Inclusion Criteria

Inclusion criteria are the characteristics that potential participants must have in order to be considered for participation in a trial. They describe the patient population and patient selection criteria.

Inclusion criteria should specify the type of testing used to make the patients’ diagnosis, as well as specific disease requirements (for example, how severe the disease is, failure or success with previous treatments, plus any other factors that might affect prognosis such as age, sex, or ethnicity).

The inclusion criteria (and exclusion criteria) are important parts of a trial protocol. If they are properly defined, inclusion and exclusion criteria will increase the chances that the trial produces reliable results. They also protect participants from harm and minimise the risks.

Glossary: Eligibility
Glossary: Exclusion Criteria
Making a medicine. Step 8: Confirmatory studies
Phase III clinical studies, or confirmatory studies, are the final confirmation of the safety and efficacy of a medicine before it can be launched on the market. Phase III studies are the largest, most complicated, and most expensive part of the medicines development process, and nearly 50% of medicines that enter this phase will fail.
Enrolling in clinical trials
The process of enrolling in clinical trials is carefully regulated, as is the way in which sponsors advertise clinical trials to prospective participants. Patients are screened and must give their informed consent before they can enrol in a trial.
Phase II Trials
In Phase II trials, the investigational medicinal product is tested for efficacy (and safety). The studies conducted are typically therapeutic exploratory studies which try to discover whether the medicine treats the intended disease or condition.

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