There can be no doubt that drug development is getting harder – taking longer, costing more and with a declining rate of success.
Drug discovery employs some of the best brains on the planet and naturally there is an explosion of approaches to tackle this problem, in particular personalized medicine, translational medicine and drug combinations.
However unless our drug development can keep up and create compatible processes that can work with these ideas, the overall picture in the pharmaceutical industry will not improve.
Central to drug development is of course the clinical trial, and the biggest challenge in improving drug development is in changing the way we design and conduct clinical trials.
Better Trial Design
Better trial design offers a huge opportunity to improve the overall drug development process through the creative use of new trial designs. For instance, where conditions permit:
- Combining proof-of-concept and dose finding in the same trial, using early stopping for futility to limit the likely study size to little more than that of a stand-alone proof of concept trial if the compound is ineffective, but saving time and cost if there is evidence of efficacy.
- Studying two compounds in the same dose finding trial, adapting to not just the best dose but the best compound.
- Analysing a dose finding study using the Phase 3 clinical endpoint, but allowing the dose finding study to be terminated early if it fails to perform satisfactorily on one or more bio-markers.
- Studying a compound across multiple disease types (or subtypes) simultaneously, allowing its success or failure on types where results are quicker to inform your decisions as to whether to continue with the others.
- Comparing multiple doses in Phase 2 based upon their predictive probabilities in a Phase 3 randomized controlled trial.
Get your organization ready
The adoption of these techniques requires leadership and organizational change, because the current approach to trial design must be systematically challenged and alternatives evaluated.
- Watch this webinar to learn how Wyeth made this transformation. Watch the webinar
- Find out more about regulatory issues.
Learn how our services can help you get your organization ready for this change.