We’ve seen an increase in new oncology drug approvals over recent years because of promising advances in personalized medicine and immuno-oncology. From 2011 through 2016, there were 68 novel therapies launched globally for the treatment of cancer. Currently, there are approximately 800 oncology drugs in development and more than 12,000 cancer clinical trials in progress.
Bringing these new drugs to market is costly; an estimated $2.6 million per approved drug, according to a 2014 Tufts study. Running clinical trials accounts for 60 percent of these costs. Why are oncology clinical trials, in particular, so expensive? For one, cancer patients often have advanced disease which presents challenges for their monitoring, ongoing care and logistics. From a trial design standpoint, the newer molecular targeted therapies require development, validation and adoption of new assays and methods of data management and analysis. Beyond that, sponsors need to adhere to an ever-changing global regulatory environment.
In our RFP Planning Guide for Oncology Clinical Trials, we explore key cost drivers for oncology studies, particularly for smaller and mid-sized sponsors. Here are a few that tend to create the greatest financial impact.
Project Management. Managing all aspects of a clinical trial can be an expensive line item, as it takes many experienced full-time employees to run a high-quality study. Other project management considerations include the number of hours and staff the project will require, the number of sites, global footprint, therapeutic complexity, speed of patient enrollment, the scope of services, and whether or not third-party vendors will need to be managed by the sponsor or a CRO. These factors can drive up costs if not properly addressed early in the planning process.
Patient Enrollment. Costs can quickly accrue based on the number of patients screened and enrolled in a study, the number of site visits required, and global variations in patient standard of care requirements. However, sponsors can plan visits and the associated site payments and payment report programming for efficiencies.
Data Management. Typically, data management costs vary depending on the number and complexity of case report forms (CRFs) per patient and associated edit checks, page/data volume, and variables such as data import/export volumes, and analysis numbers. Additionally, the number of CRFs affects other areas of the budget, including electronic data capture hosting costs, the number of data review cycles needed, specialized programming and biostatistics, and query volume reconciliation.
To learn about other key cost drivers and better understand the nuances of clinical outsourcing from a financial perspective, download a complimentary copy of the RFP Planning Guide today.
If you would like to speak with one of our oncology clinical trial strategists, please contact us.