Clinical trials are usually biomedical or health related research studies in humans that use well organized guidelines. The two main types of studies are as follows:
1. Interventional studies – Studies in which the research participants are assigned by the research investigator to a specific treatment or other approach, and the results or outcomes are measured.
2. Observational studies – Studies in which individuals are observed and their outcomes are measured by the investigators.
Possible benefits of clinical trials are (a) participants often play a more active part in their health care, (b) often gain access to new research treatments before they are widely available, (c) receive expert medical care during the clinical trial, and (c) help others by contributing to medical research.
All clinical trials have guidelines about who can participate, such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. The basis for participation helps ensure that researchers will be able to answer the questions they plan to study.
The clinical trial team includes doctors and nurses as well as social workers and other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed. Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition.
Informed consent is necessary for participation in a clinical trial.
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. If the participant’s native language is not English, translation assistance can be provided. Then the research team provides a written informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the clinical trial at any time.
There are risks to clinical trials.
• There may be unpleasant, serious or even life-threatening side effects to experimental treatment.
• The experimental treatment may not be effective for the participant.
The guidelines may require more of the participant’s time and attention than usual treatment, such as more trips to the study location, more treatments, some hospital stays, or more complex treatments.