Quintiles creates processes to reduce time, costs of clinical drug development

By Elaine Rigoli

Tampa, Fla., July 24 - Quintiles Transnational Corp. announced the creation of its 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.

"Quintiles has already developed or implemented at least 10 adaptive designs within the last few years," vice president of the Strategic Biostatistics Unit Jonathan R. Smith said in a news release.

The company said the process incorporates 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 2b dose selection stage with the phase 3 confirmatory stage to produce a seamless phase 2b/3 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 said it 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.

Quintiles is a pharmaceutical company located in Research Triangle Park, N.C.

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