How to craft responsive clinical trials that are designed for success

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Without the right design, right data and right decisions, idealised clinical trial plans cannot be translated into blueprints for robust studies.

Designed For Success: Getting Clinical Trial Data And Decisions Right, a new white paper from Cytel, looks at how to increase a clinical trial’s chances of success amidst an evolution of the traditional three-phase development process.

While big late-stage trials are still fairly common, it’s also no longer a surprise to see sponsors refer to phase 1/2 trials, or phase 2/3, and smaller trials that can be progressed to the next phase if an interim data readout supports further evaluation.

Such ‘seamless’ trials and options like adaptive clinical trials can all increase a study’s chances of success. But only if it has the right design.

It’s a vital issue that pharmaceutical and biotech companies alike must address. Rebuilding and re-running a trial is a costly, time-consuming process that’s all too often avoidable if uncertainties in trial design can be resolved earlier on.

But, if failed trials are a major annoyance for big pharma, they can be fatal to smaller biotech companies, who don’t have the resources to cope with development processes that go wrong.

To explore these issues this report hears from Dr Charles Theuer, president and CEO of biopharmaceutical company TRACON Pharmaceuticals, four-time biotech chief medical officer Scott Harris and clinical development thought leader Dr Nico Merante.

Additional expert counsel is provided by Cytel’s senior vice president of clinical research services Irving Dark and its principal of strategic consulting Natasa Rajicic.

Together they explore the best ways of designing clinical trials for the life sciences sector with a rich, but increasingly complex data landscape, the role of real-world evidence and patient-reported outcomes, and how to craft the right clinical study design.

A key part of the process is knowing when to involve statisticians and patients in clinical trial design as part of responsive, intelligent study programmes.

The whitepaper can be accessed here or by clicking on the buttons above or below.