New medical research findings, such as treatments for diseases, often come about as the result of clinical trials. For people who want to experiment with new research before it is available to the public, or who want to be part of a medical solution to a problem, clinical trials can be a very positive experience.
A clinical trial typically involves health research and follows a set plan of action. In order to produce accurate results, clinical trials are open to people to take part based on a set of inclusion or exclusion criteria. Criteria may range from gender, age demographic and how far advanced a person’s disease has become. Some trials seek participants without diseases or health problems; others seek a group who has a specific condition in which to provide treatments.
Clinical trials can often be placed into one of five major types: preventative toward disease, treatments for medical conditions, screening for detection of diseases, diagnostic, or ways to improve the life quality of patients with chronic diseases.
Processes for clinical trials can vary, but usually involve mental health professionals, social workers and physicians. Participants are monitored at the start of the trial, during, and as a follow-up measure. A team of researchers can also be involved, especially if the trial will involve several medical tests for a disease.
Information participants need to decide if they will get involved is provided through a process of informed consent. Within the informed consent form, the possible risks and the advantages of the clinical trial are outlined and a signature is required from the participant. However, the signature is not fully binding, as a person can stop a clinical trial at any time.
Some risks involved could include health problems or negative side effects of a medical treatment. The treatment may not work and could require a great deal of time, frequent visits to the research location or even hospitalization. The process is carefully monitored, though, from start to finish to help ensure a safe experience. A plan of research, or controlled protocol, is also required. Anonymity of participants is maintained.
If considering taking part in a clinical trial, people are encouraged to understand exactly what the study is intended to do and what premise the researchers have for conducting it. They should ask about the tests that will take place, the risks and consider whether it will have a significant impact on their daily functioning during the trial. Expenses are another consideration, as the patient will want to know if they will be covered for the testing or hospitalization.
In terms of outcomes, participants should know if they will get to learn the study results. Results are usually presented at research meetings or conferences and sometimes made available to agencies within the government. Every study that happens in the U.S. must be preapproved and carefully observed by an Institutional Review Board, which is a committee of doctors, advocates or statistics experts that make sure the study participants are safe and that the research follows ethical procedures.
In the U.S., clinical trials are meticulously monitored and preapproved. For patients who meet the criteria and have evaluated the risks, a clinical trial may be a learning process that provides access to new treatments and allows for a proactive approach to illness.
