When a 500-Patient Study for $36M is a Bargain: True Cost of a Clinical Trial
(Friday, May 10, 2024) Clinical trials are the most expensive component of the overall cost of developing a new drug but there is little agreement on what a given trial should cost. Last month, Doctors Without Borders reported that it cost them $36 million to complete a 552-patient multinational trial indicating that the cost of the trials should be a lot less than what is projected by the drug industry but in the process seemingly supported the cost of trials projected by the drug industry. The cost of clinical trials depends on many definable factors such as the number of patients involved in this trial, the indication for the new drug, and the complexity of the trial design, and abstract factors such as the location of the trial sites, the profile of the investigators, and resources of the sponsor. Based on a survey of clinical trial costs reported by developers, a Phase II or Phase III clinical trial costs anywhere from $5 to $142 million. And since it could take multiple clinical trials to support market approval, the overall cost of developing a drug could run into hundreds of millions of dollars. The numbers proposed by Doctors Without Borders seem to confirm that. The TB PRACTECAL trial was aimed to evaluate a six-month regimen of three combinations of previously approved drugs for tuberculosis. The trial was conducted at seven sites in three countries – Belarus, South Africa, and Uzbekistan – that recruited a total of 552 patients over 4 years. The non-profit did a detailed breakdown of the cost of running this trial and reported that the total cost of this clinical trial was $36 million. They presented the tools used for calculating the budget for this trial. The clinical trial tool kit includes a detailed list of tasks, the resources needed to complete those tasks, and the associated costs. The Excel worksheet can be used to create the budget for any trial. Although $36 million may look like a bargain, especially when compared to the $1 Billion observational trial recently reported by the NIH, it is quite modest. There are several reasons why this price tag is not the cheapest for this kind of trial. This trial combined previously approved cheaper drugs, so the cost of the investigational product was low. The trial sites were located in countries where the cost of labor is lower, the study procedures involved routine tests available widely at reasonable prices, and the trial was run by a non-profit where the investigators and clinical teams likely worked at highly subsidized rates, if not for free. A similar commercially sponsored trial in the US or Western Europe would cost much more and would fall within the cost range supported by the drug industry. While overall the strong suggestion made by Doctors Without Borders that they did the cheapest cost-transparent trial can be challenged, the tool kit released by them is still an invaluable resource for clinical trial sponsors and project managers. ![]() AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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