Industry sponsored oncology clinical trials

Abstract

The US clinical trial register data was analysed to characterise industry and partially non-industry sponsored oncology clinical trials. The analysis found 2,248 trials with 45,882 study sites and 420,378 study subjects for industry-sponsored oncology phase I-IV trials on drugs and biologics. We previously reported that most industry-sponsored trials were in oncology, followed by CNS, cardiology, infectious diseases, endocrinology and respiratory diseases. We can now report that over the past two years the number of cancer trials and sites has increased proportionate by about twice as much as all other therapeutic areas combined. Oncology now accounts for 20.8% of all industry sponsored trials and 20.9% of all sites. Non-industry sponsored oncology trials account for 40.1% of all these, and 75.7% of sites. The total projected number of subjects to be recruited into industry sponsored trials – over 46 months up to July 2009 – is 4.1 million, compared with 1.8 million for non-industry sponsored trials. Prostate, breast, lung and colorectal-anal cancers have the highest incidence rate in the US, affecting between 72.0 and 50.6 per 100,000 population. They account for 54.6% of all cancer types and represent 49.4% of all industry sponsored oncology clinical trial subjects. Oncology trials are notably more global in nature than others. For instance, 45.8% of oncology phase III trial sites are global, compared with 32.2% for all other therapeutics areas. The corresponding subjects for recruitment are 37.7% and 28.2%, respectively. In conclusion, oncology has become the main focus of the industry in developing new medicinal products. This is because cancer is a leading cause of death and chronic in nature with a large market – the second largest by therapeutic area with positive year-by-year growth. At the same time, the industry faces strong competition to identify cancer trial subjects not just from its industrial competitors, but also from very popular investigator-initiated oncology trials. This explains why industry sponsored oncology trials are more globalised than other therapeutic area trials.