Novel Early Phase Clinical Trial Design in Oncology

Early-phase oncology clinical trial design in the era of molecularly targeted therapy: pitfalls and progress

LBA4511 (2010). 3 Jassem J, Langer CJ, Karp D et al. Randomized, open label, Phase III trial of figitumumab in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin in patients with non-small celllung cancer (NSCLC). J. Clin. Oncol. 28(Suppl. 15), Abstract 7500 (2010). 4 Crown J, Dieras V, Staroslawska E et al. Phase III trial of sunitinib (SU) in combination with ca...

Clinical trial design in oncology: protocol design.

The protocol describes the objectives, design, methods, statistics, and organisation of the trial, as well as its background and aims—a good trial protocol addresses an important unanswered question. The type and phase of a clinical trial defines many specific parts of the protocol: clinical trials that include surgery or radiotherapy need indepth explanation of the procedures for quality assur...

Phase I Clinical Trial Design

Pharmacogenomics in early-phase oncology clinical trials: is there a sweet spot in phase II?

Many clinical trials of oncology drugs now include at least a consideration of pharmacogenomics, the study of germline or acquired genetic factors governing a drug's response and toxicity. Besides the potential benefit to patients from the consideration of personalized pharmacogenomic information when making treatment decisions, the incentive is clear for oncology drug developers to incorporate...

Unrealistic optimism in early-phase oncology trials.

Unrealistic optimism is a bias that leads people to believe, with respect to a specific event or hazard, that they are more likely to experience positive outcomes and/or less likely to experience negative outcomes than similar others. The phenomenon has been seen in a range of health-related contexts—including when prospective participants are presented with the risks and benefits of participat...