Clinical studies (or trials) are done to answer a specific research or medical question.
Study participants receive specific interventions according to a research plan or protocol. Interventions may be medical products, such as drugs or devices or procedures. Clinical studies are essential to test whether an interbention is safe and effective before approval can be granted for use in the wider population.
Clinical studies are one of the later steps in a long process of drug development which involve extensive pre-clinical research. Only interventions that are evaluated as reasonably safe and show the most promise, progress to clinical studies in people. They are required by regulatory agencies such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) before a new treatment can be brought to the market. Regulatory agencies are committed to protecting participants in clinical studies and to providing reliable information to the public.
Participating in a clinical study is voluntary and there are many factors that need to be considered before making a decision that is right for you and your family. Issues such as time away from home, travel requirements to appointments, and the medical procedures required during the study, need to be considered. Ultimately it is a personal choice that you and your healthcare team should make together. Deciding not to participate in a clinical study will not affect the care you receive.
To volunteer for a clinical study you must meet the eligibility criteria. These are the rules for who can be recruited into a study, and include inclusion and exclusion criteria which are specific for each study. These could include: age, sex, specific genetic mutation, stage of disease, previous treatment history, and presence of other medical conditions. The eligibility criteria aim to give the study the best possible chance of success, help protect participants and ensure that it is safe for them to participate.
Before enrolling each participant will undertake a complex and rigorous screening process. There is no guarantee that a participant will be enrolled until the screening data has been evaluated. Prior to enrolling the study doctor will discuss elements of the trial such as: the length of the study, the number and interval of visits required, study related physical exam or outcome measures will be described and other tests or questionnaires required during the study. The study consent will be described discussed prior to enrolment.
Costs and resigning
A screening visit is scheduled to discuss and answer any questions prior to signing the study consent and to complete all questionnaires, examinations and lab work associated with the screening process. It is important to note that participation is totally voluntary and that you may, at any time, resign from the study without penalty and without compromising the right to receive standard treatment. The cost of all the tests and examinations associated with clinical studies are covered and there are no trial-related fees.