Expert Insights

Expert Insights

Are You Asking The Right Questions to Determine Early Phase Oncology Trial Design?

Are You Asking The Right Questions to Determine Early Phase Oncology Trial Design?
04 October 2019

Clinical trial design is a critical factor that can make or break success. Careful foresight in this initial stage can impact data quality and trial duration to name just a few.

From randomization of patient groups, to blinding data to prevent bias, and use of control groups and placebos—there are numerous aspects to consider. Simultaneously, the changing oncology drug development landscape and growing interest in immuno-oncology treatments often requires different assumptions and factors to be tested than with traditional early safety-based trials for cytotoxic agents.

Ultimately, there is no one-size-fits-all solution when it comes to optimal clinical trial design. As such, conversations need to start early and often during protocol development among scientists, clinical leads, and statisticians to assess the best approach. Senior Biostatician, Christopher Tait recently addressed this topic and key factors for drug developers to consider in his blog on “Considerations for Designing an Early Phase Oncology Trial.”

Now, we delve a step deeper. From dose-efficacy to toxicity and enrollment, what questions should drug developers be asking in this important step? Download our latest checklist on 6 Key Questions to Ask in Assessing Early Phase Oncology Trial Design for important specifics. 

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