Expert Insights

Expert Insights

Successful Study Design in Precision Medicine

Successful Study Design in Precision Medicine
02 July 2020

The field of oncology has changed dramatically, with particularly rapid change in the past 10 years. Radiation began in the early 1900s, advancing to chemotherapy and hormone treatment in the 1950s. In recent years, immunotherapy and targeted medicines have quickly stepped up to take on the challenge, fueling the precision medicine market, which is anticipated to reach $85 billion by 2025.

But along with new therapies come new challenges and questions. Our Deb Kientop, vice president of oncology development, recently presented a webinar on The Progression of Targeted Therapies: Addressing & Surmounting Complexities in Clinical Development. Kientop discussed:

  • Evaluating and selecting optimal trial design
  • How to approach efficacy in later-phase trials
  • Biomarkers and companion diagnostics
  • Advancements in feasibility assessments

While there are factors outside study control that impact targeted therapy development — such as unclear or conflicting regulatory requirements between regions — there are controllable elements that can improve success, such as designing well-conceived trials, understanding the need for early development of biomarker and companion diagnostic strategies, and taking a data-driven approach to feasibility assessments and starting the process earlier.

Kientop discussed some of these, including:

  • Phase I trial design: finding optimal dose to move forward with and best study design — and why a 3+3 design might not be the best approach for targeted therapy trials
  • Identifying newer trial designs to facilitate development processes
  • Importance of running companion diagnostic development in tandem with therapeutic development
  • How to use data and technology to enhance feasibility assessments

COVID-19 has an impact on strategy that will undoubtedly continue as the global community emerges from shutdowns caused by the pandemic. But while some of the repercussions are negative, including delays in heavily impacted areas and reduced site resources, there are some positive ramifications, such as opportunities to incorporate innovation into operational execution.

More than one of every four medicines approved by the FDA over the past four years has been personalized treatment — an increase from 10 years ago, when it accounted for fewer than 10 percent. Patients are increasingly realizing the importance of therapies that are more likely to control or cure their specific disease and possibly reduce side effects. Precision medicine is a tremendous opportunity for sponsors, so designing trials to meet their needs — and help the patients who are waiting — is essential.

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