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Low patient uptake leading to unsuccessful clinical trials: doctors


January 29, 2014
By Marilynn Marchione The Associated Press

clinicaltrialsJan. 29, 2014 — One of every 10 clinical trials for adults with cancer ends prematurely because researchers can't get enough people to test new treatments, scientists report.

The surprisingly high rate reveals not just the scope and cost of wasted opportunities that deprive patients of potential advances, but also the extent of barriers such as money, logistics and even the mistaken fear that people won't get the best care if they join one of these experiments.

"Clinical trials are the cornerstone of progress in cancer care," the
way that new treatments prove their worth, said Dr. Matthew Galsky of
the Icahn School of Medicine at Mount Sinai Hospital in New York.

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He
helped lead an analysis of 7,776 experiments registered on
Clinicaltrials.gov , a government website for tracking medical
experiments, from September 2005 to November 2011. All were mid- or
late-stage studies testing treatments for various types of cancer in
adults.

About 20 per cent of the studies were not completed for
reasons that had nothing to do with the treatment's safety or
effectiveness, both legitimate reasons for ending a study early. Poor
accrual — the inability to enrol enough patients in enough time to
finish the study — led to nearly 40 per cent of premature endings.

Company-sponsored
studies were less likely to be completed than those sponsored by the
government or others. Late-stage cancer trials can cost companies "tens
to even hundreds of millions of dollars," and that money is wasted if no
clear answer on the drug's value is gained, said Dr. Charles J. Ryan, a
cancer specialist at the University of California, San Francisco.

He
heads the program for a conference later this week in San Francisco,
where Galsky's study will be presented. It was discussed Tuesday in a
telebriefing by the American Society of Clinical Oncology, an
organization for doctors who treat cancer.

Ryan and Galsky said
they hoped the study would spur more research on why more patients don't
participate. In most cases, the treatment being tested is provided for
free, but there can be other costs such as lab tests. Some states
require insurers to cover these additional costs, but others do not, so
money may be one hurdle for patients.

Some doctors do not
strongly encourage patients to participate in studies, and sometimes
patients fear they'll get a dummy treatment instead of real medicine.
However, in cancer clinical trials, ethical standards require that all
patients get the current best care, plus a chance at an experimental
treatment.

"Patients still have concerns about getting a placebo,
but they're always going to get at a minimum the standard of care,"
said Shelley Fuld Nasso, head of the National Coalition for Cancer
Survivorship, a patient advocacy and education organization.

Doctors
need to encourage more patients to participate, and clinical trial
designers need to make sure they are testing key questions and
treatments to honour the contributions of study participants, she said.