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Abstract:
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In oncology trials, frequency of the assessment of schedule is usually determined by clinical factors such as common clinical practice, consideration of radiation exposure for patients, trial budget, etc. With progression-free survival (PFS) being accepted as a valid primary endpoint in many auti-tumor therapeutic product approvals, the interval censored time-to-event type of data are more common in the oncology trials. The frequency of the assessment schedule would unavoidably affect the accuracy of the estimation of median PFS with the standard statistical methods widely adopted in pharmaceutical industry. In this talk, we will run simulations to assess the bias that would occur from changing the assessment of schedule interval at some point in a trial and provide remedies by design and analysis.
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