The era of personalised oncology is going to require new thinking from governments, companies and clinicians.
That is the view of experts at a meeting in Nice of the Cancer Biology for Clinicians Symposium organised by the European Society for Medical Oncology. They note that millions of cancer patients worldwide may soon be able to receive more effective, personalised treatments for their disease but "to make the most of this coming transformation, governments, pharmaceutical companies and doctors urgently need to adapt the way drugs are developed".__
Jose Baselga, from the MGH Cancer Center in Boston, USA, noted that cancer therapy "is arguably at the most exciting time in its history" and is at "the confluence of two new movements". These are "one toward personalised medicine and the other toward the use of new molecularly targeted cancer therapeutics that exploit the tumour's genetic and molecular signature". He added that these movements "provide many challenges, but also the opportunity for making paradigm shifts in the way we think of and treat cancer"._
Fabrice Andre, from the Institut Gustave Roussy in France, went on to say that "it is time to rethink whether the standard model of testing drugs in large Phase III trials is an effective way to bring these targeted cancer drugs to patients". He added that _regulatory processes "are becoming increasingly restrictive in providing patient access to potentially innovative new drugs, because even the largest cancer trials generally involve only a small portion of the cancer patient population".
Also the drug development process is often more than a decade from the first preclinical study, Dr Andre noted, and approval "usually needs large confirmatory trials that are being done in an unselected population". Therefore, there is a need for smaller trials done with selected patients to be highly sensitive, "a concept that requires the development of molecular selection and relative platforms for doing that".__
He concluded by saying that "it’s clear that we urgently need a new paradigm for drug development, including targeted patient selection for clinical trials, shorter duration of clinical trials and improvement of the cost-effectiveness of bringing a new drug to the market".