Rethinking Clinical Trials

The biomedical industry spends over $50 billion per year on research and development and produces some 20 new drugs. One reason for this disappointing output is the byzantine U.S. clinical trial system that requires large numbers of patients. Half of all trials are delayed, 80 to 90% of them because...

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Bibliographic Details
Published inScience (American Association for the Advancement of Science) Vol. 333; no. 6050; p. 1679
Main Author Grove, Andrew
Format Journal Article
LanguageEnglish
Published United States The American Association for the Advancement of Science 23.09.2011
Subjects
Biomedical research
Clinical trials
Clinical Trials as Topic - methods
Clinical Trials as Topic - trends
Databases, Factual
Electronic Health Records
Human subjects
Humans
R&D
Research & development
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Summary:The biomedical industry spends over $50 billion per year on research and development and produces some 20 new drugs. One reason for this disappointing output is the byzantine U.S. clinical trial system that requires large numbers of patients. Half of all trials are delayed, 80 to 90% of them because of a shortage of trial participants. Patient limitations also cause large and unpredicted expenses to pharmaceutical and biotech companies as they are forced to tread water. As the industry moves toward biologics and personalized medicine, this limitation will become even greater. A breakthrough in regulation is needed to create a system that does more with fewer patients.
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ISSN:0036-8075
1095-9203
1095-9203
DOI:10.1126/science.1212118