IQVIA helps navigate complexities and accelerate oncology research

As Korea's pharmaceutical and biotech industry accelerates its global market expansion, IQVIA Korea emphasized the importance of providing a unique and differentiated value proposition.

IQVIA is a clinical research service provider for the life sciences industry. 

Speaking at the IQVIA Insight Forum held at COEX, IQVIA Korea General Manager Chung Su-yong highlighted IQVIA's evolving role in connecting stakeholders within the research and development (R&D) ecosystem.

"We are considering how IQVIA can provide distinctive value amid diverse events," Chung said. He noted that the industry is now influenced by a wide array of players, including equipment companies, hospitals, investors, and patients.

This shift necessitates an understanding of these varied interests to offer tailored solutions.

Chung acknowledged the need to navigate these challenges through innovative business models that transcend traditional approaches.

"IQVIA aims to hold various forums to leverage its expertise to bridge the gap between fragmented data and insights to meet the evolving needs of a diverse and competitive industry landscape," he said.

At this year's IQVIA Insight Forum, experts discussed the rapidly changing landscape of early-phase oncology research and the urgent need for innovative strategies to expedite cancer treatment development.

Bryce Davies, Head of the JAPAC Early Phase Oncology, and Jose Luis Garcia, Senior Medical Oversight at the Oncology Center of Excellence at IQVIA, emphasized the critical challenges and opportunities in accelerating new therapies to patients.

Challenges and opportunities in early-phase research

Bryce Davies highlighted the intricate landscape of early-phase oncology research.

"Our environment is complex, with evolving study designs and innovative trial designs now standard," Davies said.

He emphasized how modern studies demand flexible and intricate protocols beyond traditional 3+3 models to identify maximum tolerated doses accurately.

"Trial designs are much more complex, and we need to operationalize them efficiently," he said.

Davies advocated for the adoption of innovative approaches like accelerated titration and Bayesian models, which can guide patients toward the optimal therapeutic doses necessary for robust efficacy data. He emphasized that the rise of cell and gene therapies further complicates the treatment landscape, necessitating the alignment of early-phase studies with this paradigm.

"We must ensure our early-phase studies fit into this paradigm," Davies said.

Additionally, regulatory agencies like the U.S. FDA and EMA are increasing scrutiny on dose optimization, pushing for minimizing toxicity while maximizing efficacy.

Davies pointed to Project Optimus and Project Front Runner, two FDA initiatives advocating early engagement with regulators to identify accelerated pathways.

Project Optimus aims to reform the dose optimization and selection process in oncology drug development by encouraging early consideration of pharmacologic and toxicologic data.

This seeks to balance efficacy, safety, and tolerability to reduce unnecessary toxicity in later-stage clinical trials.

Project Front Runner shifts drug development to focus on testing new oncology treatments earlier in the clinical course, providing access to safer, more effective therapies when they can significantly alter disease progression and improve patient quality of life.

Both projects emphasize the importance of optimizing dose and timing to improve outcomes and reduce adverse effects.

Garcia echoed these sentiments, stressing the urgency to identify and develop effective treatments quickly.

"Patients cannot wait, so we must identify the most effective medicines as soon as possible," he said. "We must adapt clinical trials seamlessly to reduce delays and bring new treatments to market."

Garcia underscored the significance of comprehensive preclinical data as foundational to defining accurate dosing in early-phase trials. "

This foundational modeling helps us understand dosing and toxicity, allowing us to define accurate starting doses for the first trials." Garcia said. "Inadequate dosing could result in ineffective treatment or excessive toxicity, requiring post-marketing trials to refine dosing further."

Optimizing clinical trial strategies

Both experts emphasized the importance of diverse clinical trials and effective site selection to yield representative data and improve patient outcomes.

"Ensuring adequate representation is essential to reflect cancer incidence rates accurately," Garcia said. "Effective recruitment, site management, and follow-ups are critical strategies for achieving trial diversity."

Garcia completed his presentation with three critical success factors in oncology clinical trials -- documentation, trial design, and diversity.

"We must learn from past experiences and adopt flexible trial designs to move quickly in developing effective cancer treatments," he said.

Davies also advocated for continuous dose-escalation communication, emphasizing the need to engage regulatory agencies early for flexible development plans aligned with accelerated approval pathways.

"Dose-escalation communication should be continuous, with safety signals discussed openly and early," he said. "Expanding into emerging markets like Malaysia and Thailand offers opportunities for dose escalation due to higher patient incidence and fewer competing treatments."

This approach requires early dialogue with regulatory agencies to create a flexible clinical development plan, Davies added.

Davies also reiterated the importance of aligning early-phase studies with evolving therapeutic paradigms and optimizing dosing to ensure effective and safe treatments reach patients faster.