FOI release

FOI2024/01201: Oncology clinical trial approvals and excess costs

Some or all of the information requested was not provided because we didn't hold it.

Case reference FOI2024/01201

Received 2 December 2024

Published 21 February 2025

Request

Request received: 02 December 2024

Under the FOI Act, I would like to ask some questions about oncology clinical trial approvals and excess costs.

  1. Please provide a copy of your manual or standard approach for approving clinical trials in oncology. (For example, how they are scored and evaluated to secure funding).

  2. Please provide a copy of the standard process for approving clinical trials in oncology that exceed costs above £2 million. (Including whether there is ministerial involvement, or whether they have the power to overrule decisions.)

  3. Please provide me a copy of all correspondence you have received relating to excessive oncology clinical trial costs and getting them approved in the last 12 months.

  4. Please could you tell me how many clinical trials in oncology with excessive costs you have approved in the 12 months up to this request, versus the 5 years before it. And how many have not been approved. (e.g. 2024 = 20 yes, 10 no| 2023 = 15 yes, 5 no... etc.)

Response

Response sent: 20 December 2024

I can confirm that UK Research and Innovation (UKRI) does not hold information relevant to your request.

MRC has no role in approving clinical trials; this is the role of the Clinical Trials Regulator, the Medicines and Healthcare products Regulatory Agency[1] (MHRA). MRC reviews applications for research funding for clinical trials through the developmental pathway funding scheme (DPFS), where research funding is provided by MRC the necessary regulatory approval from the MHRA is then required before the study can start.

We have interpreted the reference to excessive costs as Excess Treatment Costs (ETC), and we would recommend contacting the National Institute for Health and Care Research[2][3] (NIHR) for further information. Briefly, ETC should be identified as part of the research funding application to MRC, and, if the research study is successful in receiving MRC funding, ETC payments for the study are paid for by the NHS. There are caps in place relating to the threshold of ETC that are not automatically paid by the NHS; the high cost threshold is £1 million per study and/or an average per patient ETC of £20,000. MRC would only be contacted if we had agreed to fund a trial in which the NHS subsequently refused to cover the ETC. This has not occurred since the high cost threshold was established in 2018, therefore, we do not hold any relevant correspondence in scope of question 3.

Regarding question 4, as stated above, MRC can fund clinical trials but has no role in approving clinical trials. Most of the clinical trials that the MRC funds are likely to have ETC associated with them. However, the presence or absence of ETC would not be a reason for MRC to reject a funding application for a clinical trial. Both funded and unfunded trials may contain ETCs, as every cancer patient put on a trial would be under NHS clinical care. We cannot provide any data that would answer this question, given that ETC are not a determining factor in the MRC’s decision-making process and MRC has no role in approving clinical trials.

Documents

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