Conducting clinical research is extremely time consuming given the extensive requirements necessary to begin a clinical trial. Protocols must be adhered to, results must be extensively recorded, and most importantly, patients must be protected complying with Section 312 of Chapter 21 of the Code of Federal Regulation. FDA estimates that is takes pharmaceutical and biological companies approximately 23 million hours each year to comply with the clinical trial requirements. After calculating the estimated annual burden, FDA found approximately 82% (19 million) of the total hours are spent on the reporting for human drugs.
Click here to read Alexander Gaffney’s article from RAPS.org.