How Clinical Trials Are Funded
Category : General
Clinical trials are an important part of getting medicines or medical devices to market. However, how they are funded remains a bone of contention and funding currently comes from various sources. Here we look at how clinical trials are funded and the processes for getting medical devices and products to market.
Funding of Clinical Trials
Funding for clinical trials comes from the Government, drug companies and charities. Pharmaceutical companies usually fund clinical trials for drugs they are developing while charities who fundraise for research into a specific illness also help to fund clinical trials. The National Institute for Health Research (NIHR) and the Medical Research Council (MRC) conduct Government funded research and trials, while UK patients might also be recruited to take part in research in the USA or Europe.
When clinical trials are being conducted the money needed is to cover administration costs and staff to run the tests and collect the data, as well as analyse the results. This is as well as the cost of treatment and any extra treatment or hospital stays required by the patient. These costs are covered variously by the NHS, Government and drug
Funding Medical Research
The Government announced in September 2016, investment of £816 million over five years to fund health research in the UK. This is good news for patients, however there are concerns that in Europe the processes for getting new medical products to market are not as robust as elsewhere in the world. Things are complicated further following the UK’s decision to leave the EU, as the UK will now have to develop its own processes for doing this.
In the USA, the Food and Drug Administration have a pre-market submission process known as the FDA 510k clearance process. This process is to demonstrate that the product looking to be marketed is substantially equivalent, or at least as effective and safe as an already legally marketed device. The FDA have a Third Party Review Program which allows companies such as T P R G to review submissions and speed up this process.
Here we have tried to shed some light on the funding streams for clinical research. The news that more money is being invested in medical research should be welcomed, as clinical trials are a vital part of this.