Charging Patients for Participating in a Clinical Trial? FDA Clarifies Conditions
(Thursday, February 15, 2024) Clinical trial sponsors are responsible for paying for the cost of conducting the trial which includes paying for the use of clinics, hiring staff or vendors to manage the trial, collection and review of the data, regulatory approvals, and anything else that may be needed to properly run the trial. In some specific circumstances, a sponsor may be allowed to recover a portion of the cost from the patients participating in their trial. Last week the FDA released a Guidance Document describing those conditions. The investigational products being evaluated in clinical trials represent the latest scientific developments and hold promise to benefit patients in and for whom they are tested. This is particularly true for products in Phase 2 and 3 clinical trials. In those cases, the investigational products mostly have demonstrated potential to benefit patients with acceptable risk. It is well-established that patient volunteers in clinical trials get state-of-the-art medical care while in the trial. But often sponsors of clinical trials may be small businesses with limited financial resources. To encourage such sponsors to offset a portion of the cost of running a trial, the US regulations allow sponsors who meet the criteria of financial hardship, to recover the cost for the manufacture of the investigational product from the study participants. The law, however, requires the sponsor to create a clear and unambiguous justification for the financial hardship and get written permission from the FDA before charging the patients participating in their trials. The new Guidance Document is intended to answer common questions from sponsors about the process for FDA approval to charge patients. In their request for permission to charge patients. Sponsors must provide documentation to support their calculation for cost recovery. The direct cost of the manufacture of the investigational product such as the cost of components, raw materials, supplies, manufacturing process, and related activities are allowed to be recovered. The cost of investigational products that meet the definition of “extraordinary circumstances for manufacturing” as demonstrated in the financial documents are permitted to the recovered from patients. The documentation must be accompanied by a statement that an independent certified public accountant has reviewed and approved the calculation. Cost recovery is only allowed for investigational products for whom there is evidence that the drug has a potential benefit, has a significant advantage over available FDA-approved drugs, that the trial is essential to support FDA approval, and that the trial cannot be conducted without charging patients. The FDA would consider the financial resources of the sponsor in its review of the request for permission. Sponsors do not need permission to charge for drugs previously approved by FDA used in a new clinical trial is they are not the manufacturer of the approved drug, or if the drug is used for concomitant therapy. That the sponsors will need to present their complete financial information to the FDA has traditionally deterred most from asking FDA for this permission. Also, charging is not practical if the trial is blinded which most of Phase 2 and above trials are. Same rule for charging for investigational drugs applies to expanded use or compassionate use trials although it would be easier to do that since in those cases the benefit to patients is already agreed upon with the FDA. But in that case also, the need to disclose complete financials to the FDA may deter many sponsors from asking the FDA for this permission. AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: mkumar@fdamap.com Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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