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Adapting to the Challenges of Cancer Clinical Trials

By September 2, 2009December 18th, 2023Awareness, Science & Research

Newspapers often comment on scientific journal reports, but it is not often the reverse happens. However this week a Nature Reviews: Drug Discovery (registration required) editorial highlighted an August 3rdNew York Times article on the challenges faced by clinicians in recruiting sufficient patients for cancer clinical trials. Thousands of cancer clinical trials are currently open, but only 3% of adults with cancer in the US are enrolled in a trial. This is slowing trial progress with some trials being halted due to lack of participants.  It is known there are various barriers that may impact recruitment – the time commitment required by the patient; the question of how the patient will benefit; and the cost and administrative burden to the clinic.

A couple of new approaches are endeavoring to change this. One is the ‘adaptive clinical trial’ model, where, rather than patients being assigned drug or placebo, or one of two drugs, over a long period of time, individual patient drug regimes are evolved and determined as data emerges from the trial – shortening the time of participation and potentially increasing the chances a patient might receive benefit. In another approach spearheaded by partners AstraZeneca and MD Anderson Cancer Center, the goal is to accelerate the time from drug being approved by the FDA for clinical testing (IND approval) to the first patient being treated.

It is anticipated these types of issues will come into play in NF trials as these trials increase in number and as the need for patient recruitment grows. One clinical trial approach currently supported by the Children’s Tumor Foundation, a Phase Zero NF2 trial of Lapatinib, is a type of adaptive model whereby the drug is delivered prior to vestibular schwannoma surgery and the tumor then analyzed. The goal of this study is to gain rapid information about the drug’s action in the tumor, and determin as rapidly as possible whether there is value in proceeding to Phase II clinical trials.

Another article on the topic of cancer clinical trials – a perspective from industry – is in today’s (September 2nd) New York Times.