Published data indicate the size and complexity of these Phase III studies has hardly changed over the last few years.
R&D spending, according to a number of sources, continues to grow as biopharmaceutical solutions become integral to a wider range of medical maladies. Phase III clinical trials represent the critical data foundation in the new drug approval process for regulatory authorities around the world. Published data indicate the size and complexity of these Phase III studies has hardly changed over the last few years. Despite some assertions about a growing number of clinical trials, there are no data, which can be verified by third parties, supporting these assertions. In fact, one of the most widely accepted sources of data on clinical trials, ClinicalTrials.gov, points to an opposite conclusion.
ClinicalTrials.gov is a federal database, mandated since 2007 for all organizations conducting studies under FDA auspices. Missing data for any of the variables is often close to zero, and rarely exceeds three percent. ClinicalTrials.gov has become a widely used tool by drug development professionals and a frequently cited data source for research publications.
The randomized clinical trial (RCT) model has come under stress as the requirements of conducting RCTs became more demanding. As therapies become more targeted though, the financial calculus might very well make these RCTs even more problematic. Yet to date, the number of industry sponsored Phase III clinical trials continues unchanged. The slight drop in the 2016 reflects a slight lag in reporting.
Number of Industry Sponsored Phase III Opened in Each Year
Year
2014
2015
2016
Worldwide
892
902
808
United States
505
561
487
