RESEARCH TRIANGLE PARK, N.C. – July 24, 2006 – Quintiles Transnational Corp. today announced the creation of the Strategic Biostatistics Unit to help customers cut the time and reduce the costs of drug development through the "adaptive design" of clinical trials and other innovative statistical approaches.
A study design is called "adaptive" if it allows modification of an essential design feature (e.g., sample size, randomization ratio, number of treatment arms), based on accruing data from within that clinical trial, with the possible adaptations fully pre-specified for confirmatory trials, and in all cases carried out without compromising the integrity of the trial.
"The FDA's Critical Path Initiative highlights adaptive design as one way to reduce the time and costs of clinical drug development while retaining the ability to reach good statistical decisions," said Stephen C. Smeach, Ph.D., Senior Vice President, Global Biostatistics & Medical Writing, Quintiles. "We're at the cutting edge with respect to adaptive design, both for Phase III and for Phase IIB-III trials. The FDA's facilitation of adaptive design methodology could in many cases lead to getting new medicines to patients faster and at less cost."
"Quintiles has already developed or implemented at least 10 adaptive designs within the last few years," said Jonathan R. Smith, Ph.D., Vice President, Strategic Biostatistics Unit, incorporating one or more of the following elements:
- Sample size reassessment, e.g., to compensate for variability larger than anticipated and thus improving the chances of a statistically successful trial;
- Combination of the Phase IIB dose selection stage with the Phase III confirmatory stage to produce a seamless Phase IIB-III trial, which can save substantial development time;
- Bayesian adaptive design features that can save time and cost by incorporating data from earlier trials (or from earlier stages of the current trial).
Quintiles also has developed or implemented many traditional group-sequential designs that incorporate:
- Stopping a clinical trial for futility, to cut costs when there is little chance that a statistically significant result can be obtained;
- Stopping for early demonstration of efficacy, which can save both time and cost.
The members of the Strategic Biostatistics Unit (Smith; Jorgen Seldrup, Ph.D.; Michael O'Kelly, Ph.D.; and Zoran Antonijevic), based in the U.S. and in Europe, have an average of more than 20 years of experience and provide input to sponsors on innovative statistical approaches to cut time, decrease costs or increase chance of success for individual studies or for whole programs. The group also provides a corresponding service for Quintiles' strategic investment unit, NovaQuest.
Quintiles is the global leader in pharmaceutical services, improving healthcare worldwide by providing innovative, quality professional expertise, market intelligence and partnering solutions to meet the dynamic needs of the pharmaceutical, biotechnology and healthcare industries. Quintiles has 16,000 specialized employees and offices in more than 50 countries. For more information visit the company's Web site at www.quintiles.com.