Since 2004 numerous Phase III clinical trials have used Docetaxel as one part of clinical trials looking for survival advantage in men with advanced prostate cancer. More than half of the trials failed to produce positive results and others produced very weak results. The authors explore how and why this has happened.
Some trials produce 'statistical' success (e.g. significance) but not much 'clinical' benefit (e.g. a survival benefit of only a month or two). With such a high rate of Phase III failures, it makes sense to change the design of these clinical trials. The authors suggest:
1 Include the patient in the planning process. What do these men want and expect? What would be a positive outcome for them? What would make them want to volunteer for a clinical trial?
2 Identify and focus on patients most likely to benefit from a particular drug or treatment. Then design small studies including only those patients.
3 Determine what success is--improvement in survival, better quality of life, lower risk of toxicity, etc.
There have been too many failures in mCRPC phase III clinical trials to justify continuing the same procedures again and again. Trials are costly, patients are exposed to potentially toxic agents with little benefit, and marginally effective drugs may be moved toward approval. Studies should focus on providing the greatest likelihood of significantly improving the lives of patients.
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(c) 2012 Tom Beer and Larry Axmaker