Expert Insights

Expert Insights

Setting Up Your Early Phase Oncology Trial for Success

Setting Up Your Early Phase Oncology Trial for Success
26 October 2020

With more than 1,000 therapies in development for cancer — and with all therapies undergoing at least one, if not many, Phase I studies through the clinical development process — knowing the success factors in early phase oncology is critical.

Deb Kientop, vice president, strategic development, oncology, recently discussed this topic, in which she addressed:

Strategy Development

Beginning with a solid strategy influences the entire overall development plan. By determining — and making — better cumulative decisions in early phases of development, you’re increasing your chances of success.

  • Selecting the right study design. When is the traditional 3+3 not right for you? Are there more effective alternatives? And what should you take into consideration with targeted therapies and immunotherapy?
  • Lab and vendor requirements. As the industry has evolved, so have protocols. Trials today have multiple stakeholders and success can hinge on factors like choosing an EDC, identifying if central labs are needed and what imaging is required, as well as if any specialty vendors (such as one specializing in next-gen sequencing) will be needed.
  • Specific country and site considerations. In today’s global space, regulatory delays, variability in subject responses because of ethnic or genetic factors, and commercial considerations all need to be brought into your strategy development.

Site Selection and Management

Site consideration is important in every trial, but even more so in early phase oncology, and in our discussion, we expand on the important criteria, including:

  • Site consideration should go beyond just “large academic medical centers.” Selection criteria should be very specific to your trial.
  • Experienced Phase I oncology sites and investigators need to be committed to timely data entry and query resolution; knowledge of complex testing and treatment schedules; the ability to manage pK schedules; and more, for example.
  • Cohort management is critical; Deb shares a checklist of what to look for.

Team Expertise

All lead study team members need to be knowledgeable and experienced in oncology, of course, but Deb reviews some key areas in particular to focus on to help guide study success in the long term, sharing specific focus areas for each team, key indicators for success, and how to establish a robust oncology training curriculum that will keep everyone driving toward the same goal.

Operational Delivery

Getting to the results offered by an early phase oncology study is critical to most organizations, including go/no-go decisions for further clinical development, and often necessary to support corporate funding milestones. Any and all solutions for enabling rapid start-up and efficient delivery of the study can have a substantial impact. Deb also explores areas including:

  • Mapping out a complex early phase oncology trial. Deb shares her suggested process for incorporating critical information along estimated timelines and how to pivot when needed.
  • Managing data in early phase oncology.
  • Considerations for medical monitoring and safety.

With more than 3,600 Phase I oncology studies currently open for enrollment— about 40% of all currently enrolling oncology studies — knowing how to set your trial up for success is critical. You can watch Deb’s presentation here to learn more details.

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