MedicalResearch.com Interview with:
Thomas J Moore AB
Senior Scientist Institute for Safe Medication Practices
Lecturer, Department of Epidemiology and Biostatistics
The George Washington University
Milken Institute of Public Health
Alexandria, VA 22314
MedicalResearch.com: What is the background for this study? What are the main findings?
- The study provides realistic cost estimates of pivotal clinical trials that establish drug benefits to support FDA approval of 59 new drugs released for marketing in 2015-2016.
- The median estimated cost was just $19 million, with half of the 138 trials studied clustered between $12 million and $33 million.
- The highest cost trials–with estimates up to $345 million–were for new drugs that were similar to drugs already available and already proven in treating serious illnesses.
MedicalResearch.com: What should readers take away from your report?
Response: For the first time, readers can see what key clinical trials are now being required, and a realistic estimated cost of this key scientific evidence about drug benefits.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: What drug clinical trials costs should be regularly disclosed to permit wiser choices about how much drug testing to require.
MedicalResearch.com: Is there anything else you would like to add?
Response: Limitations are discussed at length in the paper. The most important are that these are estimated costs based on 52 variables–not the actual costs. Also the costs do not reflect all the clinical studies nor capture overall drug development costs.
Moore TJ, Zhang H, Anderson G, Alexander GC. Estimated Costs of Pivotal Trials for Novel Therapeutic Agents Approved by the US Food and Drug Administration, 2015-2016. JAMA Intern Med. Published online September 24, 2018. doi:10.1001/jamainternmed.2018.3931
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