Grant Funding for Clinical Trials
Clinical trials are an important stage of R&D for new pharmaceuticals, treatments and medical devices, building up evidence for both safety and effectiveness in human participants. They are also required by regulators like the MRHA in the UK and the FDA in the US before you can start selling your new medical product. They can also be costly and time consuming, however, and you can expect to spend over £25 million to bring a medical product through all the required stages. Explore grant funding for clinical trials below and contact and FI Grants expert to start the process towards application.
What are the different stages of clinical trials?
Phase I
Clinical trials in this phase focus on the safety of the new treatment, looking at the maximum safe dose and the main side effects. They are usually carried out with a small number of participants (20-100) and last several months.
Phase II
This phase of the trials begins to look at how well the treatment works compared to a placebo (or the existing available treatments) in randomised trials with up to 300 participants.
Phase III
This phase takes these randomised trials to multiple test sites, with up to thousands of participants, and can take years to complete. These trials generate the efficacy data required by regulators and the safety information that is printed on labels and packaging of the treatment.
How much can I claim?
The average amount of funding given for projects involving clinical trials is ~£2 million. While this cost is below the average amount for Phase II (£6.6m) and Phase III (£16.5m) clinical trials, it could cover a large amount for smaller trials, improve cashflow, and can de-risk your technology for investors.
What competitions support clinical trials?
There are two main grant funding competitions for clinical trials:
Biomedical Catalyst
Innovate UK’s flagship health and healthcare funding programme, supports a whole spectrum of medical solutions, including preventative care, diagnostics, and treatments. Primarily aimed at supporting SMEs for up to £2 million, it typically has two rounds per year (although recent changes in government have led to uncertainty in future rounds). It explicitly supports funding Phase I and II clinical trials, and projects can last up to 36 months.
Invention for Innovation (i4i) Product Development Awards
Run by National Institute for Health and Care Research (NIHR), focuses on medical devices, in-vitro diagnostic devices and digital health technologies. This opportunity is open year-round and supports collaborative projects of up to 36 months in length, with no maximum funding value.
Tips for a strong application
The biggest challenge when finding grant funding for clinical trials is convincing the assessors that your company is capable of carrying out such a large and complex operation.
You should assemble a strong team, consisting of not only people with technical, scientific and/or medical expertise, but also someone who will design and deliver the clinical study – for example, clinical trial methodologists, statisticians, research nurses, allied health professionals, or social care professionals. People with strong project management experience are also a necessity, and clear recruitment timelines and stop/go criteria for the trial demonstrate good management.
Partnering with an NHS organisation or social care provider to act as the trial site is required by the NIHR, and working with an accredited Clinical Trial Unit (CTU) is expected when running randomised trials. CTUs can help with all stages of the trial, from design to delivery and reporting.
How can FI Group help?
We have experience working on healthcare grant applications, including both those with clinical trials and for Biomedical Catalyst. Our Grants Roadmapping service can review the various projects in your pipeline, from early-stage feasibility studies to technology ready for clinical trials and analyse how they fit into the current and future grant landscape. We will qualify and disqualify projects based on budget, length and scope for different funding opportunities. This means your time is better directed on projects with the highest alignment with grants, leaving you with more time to focus on the research and clinical trials themselves.