The commonly accepted figure for sales of a new drug is $1M per day. Thus, every day saved in bringing a new drug to market yields significant returns. As days turn into weeks, months, and years, the additional earnings add up and become massive. A few months can make the all-important difference between first and second to market.
The industry move from paper-based trials to electronic data capture (EDC) has helped shorten study timelines, allowing sponsors to cash out sooner on newly approved drugs. Furthermore, learning results earlier has helped researchers make more informed decisions when designing future trials.
Since the introduction of EDC, there have been major efficiency gains in processes at the end of a trial, such as data release and analysis. However, the industry is still developing a feel for how to reduce the amount of time necessary for study start-up. In some cases, use of standards and re-use of database specifications and objects can help accelerate study start-up; in others, over-enforcement of standards has slowed the development process and curbed creative problem solving. Also, reliance on the more established, traditional EDC systems tends to draw out the study set-up process. More nimble EDC solutions make it possible to set up your study in as little as a couple weeks.
Since Phase I studies generally include multiple small cohorts of patients that are deployed consecutively, these trials benefit especially from EDC systems that make it easy to implement mid-study database changes. Early Phase studies are the simplest and most common form of adaptive trials. EDC systems that allow for rapid study deployments can shave days or weeks off of each move to a new cohort. And EDC systems that allow for easy data review and analysis within the same system can further reduce time required for each cohort decision. In upcoming blog articles we will break this down into each component.
With billon dollar a year drugs on the line, you might assume that sponsors throw money at solutions to get their drugs on the market faster. However, this is not the case, as sponsors understand that just a small percentage of drugs in development will ever hit the market. Since clinical trials are not guaranteed to provide a return on investment, sponsors are motivated to keep costs as low as possible—whether choosing an EDC system or hiring a CRO. In addition to cost, quality of data, speed of set-up, and ease of use by sites are important factors to consider when evaluating an EDC system. More on that later.
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