Coming up with a fair market value for a clinical trial budget that both sponsors and sites can agree on is difficult, as not everyone agrees what “fair market value” is. Some argue that the sites should focus on providing a solid defense for each expensive they expect a sponsor to foot; we should use the term “defendable market value” instead of “fair market value.” (CenterWatch)
Clinical trials have recently become very complex, especially for small and medium biotech companies, due to increased costs and regulatory requirements. Between 2008 and 2019, the cost of clinical trials increased by around 100 percent. In a 2018 study, a central cluster of trials had estimated costs of $12.2 million to $33.1 million. The trials cost a median of $41,117 per patient and $3,562 per patient visit. (Clinical Leader)
Biopharmaceutical manufacturers in 2017 invested approximately $15.2bn at clinical trial sites around the country – resulting in a total economic impact of more than $42bn, says PhRMA director of public affairs. (outsourcing-pharma.com)
Little is known about how trial site costs vary around the world. In this sample, most patients (60%) and sites (57%) enrolled were outside of North America. In Africa, Central Europe, Middle East, and Latin America, the cost per site was about 50% of the cost per site in North America. (PubMed)
A new study found the median cost of clinical trials in 2015 and 2016 to be $19 million, with a wide variation in costs. This study counters the assumption that elaborate and expensive clinical trials are the reason for the high costs of developing a new drug. Critics, however, argue that the study should not be misinterpreted as an estimate of drug development costs, as it has important limitations.