If you’ve heard of clinical trials but not sure who is eligible to participate in one, here is some information that might help. A clinical study is research involving human participants that is undertaken to add to medical knowledge and treatments. A clinical trial might also be referred to as an interventional study. Trials can involve drugs or devices but could also involve a change to someone’s diet or a new procedure. Trials involving the testing of new drugs have different stages referred to as phases.
Who can participate?
Each clinical study will have certain criteria called eligibility criteria for those who are needed to participate in the trial. Some trials actively seek individuals with specific conditions or illnesses, while others are looking for healthy adults. Some studies will aim to find a very specific group of people to enrol in the trial.
The criteria that stipulates whether someone can partake or not are called inclusion criteria. Factors which rule someone out of a trial are known as exclusion criteria. These factors could include things like age, gender, stage of condition or disease, existing medical conditions and medical history.
Participants are fully informed about what the trial will involve in a process known as informed consent. Being provided with as much detailed information as possible allows the participant to decide whether or not they wish to proceed. This is aimed at protecting the individual, so they understand all risks involved and of course, any potential benefits. For more information on Clinical Trial Volunteers, visit http://www.trials4us.co.uk/
Other recruitment activities include question sessions, printed material, verbal instructions and interviews to gauge the participant’s understanding for being able to supply informed consent. Even though a participant signs their consent, nothing is binding and that person can still withdraw from the trial at any time.
If you are considering participating in a clinical trial, here are some questions you might want to ask so you can provide your informed consent:
- What exactly is being studied?
- Has it been tested before and why do researchers believe it will be effective?
- What are the various stages of the trial and what can I expect?
- What are the possible side effects or beneficial outcomes I might experience?
- Will I have to be hospitalised or will it involve daily checks at a clinic?
- What tests will I need to undertake?
- Is there any long-term aftercare or requirements after the trial has ended?
- Will I receive any payment for participating in the trial?
- Will I know the results of the trial?