Ulcerative colitis and Crohn’s disease are the most common forms of Inflammatory bowel disease (IBD), an umbrella term for a group of intestinal disorders causing inflammation of the digestive tract. Both are long-term conditions, often developing in teenagers or young adults and symptoms can be similar including, but not limited to, diarrhoea, rectal bleeding, stomach cramps and fatigue. Some of the key differences between these conditions are: ulcerative colitis is limited to the large intestine (colon), but Crohn’s can occur anywhere in the digestive tract between the mouth and anus, also Crohn’s can leave healthy parts of the intestine between inflamed areas, whereas ulcerative colitis leaves a continuous line of inflammation in the colon.

All clinical trials must be reviewed and authorised by various governing bodies and committees before they can go ahead to minimise any risks. The Medicines and Healthcare products Regulatory Agency (MHRA) ensures that medicines meet applicable standards of safety, quality and efficacy, meaning a trial must be thought to be safe before it is approved. The Health Research Authority (HRA) is responsible for research ethics committees across the UK. Independent research ethics committees work to protect the interests and rights of volunteers who take part in the trial, adding another layer of protection to the process.

Clinical trials go through a series of phases to test new investigational medicines and assess whether they are safe and effective. These investigational medicines are tested against another treatment, called a control, which is either a placebo (a dummy treatment with no active ingredients) or a standard treatment already in use. Volunteers are randomly assigned to receive either the investigational medicine or the control treatment, these groups are often referred to as cohorts. Researchers monitor the effects of the investigational and control treatments within participants to assess the safety and efficacy of the treatments administered.

Clinical drug trials help doctors to discover new ways to treat a particular illness and are a crucial step in advancing medicine. Volunteers who take part in clinical trials can help to advance medical treatments for a condition, which could benefit themselves as well as other people in the future, however, there is no guarantee that the clinical drug trial will be a success or improve the volunteer’s symptoms. In some cases, the drug trialled may be no better or worse than their current treatment. Clinical trials test the safety and efficacy of new drugs and so involve potential risks, and it is crucial that volunteers fully understand what is involved in the clinical trial before agreeing to take part. Volunteers for clinical trials are always screened to assess their suitability for the trial and will be fully informed of the risks associated with the trial during this screening process.