About Clinical Research

What is clinical research?

Clinical research is a partnership between healthcare professionals, scientists and patients with the goal of improving medical care, curing diseases and improving the quality of life.  Clinical research studies (also called clinical trials) are the final step in evaluating new drugs, devices or procedures to establish their effectiveness and determine any risks associated with their use. Clinical research can also involve comparing healthy volunteers to individuals with specific conditions to learn more about what causes disease. Before clinical research, doctors chose medical remedies based on their best guess.  Research takes the guesswork out of designing new treatments, and provides doctors with a pathway to find the most effective methods of care.

Research is classified as “clinical” when humans take part in the studies.  But long before a clinical research study is undertaken, the ideas that are tested originate from countless different scientific disciplines, including chemistry, biology and genetics. Ideas undergo initial laboratory testing (called basic research) to determine whether they have the potential to make a difference in medical care. The most promising ideas move forward into clinical studies, which can take place in any number of medical settings, from large academic institutions like the University of Michigan to small community hospitals or clinics.   

Clinical research provides information that is not available from any other source –reliable, measurable results based on the experiences of real-world individuals.  Our government relies upon the results of clinical research to determine whether or not to approve any medical treatment.

There are four different types of clinical research studies:

Clinical research studies are also categorized into four phases, based on the purpose of the study:

Who participates in clinical research?

Research studies are conducted with every population – from infants to the elderly, men and women of all ethnic backgrounds, and both healthy volunteers and those with serious medical conditions. Since medications and other treatments may work differently with different groups of people, it is important that clinical studies measure outcomes for diverse populations, so that the solutions developed will work well for all groups.  Each study has specific guidelines about who can participate, and uses rules to include or exclude individuals in order to produce reliable results.  For example, the guidelines might specify age range, gender, previous medical history, and current medical conditions.  Some studies seek volunteers with specific illnesses, while others require healthy volunteers.

Is clinical research safe?

The safety of participants is the top priority in clinical research studies.  Before a clinical research study is allowed to take place, the design of the study (called the protocol) is thoroughly reviewed by an independent team of doctors, scientific experts in medical ethics and community members called an Institutional Review Board (IRB). They evaluate the safety of the study by reviewing all of the tests and procedures planned, as well as the steps that will be taken to protect the rights and monitor the health and safety of participants. In addition, the federal government regulates most clinical research as well.

What is Informed Consent?

Informed consent refers to the process by which a person learns the facts about a clinical research study before deciding whether or not to participate.  To help you decide whether or not to participate, the healthcare professionals involved in the study explain all of the details, and provide a document that summarizes the study’s purpose, duration, required procedures, and key contacts.  The potential risks and benefits are also detailed.  The Informed Consent document is not a contract – it simply ensures that all of the relevant study information has been explained to you.  Even if you sign an informed consent document, you may still withdraw from a study at any time.

Should I consider participating in a research study?

There are many factors to consider when determining whether or not you should participate in clinical research. 

Some of the benefits to weigh include:

Some of the potential drawbacks to weigh include:

How can I learn more about participating in clinical research?

For information about participating in a clinical research study, visit the following websites: