The capitalized cost to develop an approved new drug has doubled in a decade. Why?
First, growing complexity in clinical trial protocols makes it more difficult to manage studies efficiently. One measure of complexity – procedures per protocol – has increased by over 50% since the early 2000s. And more complex protocols take 73% longer to complete.
At the same time, the need for speed and quality in clinical trials has never been greater. Compromised data quality has prominently made recent front page news in the form of Theranos and other Silicon Valley sponsors facing significant challenges from the Food & Drug Administration (FDA).
And on the speed side of the equation, recent outbreaks – from Ebola to Zika – have placed a premium on speed. Disease tends to move with people across the interconnected world, eroding opportunities to isolate an outbreak and increasing the risk that it spreads more quickly.
Conventional clinical wisdom suggests that you can solve for speed or quality, but not both. On one hand, if you tighten timelines and accelerate decisions to more quickly complete a trial, you reduce the time and resources available to run the manual processes required to ensure clinical data quality. This approach brings drugs to market quicker, increasing the number of years for patent-protected sales (and patient access to the drug). But it also heightens the risk of poor data quality that may result in trial delays or action from the FDA.
On the other hand, dedicate time and resources to deliberately ensure clinical data quality, and slow down decision making – and, as a result, the trial. This reduces the risk of poor data quality – and potentially debilitating FDA action – but also reduces the time for patent-protected drug sales and potentially delays patient access to critical treatment.
But this is a false choice. Innovative new Clinical Intelligence technology – designed specifically for clinical teams – promises to accelerate trials while reducing the risk of poor data quality. Clinical Operators will no longer be forced to choose between delivering their trial on time or with high data quality. Instead, they can have both. Clinical speed and data quality have never been more important and more attainable.
The linchpin of Clinical Intelligence is accurate, up-to-date information on key aspects of the clinical trial. For most research teams today, data from disparate sources is manually compiled into reports that are outdated by the time they reach the Clinical Operations decision maker. The promise of Clinical Intelligence is to transform these disparate data sources into real-time insights that guide key decisions on resource allocation to meet critical trial milestones.
Armed with better and more reliable information, clinical teams make better decisions that accelerate clinical trials without compromising clinical data quality. Proactive and informed decision making reduces risk and the timeline to complete a trial. Clinical teams no longer have to choose between speed and quality.
The promise of Clinical Intelligence is to deliver life-saving drugs to market more quickly and without the risk of quality issues that compromise the treatment. In an increasingly mobile world with increasingly complex diseases, this technology is critical to meeting our evolving drug development needs.
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