Clinical studies refer to research involving human volunteers (also known as participants) to contribute to medical knowledge. With this in mind, it is important to also note that there are various kinds of clinical studies as well.
Types Of Clinical Studies
In observational studies, investigators observe individuals in a normal setting. Researchers investigate the health outcome in a group of volunteers according to research protocol and plan. The group volunteers based on broad characteristics, gather information and observe changes over time.
For instance, investigators might collect data via medical tests, exams, or questionnaires about a group of older adults over time to know more about the effects of various lifestyles on cognitive health. These studies assist in identifying new possibilities for clinical trials.
These are research studies carried out on participants; they focus on evaluating a surgical, medical, or behavioral intervention. Clinical trials are the primary way that researchers use to understand if a new treatment such as a new diet, drug, or medical device like a pacemaker is effective and safe for human beings.
Normally, a clinical trial is used to know whether a new treatment has minimal harmful side effects and is more effective than the standard treatment. The investigator tries to evaluate the efficacy and safety of the intervention by weighing specific outcomes in the volunteers.
For instance, the investigator may offer treatment or drugs to participants with high blood pressure to check whether the blood pressure lowers. Some clinical trials examine ways of finding diseases early, even before symptoms appear. While others test to hinder a health problem before it occurs.
Clinical trials might also concentrate on how to make better for individuals suffering from life-threatening illnesses or chronic health issues. Sometimes it looks into the roles of support groups and caregivers.
Clinical trials applied to MDMA and drug development are described by phases in some instances. The Food and Drug Administration dictates the phases.
Some individuals who aren’t eligible to participate in a clinical trial might be able to acquire experimental devices and drugs outside of a clinical trial via expanded access.
Who Conducts Clinical Studies?
Each clinical study is headed by a clinical investigator, usually a medical doctor. Clinical studies also comprise a research team that includes nurses, doctors, social workers, and various healthcare professionals.
Clinical studies can be funded or sponsored by academic medical centers, pharmaceutical companies, voluntary groups, various organizations, and federal agencies, including the National Institute of Health and the Department of Veteran Affairs in the U.S.
However, health care providers, doctors, and other individuals can finance clinical research.
Where Are Clinical Studies Conducted?
Clinical studies usually take place in various locations such as universities, community clinics, hospitals, and doctors’ offices. The location varies depending on who is carrying out the study.
Who Can Participate in Clinical Study?
There are standards outlining who can participate in a clinical study. These guidelines are known as eligibility criteria and are included in the protocol. Some clinical studies look for volunteers with conditions or illnesses to be studied. In contrast, others look for healthy participants, and some only involve a predetermined group of individual investigators’ requests to enroll.
Factors that disqualify an individual from participating in a clinical study are exclusion criteria, while those that allow a person to participate are known as inclusion criteria.
These factors are based on gender, age, treatment history, age of diseases, and various medical conditions.