Every day thousands of people from all walks of life and with varying levels of healthiness around the world safely take part in clinical trials. Clinical trials are set up to establish whether a drug, medical device, therapy or health education programme is an improvement on what is currently available and is safe for patients to use, take or follow.
Regulation
Clinical trials are regulated very strictly from inception to completion. The plan for the clinical trial is known as the protocol, and this has to be given the go-ahead via independent researchers as part of an ethics committee to ensure the robustness or otherwise of the science on which the clinical trial research will be based. Everything from the size of the clinical trial to the patient information sheets will be carefully checked to ensure patient safety is the main consideration of the trial’s originators.
Five Facts About Clinical Trials
By going online, all parties likely to be involved in a clinical trial can find information about what’s involved and a good place to start is https://www.nhs.uk/conditions/clinical-trials/.
1. A trial might take place at a university, a private-sector organisation, a research institute or at an NHS hospital and may be funded by the NHS, a pharmaceutical company, a charity or the Medical Research Council, but whatever the origins of the clinical trial, the results are likely to help improve the medical treatment of countless individuals around the world.
2. A new medicine takes on average 12 years to develop, and without clinical trials, many of the medicines relied on by medical professionals would simply not yet be available.
3. You may come across the term bridging studies, which refers to supplementary studies that are put in place to bridge results from clinical tests from one region to another in order to answer questions about ethnic factors. Organisations specialising in this area of clinical trials include http://www.richmondpharmacology.com/specialist-services/bridging-studies.
4. It has been estimated that it costs more than $2.5 billion to develop and gain approval to market a new drug. The largest single cost in this eye-watering figure? Clinical trials.
5. The UK is recognised as one of the world’s leaders in early clinical trials but is not yet renowned as an innovator in research and development, so the potential to grow this area of the medical world remains to be unlocked.
