Transform Your Drug Safety Data And Adjudication Processes With Technology

How do you decide when a patient in a clinical trial has suffered an internal bleed or in another situation a heart attack? The answer to this question has historically been surprisingly elusive.¹

Research shows that clinical site investigators often differ significantly in their interpretation of even the most common of clinical events.² This is especially the case when clinical endpoints are subjective, image-based, or complex to assess. Examples of such endpoints include: cardiovascular events; pain, fatigue and depression; neurological scans; genetic information; incidence of infection or disease; disease severity and progression; and determination of cause of death.³ A number of studies have documented that disagreement between investigators in the interpretation of endpoint data can run as high as 10%.⁴

The ramifications can be serious: the larger the variation in clinical event data, the more difficult it is to identify treatment effects⁵. Inconsistent event data can jeopardize drug safety evaluations and significantly delay or even imperil regulatory approval of new drugs and medical devices^.6 Delays are costly—each additional month on a trial can cost hundreds of thousands of dollars.⁷ And keeping clinical trial costs in check is a top priority for most sponsors at a time when political pressure is growing to make healthcare and medicines more affordable and accessible^.8

Many may not know that cloud platforms can help streamline the clinical endpoint adjudication. Read below to see how these play a role in cutting costs, improving data quality, smoothing regulatory approval, and speeding time to market.