Clinical trials, whether for mesothelioma or other illnesses, are conducted in a series of four phases, each designed to answer a separate research question.
Mesothelioma clinical trials collect data regarding the safety and efficacy of new drug, device or procedure development – all with the aim of improving methods of diagnosing, preventing and treating mesothelioma. Before a drug or device can be offered on the consumer market, it must pass through three phases of a clinical trial before it reaches phase IV, where it can be approved for use by the general public.
Researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
The experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
The experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
In Phase IV trials, post marketing studies delineate additional information including the drug’s risks, benefits, and optimal use.