Boosting Enrollment in Oncology Trials
The Need »
Figure 1. The
Sobering Facts
The National Cancer Institute (NCI) estimates that only 3% of adult
cancer patients in the United States participate in clinical trials.1
This is in spite of the fact that at any given time there are thousands
of ongoing clinical trials for cancer treatment.2 The low participation
rate among adults with cancer is a major impediment in developing
new cancer treatments, especially for rare indications.
In contrast to adults, children with cancer have a rate of clinical trial
SOURCES:
1. Gotay CC. Accrual to cancer clinical trials: directions from
the research literature. Soc Sci Med 1991; 33: 569-77
2. Crosson J Cancer Educ, 2001
participation of approximately 50%.3 This increased participation rate
accounts at least in part for the progress in treating pediatric cancers,
whereby 75% of children diagnosed with cancer today will be long-term
survivors.3 Clearly a key factor for better treatment and prognosis in
adult oncology lies in improved clinical trial participation rates.
Figure 2. Consequences
of Poor Enrollment
Consequences of Poor Enrollment »
The consequences of low or slow enrollment are clear. Without the
required enrollment numbers, the trial objectives cannot be met,
which could lead to abandonment of a promising compound. Slow
A CEI survey published in 2013 estimates that on
average a Phase III oncology trial costs $74,800 per
patient, a 90% increase from 2008
enrollment leads to longer study duration, and longer study duration
means increased costs and a delay in providing promising treatments
to patients. In phase III oncology studies, the cost per patient averages
$75,000,4 and in early phase trials the cost per patient averages over
$120,000. Within certain indications, the treatment landscape can shift
• New therapies can change standard of care
• Aspects of ongoing trial could become obsolete
quickly, and new therapies introduced during the course of a clinical trial
can change the standard of care and may make certain aspects of ongoing
trials obsolete or unethical. Slow enrollment can also lead to waning
interest and increased turnover on the part of investigators and their staff.
This results in having fewer experienced site personnel who are best able
• Many low-enrolling sites drop out of research after a few trials
• Many never get the necessary experience to be a “good site”
to communicate with patients about opportunities for trial participation.
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