The Cost of a Failed Clinical Data Strategy and How to Avoid It

Even more frustrating, the odds of success are stacked against them- approximately 90 percent of drugs that reach clinical development never make it to regulatory approval and marketization.Paul FardyVice President of Data Services, CROS NT Clinical drug trials can fall off track for many scientific...

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Bibliographic Details
Published inPharmaceutical Processing
Main Author Fardy, Paul
Format Trade Publication Article
LanguageEnglish
Published Rockaway Advantage Business Media 04.08.2017
Subjects
Clinical trials
Corporate sponsorship
Cost control
Hypothesis testing
Pharmaceutical industry
Recruitment
Regulatory approval
Technical communication
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Summary:Even more frustrating, the odds of success are stacked against them- approximately 90 percent of drugs that reach clinical development never make it to regulatory approval and marketization.Paul FardyVice President of Data Services, CROS NT Clinical drug trials can fall off track for many scientific reasons, though sponsors often associate trial delays with slow patient recruitment (more than 80 percent of trials fail to enroll on time). The common challenges they often face in data collection and reporting that lead to costly delays include: * Poor trial design and inconsistency with endpoints * Inconsistencies in trial data and failure to detect erroneous or fraudulent data * Failure to understand regulatory requirements and regulatory feedback * Dispersed data that can lead to inaccurate analyses or poor data quality * Vendor problems with staff and project team turnover While a “rescue study” might be necessary to save a clinical program, these studies...
ISSN:1049-9156