Download Trimentum® Sequential Parallel Comparison Design

HELPING DELIVER LIFE-CHANGING THERAPIES
Trimentum®
Sequential Parallel Comparison Design
With experience conducting studies covering a broad
statistical power, which, in turn, can help manage cost and
range of neurological, psychiatric and pain disorders,
time. Use of Trimentum can—and has in several completed
PPD’s team of experienced drug development
trials—provide a large reduction in p-value if the drug or
professionals can expertly manage the complexities of
other therapy being tested is efficacious. Although this
your neuroscience trials. As part of our continuous effort
benefit is attainable whether placebo response is high or
to provide industry-leading neuroscience capabilities,
low, Trimentum can be particularly effective in psychiatry
PPD offers biopharmaceutical companies an innovative
studies, which typically have a high placebo response.
methodology for conducting clinical trials known a
s sequential parallel comparison design (SPCD), which
Enhancing Quality, Decreasing Development Timelines
PPD brands as Trimentum. This design was initially
and Providing Cost Savings
developed by researchers at Massachusetts General
Trimentum offers clients a cost-efficient methodology to
Hospital; assessments of this design have been published
address the concern of high placebo rates. Trimentum
by statisticians at the U.S. Food and Drug Administration
increases assay sensitivity and enables trials to be
(FDA). Applicability for use in registration clinical trials in
conducted using smaller sample sizes without impacting
depression has been successfully considered by regulator
the statistical power, providing cost and development time
stakeholders.
advantages.
Addressing Placebo Response
Drives Higher Efficiency
Many clinical trials for new psychiatric and pain drugs fail
• Trimentum can drive higher efficiency by requiring
to detect a statistically significant treatment difference
approximately 20-40 percent fewer patients, thereby
between drug and placebo. The most frequent cause of
reducing the number of investigative sites required,
trial failure, even for treatments known to be effective,
which, in turn, has the potential to lower the overall
is due to a high placebo response rate resulting in study
clinical trial cost
failure rates of up to 50 percent. As a result, false-negative
statistical results due to high placebo response can
• Months: Smaller studies mean shorter enrollment and
delay new medicines, increase development costs, label
accelerated development
effective treatments as ineffective, and reduce investment
in neuroscience research and development.
Reduces Time to Market
• Years: If failed trial is avoided
Improves Decision-making
• Robust data drives confident, clear decision-making
Current approaches to account for the effect of a high
placebo response are expensive and demonstrate
modest effectiveness. Trimentum serves to address the
concern of high placebo rates in clinical trials by using
two stages of treatment and enriching the primary
analysis population by re-randomizing subjects who are
placebo non-responders. Deploying Trimentum instead
• Fewer studies required to address development
objectives, thus reducing the size of the overall
development program
• Reduces the size of the overall development program
• Earlier go/no go decisions
Improves Assay Sensitivity/Data Quality
• Reduces risk of failure with higher quality; decreasing
of a conventional clinical trial design has the potential
the number of patients and sites required may
to reduce the overall sample size without impacting
decrease data variability
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