift from traditional chemotherapy agents to innovative immuno-oncology drugs and cell and gene therapies, clinical trials have increased in complexity. Greater competition, more sophisticated study designs, broader geographic scope, and increased emphasis on highly targeted patient subpopulations intensify the executional challenges of oncology studies.

Oncology is the fastest growing, most active sector of drug development. According to a recent analysis by the Tufts Center for the Study of Drug Development, the number of investigational oncology treatments has nearly quadrupled over the last two decades, from 421 to 1,489. The U.S. FDA’s commitment to prioritizing this therapeutic area is evidenced by the shorter regulatory review duration and higher likelihood of priority review status for oncology drugs.

Clinical trial durations, however, are 30 to 40 percent longer for oncology drugs due to protocol complexity and patient recruitment and retention. Oncology trials also generate a significantly higher volume of data than other drug trials and are more likely to have protocol deviations and substantial protocol amendments. [1] These extraordinarily complex studies require proactive planning and a deep understanding of the regulatory and competitive environment.

“In this new landscape, sponsors need a truly collaborative partner who can deliver the end-to-end clinical development, therapeutic, and regulatory expertise essential for running global oncology trials effectively,” said Ayesha A. Pandit, M.D., M.S., MBA, Vice President, Oncology Medical Strategy at Premier Research.

Premier Research is a leading provider of clinical research, product development, and consulting services to the biotech, specialty pharma, medical device, and diagnostic sectors, with notable experience in oncology. Their Built for BiotechSM platform is a commitment to helping transform life-changing ideas and breakthrough science into new medical treatments.

Supporting Oncology Innovators

Built for Biotech encompasses a comprehensive approach including a curated suite of resources that can uniquely benefit oncology-focused sponsors and global cancer patients and ensure consistent delivery of quality product-related outcomes. The platform opens seamless integration pathways for connecting product strategies, study designs, risk-based applications, and suppliers. It also pairs oncology development expertise with wide-ranging rare disease experience in the largest areas of unmet need—and fast-paced innovation—to provide sponsors with end-to-end visibility and greater control over the product development and commercialization process.

By engaging at the earliest stages of product development, Premier Research’s experts can help sponsors take advantage of novel adaptive designs that make studies more flexible and efficient. They are also well versed in remote and decentralized clinical trial approaches that reduce patient, site, and sponsor burden, improving the overall study experience. Beginning with the end in mind, Built for Biotech starts with oncology development strategy and regulatory expertise and finishes with product optimization and commercialization insights that help bring new treatments to the patients who need them most.

Accelerating the Path from Brilliant Idea to Life-Changing Innovation

Over the past five years, the experts at Premier Research have supported or managed more than 310 hematology and oncology projects, including more than 40 rare oncology and 19 cell and gene therapy oncology trials.

Premier Research leverages its global footprint to provide sponsors with greater access to diverse patients and enhanced study execution in some of the world’s fastest-growing regions for clinical development, including Asia-Pacific.

To address evolving sponsor needs and the growing prevalence of cancer around the world, Premier Research is investing heavily in its oncology capabilities. The organization has expanded its product development and regulatory consulting practice to include the full range of early-stage strategy, pre-clinical, submission management, and commercialization services. Premier Research has also increased its emphasis on oncology and rare disease patient access and engagement and invested in a new feasibility application to improve patient recruitment.

Their Premier One Ecosystem offers risk-based quality management to better integrate all oncology study data into a single platform for greater in-process analytics, communications, and reporting, allowing for hybrid and decentralized studies and remote monitoring. More recently, Premier Research has gained meaningful talent and expertise in non-interventional studies, such as real-world evidence, late phase, observational, and registry studies, which bridge the critical gap from development to commercialization.

“We offer a complete suite of services, from product development to regulatory strategies, led by experts skilled not just in all phases of oncology drug development but also the commercialization process,” said Krista Armstrong, Ph.D., Senior Vice President, Clinical Development Services at Premier Research. “Working with sponsors from the beginning, we’re able to better help them take advantage of adaptive designs that make trials more flexible and efficient as well as remote and decentralized clinical trial approaches that reduce patient and sponsor burden in an ever-changing clinical research landscape.”

To learn more, visit https://premier-research.com/learnings-insights/therapeutic-and-special-population-expertise/oncology-hematology/.


[1] Tufts Center for the Study of Drug Development. Protocol Complexity and Patient Enrollment Intensify Challenges in Oncology Clinical Trials, According to Tufts Center for the Study of Drug Development, May 4, 2021.

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