Should clinical trials be flexible for more targeted drugs?

Dr. Marie-C-cile Le Deley, Associate Professor of Clinical Epidemiology and Biostatistics at the Institut Gustave-Roussy, Villejuif, France, believes that clinical trials for targeted oncology drugs should not be the standard multi-year clinical trial due to the specificity and individualization each drug takes on.  This could be achieved through smaller trials with less stringent evidence criteria.  According to News Medical, instead of one large clinical trial, many should take place, certainty is found through many clinical trials testing the drugs.

Le Deley also points out that since these are personalized medications treating the patients, there are lower chances of poor outcomes because of the cytotoxic methods that killed all cells.

She stated:
"We found that there were important gains in survival attributable to a strategy of conducting more trials with smaller sample sizes and relaxed evidential criteria compared with those required under traditional trial designs.  The downside of this approach is that we also reduce the certainty of the findings: we might select as a new temporary standard a treatment that does not work better than the existing best therapy, but the fact that we will conduct many more trials will allow such errors to be quickly remedied."

This November, IIR will be hosting Biomarker Applications For Improved Clinical Trial Outcomes, gathering the top minds from the oncology clinical trial industry to discuss best standards and procedures for conducting clinical trials in this space.  For more information on the speakers and the program, download the brochure here.

Do you agree with Dr. Le Deley?  Should clinical trials be flexible for the new targeted and personalized oncology treatments?