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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 www.ppdi.com +1 877 6 GET PPD (643 8773) U.S. & CANADA © 2014 Pharmaceutical Product Development, LLC. All rights reserved. 08.2014 +1 919 456 5600 OUTSIDE THE U.S. & CANADA