Quintiles to offer new biostatistics services
that it claims will help pharma firms cut the time and cost of drug
development through the "adaptive design" of clinical trials.
The move comes as the US Food and Drug Administration (FDA) has signalled it will soon release new guidelines allowing this new "adaptive" approach to clinical trials for the first time.
A study design is called "adaptive" if it allows modification of an essential design feature, such as sample size, randomisation ratio or number of treatment arms, based on accruing data as the trial progresses, with possible adaptations fully pre-specified for confirmatory trials.
In effect, clinical trial sponsors will soon have the flexibility to examine early results of a trial half way through and modify the trial design in order to improve the chances of a positive result, or cancel the study if it appears ineffective.
"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 Smeach, senior vice president of Global Biostatistics & Medical Writing, Quintiles.
"We are at the cutting edge with respect to adaptive design, both for Phase III and for Phase IIB-III trials."
The firm said it has developed or implemented at least 10 adaptive designs within the last few years including elements such as sample size reassessment to compensate for variability larger than anticipated; combination of the Phase IIB dose selection stage with the Phase III confirmatory stage to produce a seamless Phase IIB-III trial; as well as Bayesian adaptive design features that can incorporate data from earlier trials.
Quintiles said it has also been involved with many traditional group-sequential designs that have incorporated stopping a clinical trial for futility when there is little chance that a statistically significant result can be obtained; and stopping for early demonstration of efficacy.
All of these adaptations have the potential to improve the chances of a statistically successful trial and by doing so, save development time and money, said the firm.
While this may be true, the current industry guidelines were put in place to prevent any bias that could affect the outcome of a study and critics in the industry believe the FDA's allowance of the new adaptive approach could cause the integrity of trials to be jeopardised.
Acknowledging the concerns, Dr Scott Gottlieb, deputy FDA commissioner for medical and scientific affairs, admitted that adaptive designs could lead to "complicated decisions and uncertainty about the best approach for data analysis."
"It may also be true that making decisions during a trial's course can increase the rate of making an erroneous decision," he said.
The FDA said it plans to "address these concerns" and will be participating in a two-day workshop in November to "discuss all of the many issues around adaptive designs."
It is also planning to empower the data safety monitoring board or a similar expert panel to conduct an interim look at results and make decisions about how best to adapt a trial.
