Clinical Development in the Precision Medicine Era

By Moez Benali, MD, PHd, Senior Medical Director, Fortrea

Oncology Clinical Development in the Era of Precision Medicine

The era of precision medicine is reshaping oncology trials, offering unprecedented opportunities to tailor treatments to individual genetic profiles. This transformation brings challenges in trial design and execution, and companies must adapt their clinical development strategies to stay ahead.

The Need for Targeted Personalized Treatments

Cancer is a complex and multifaceted disease, with numerous subtypes that vary in genetic makeup and behavior. While a traditional one-size-fits-all treatment strategy can be effective for some patients, it frequently fails to address the unique characteristics of individual tumors. Precision medicine overcomes this limitation by tailoring therapies to the specific genetic and molecular profile of a patient’s cancer.

Precision medicine is revolutionizing all stages of oncology, from early detection and localized treatment to managing metastatic and refractory cancers:

• In early detection, it allows for the identification of specific biomarkers, enabling timely and targeted interventions
• For localized treatments, precision oncology offers improvements by ensuring therapies are specifically designed to target the tumor’s unique genetic profile
• For metastatic cancers, precision oncology provides out-of-standard treatment options, allowing for more effective management of advanced disease stages
• In refractory cancer management, it aids in monitoring and adapting treatment plans based on the evolving genetic landscape of the tumor

Effects on Clinical Development

To bring the benefits of precision medicine to more patients, companies must adapt their development approach, streamlining the trial timeline with appropriate technologies and processes. While traditional drug development often spans over a decade, precision oncology can shorten this period to as little as 2.5 to 3 years by leveraging innovative trial designs. This is achieved by integrating multiple trial phases, from first-in-human (FIH) studies to registration, creating a more efficient path to approval.

Success in precision oncology trials hinges on several key elements:

• Innovative study designs that incorporate flexible methodologies
• Negotiation and collaboration with health authorities
• Effective patient recruitment, bolstered by robust clinical networks
• Strong clinical operations skills

Key strategies such as basket trials, dose escalation, expansion cohorts and enrichment strategies maximize efficiency and efficacy. These approaches enable researchers to evaluate multiple patient subgroups simultaneously, optimize dosing regimens more quickly and identify the most responsive patient populations early in the development process. The use of real-world data and external control arms have also become increasingly important in the design of precision oncology trials. These elements provide valuable insights into treatment effectiveness and safety, helping to bridge gaps between clinical research and everyday clinical practice.

Technological Advances in Precision Oncology

Advanced technology empowers precision oncology by enabling comprehensive evidence generation throughout the drug life cycle. By integrating real-world data, researchers can enhance trial design and outcomes, ensuring greater speed and agility. This provides broader insights to drive more effective treatments, enables identification of diverse patient populations to ensure inclusivity and enhances participation and retention.

AI and machine learning (AI/ML) innovations have the potential to further drive efficiency and precision throughout the trial design and execution. Key strategies include AI algorithms that match patients to high-throughput sites, multidimensional patient profiling and high-touch patient engagement through passive data capture from the Internet of Medical Things (IoMT). Additionally, tokenization and cloud-based computing integrate remote research ecosystems, ensuring data accuracy and consistency.

While leveraging advanced technology, collaboration with regulatory bodies including the FDA and EMA is essential. Precision medicine regulations are complex and continue to evolve with the introduction of new technology, and proactive engagement with relevant agencies can help streamline the process of bringing your therapy to market.

Looking Forward

At Fortrea, we are committed to supporting your precision medicine trial with customized, flexible solutions. From patient selection to biomarker validation, our comprehensive approach ensures compliance with key regulations, alignment with patient expectations and an optimized experience from beginning to end.

We strategically integrate the latest developments to enhance our approach. This includes exploring technology for real-time governance insights and participant engagement through AI chatbots. Data quality is also central to our future goals, including optimizing EHR access, expanding data collection to include patient-generated health data (PGHD) and actigraphy, and utilizing modeling and simulation across key areas. Through these developments, Fortrea is poised to lead the future of precision oncology clinical development.

Be sure you are prepared to meet essential challenges in precision medicine. Partner with us to discover how we can accelerate your trial timeline, ensure compliance and help you bring your innovative therapy to market.

Contact us to explore solutions to advance your precision medicine product development strategy