Pharmaceuticals
By mid-2016, over 6,300 products were in clinical development around the world. A single developed product may be used in multiple clinical trial projects for specific illness, so the 6,300 products corresponded to 9,526 projects in clinical development.
Oncology clinical trials accounted for over 4,000 projects in clinical development, while cardiovascular disease represented 455 projects. Approximately 739 projects were in neurology, including 143 in Alzheimer’s, 67 in Parkinson’s and 27 in ALS. Gene or cell therapy projects accounted for 731 projects around the world, while 173 projects were for developing DNA or RNA therapeutics. Projects using conjugated monoclonal antibodies accounted for 188 projects.
Of all projects, nearly 74% were potentially first in class, which is defined as “a unique pharmacological class distinct from those of any other marketed products.” The leading therapies that were potential first-in-class clinical-phase projects included cancer, neurology and diabetes, accounting for 79%, 74% and 69%, respectively.
It is estimated that of all compounds that reach the clinical trial stage, only 12% are approved by the FDA for therapeutic purposes, and that is after a 10–15 year period of development and over $2.6 billion on average in investment.
Due to a rise in procedures for Phase III protocols, which may adversely affect expenses and efficiency in drug development, industry, academic and government leaders have suggested new approaches, tools and methods to improve productivity. These include improving the validation of drug targets, as well as IT infrastructure and data analytics, and using new approaches, such as adaptive clinical designs, to increase the overall efficiency of clinical trials.
Source: PhRMA