We’re here to answer any questions you might have.
A clinical trial, also known as a research study, is a planned test designed to gain results around those tests. During clinical trials, the aim is to learn if a new test or treatment works and is safe. Treatments studied in clinical trials might be new drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments or new therapies relating to general health and wellbeing. The purpose of a clinical trial may be to learn more about:
- New treatments
Clinical trials are sponsored or funded by a variety of organisations involved in the pharmaceutical, medical device, health, and food industry.
All clinical trials have guidelines about who can participate. The main guidelines that allow someone to participate in a clinical trial are called “inclusion criteria” and those that exclude someone from participating are called “exclusion criteria.” These criteria are based on many factors such as age, gender, the type and stage of a disease, previous medical history, current medication use, possibly some test results, and availability to take part. It is important to note that inclusion and exclusion criteria are not used to reject people for any other reason than to ensure all those taking part meet the criteria listed, this ensures appropriate participants are kept safe. Before joining a clinical trial, a participant must qualify for the study. This qualification may be based on you being health or having a specific condition.
Research studies depend on the people who agree to be a part of them. By taking part, you can further medical knowledge and potentially help others. You can also:
- Play an active role in potential new options for your health care
- Get access to new research treatments before they are widely available
- Be seen regularly by a clinical team throughout your participation
- Help others by contributing to medical research
The standards for research physicians and nurses that govern NHS medical practice also apply to clinical trials. In addition, every clinical trial in the United Kingdom must be approved and monitored by a Research Ethics Committee (REC) to make sure the risks are as low as possible and are worth any potential benefits. The REC also ensures that a clinical trial is ethically based on a core set of research rules for practice and the rights of study participants are protected as a priority for all those involved in research. Intelligent Clinical research facility will also be approved by the REC to carry out a clinical trial. All our doctors and nurses must be licenced to practice with either the General Medical Council or the Nursing & Midwifery Council.
Most research studies will provide two forms of payment:
- A fee for travel reimbursement
- A fee for inconvenience around the time involved in taking part
When Intelligent Clinical advertise for any new clinical trial we will provide a summary of what is involved in taking part, how much time taking part might involve, the number of study visits and what travel/inconvenience payment will be available.
This can vary and will be explained before you decide to take part. A routine visit can generally take 1 – 1.5 hours.
We try to schedule study visits around your schedule as much as possible but sometimes this is not always practical when procedures need to be carried out at a set time.
Generally, you will be provided with all the supplies/medication required for the trial at the time of your study visit. If we need to make alternative arrangements, we will still plan on making sure this is delivered to you.
Some studies look at things like your eating, sleeping, activity or general habits, very often this information is kept in a diary. Often this is web based or captured via an app on a phone which the sponsor will provide.
There are always risks when taking treatments—whether they are prescription or over-the-counter medications used routinely in normal care. Side effects can range from mild complications, such as fatigue or constipation, to severe or even life-threatening reactions. As unlikely as they are—only a small minority of us experience adverse effects. The information provided before you decide to take part will outline any potential risks associated with the treatment being researched.
The information provided before you decide to take part will outline contact information, this includes access to the research doctor for any important questions.
The information provided before you decide to take part will outline what access you will have to the results of the trial. Often it can be a long time before the results might be available and each clinical trial can be different in how this is managed. The study team can discuss this further with you.