All trials have guidelines about who can take part. These are called ‘eligibility criteria’, consisting of inclusion criteria and exclusion criteria. For example, the eligibility criteria for a trial looking at bi-polar disorder might say that the only people who can take part are people who are over 18 but under 80, and who have bi-polar disorder, but no other health problems.
Emergency Medical and Scientific (eSMS)
Emergency Medical and Scientific (eSMS) is a service provided to clinical trial management to increase the level of patient safety for participants. These services include 24/7 adverse event management and reporting, 24/7 emergency unblinding management and reporting, global centralised pharmacovigilance reporting and language and telecoms services.
An epidemiological study looks at how certain exposures (for example, an exposure may be secondary smoke or unprotected sex) or ‘risk factors’ affect health outcomes. An epidemiological study in HIV/AIDS might ask:
How common is HIV in a particular part of the world?
Who has HIV? (For example, do more women than men have HIV? What age are the people who have HIV?
How did they get HIV? (For example, was it through unprotected sex? Or from their mother when she gave birth?)
An evidence base is a collection of the best available scientific research currently available about a healthcare topic, such as how well a treatment or a service works. This evidence is used by health and social care professionals to make decisions about the services that they provide and what care or treatment to offer people who use services.
Exclusion criteria determine who is not able to join a trial – for example, many trials exclude women who are pregnant, or who may become pregnant, to avoid any possible danger to a baby. Trials may also exclude people who are taking a drug that interacts with the treatment being studied. (See also eligibility criteria and inclusion criteria.)