Future Clinical Trials Are Here and How They May Succeed - Part 1 There has also been a drastic shift in clinical trial IT that is forcing not only biopharmaceutical enterprises, but also the FDA to rethink how we conduct clinical trials more efficiently. For instance, some IT systems offer advanced visualizations that incorporate public information with mapping technology and statistics for site feasibility selection. Other IT companies are implementing electronic consenting that enhances regulatory compliance by tracking patient behavior while reading, agreeing and signing the consent. Some biopharmaceutical enterprises are pushing the limits by interacting with the FDA in order to implement efficient and cost-effective virtual clinical trials. The Challenges Biopharmaceutical Enterprises Face Since many biopharmaceutical enterprises are pursuing patients with orphan/rare diseases, it is oftentimes difficult to find and enroll those subjects, as they tend to reside in remote regions, making site feasibility and selection not only difficult and wasteful, but also unsuccessful. For example, in cancer clinical trials, it costs approximately $50,000 to initiate a study site, and 20%-30% of study sites never enroll a patient [3]. In addition, 85% of cancer patients seek treatment at private oncology clinics, and only 50% of private oncology clinics conduct clinical trials, resulting in minimal clinical trial patient exposure [3]. Some biopharmaceutical companies have designed a disruptive concept surrounding how clinical trials would likely be conducted in the future.
Posted on: Tue, 02 Jul 2013 00:01:37 +0000
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