TL31: Design of MTD Trials
*Nfii Ndikintum, inVentiv Health Clinical 

Keywords: "3+3", CRM, MTD, Oncology

In spite of its limitations, the "3+3" design to determine the Maximum Tolerated Dose (MTD) continues to be widely used in oncology trials. Researchers prefer this design for its simplicity and some assume the design to be safe. However, this design tends to yield a biased estimate of the target dose. The Continual Reassessment Method (CRM) is being adopted by researcher as an optimal approach to finding the MTD. The CRM design provides an unbiased estimate of the MTD. Some criticisms of the CRM include: large dose escalation steps might occur and patients could be exposed to dangerous toxic levels of treatment. The purpose of this roundtable is to discuss the merits and demerits of the “3+3” and CRM designs and their implementation in oncology trials.