What is Clinical Research

Clinical research is vital to the development of new medical treatments. Clinical research is the study of medical conditions in people, which enables researchers to gather valuable knowledge to advance medical insights around the world. Without clinical research trials, advances in healthcare and medical treatments would not be possible.

Are clinical trials safe?

FDA works to protect participants in clinical trials and to ensure that people have reliable information before deciding whether to join a clinical trial. The Federal government has regulations and guidelines for clinical research to protect participants from unreasonable risks. Although efforts are made to control the risks to participants, some may be unavoidable because we are still learning more about the medical treatments in the study.

The government requires researchers to give prospective participants complete and accurate information about what will happen during the trial. Before joining a particular study, you will be given an informed consent document that describes your rights as a participant, as well as details about the study, including potential risks. Signing it indicates that you understand that the trial is research and that you may leave at any time. The informed consent is part of the process that makes sure you understand the known risks associated with the study.

What are the different types of clinical research?

Treatment Research:  generally involves an intervention such as medication, psychotherapy, new devices, or new approaches to surgery or radiation therapy.

Prevention Research : looks for better ways to prevent disorders from developing or returning. Different kinds of prevention research may study medicines, vitamins, vaccines, minerals, or lifestyle changes.
Diagnostic Research refers to the practice of looking for better ways to identify a particular disorder or condition.

Screening Research : Aims to find the best ways to detect certain disorders or health conditions.

Quality of Life Research : Explores ways to improve comfort and the quality of life for individuals with a chronic illness.

Genetic studies :  Aim to improve the prediction of disorders by identifying and understanding how genes and illnesses may be related. Research in this area may explore ways in which a person’s genes make him or her more or less likely to develop a disorder. This may lead to development of tailor-made treatments based on a patient’s genetic make-up.

Epidemiological studies : Seek to identify the patterns, causes, and control of disorders in groups of people.

Phases of Clinical Trials

Phase I trials
Researchers test an experimental drug or treatment in a small group of people for the first time. The researchers evaluate the treatment’s safety, determine a safe dosage range, and identify side effects. 

Phase II trials
The experimental drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.

Phase III trials
The experimental study drug or treatment is given to large groups of people. Researchers 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. 

Phase IV trials
Post-marketing studies, which are conducted after a treatment is approved for use by the FDA, provide additional information including the treatment or drug’s risks, benefits, and best use.