What is a Clinical Study?

Principal investigator reviewing data from clinical studyClinical study is a term that is often used interchangeably with clinical trial. During a research study, clinical investigators gather data on volunteers (also known as participants) that’s intended to help improve available medicines and knowledge of a given medical condition.

Clinical studies are medical and scientific studies that test new drugs and medical treatments. Government agencies, private organizations or pharmaceutical companies usually sponsor clinical studies (also known as clinical trials or interventional studies). Before a drug reaches the clinical studies phase it has been researched extensively and it has been determined that the drug has potential as a new and better treatment than what is currently available.

The Four Phases of Interventional Studies

Clinical research in humans generally involve four phases, phase I – phase IV. At each phase the number of participants increases. Studies can take place at one facility or at many facilities across the country, or even around the world. The drugs are tested first for safety, efficacy and proper dosing amounts.

Clinical studies have a specific protocol that is developed and followed by everyone who participates. A clinical team made up of doctors, nurses, lab technicians, and other medical personnel runs the studies. Before the study begins potential participants are screened based on certain criteria. They are often given medical screening that tests their blood, urine and heart health.

How is an Observational Study?

Similar to an interventional study or clinical trial, a research team follows a specific protocol to test the health outcomes within a group of volunteers. The participants may also be administered specific medications or procedures during the study period, but clinical investigators do not assign them to a specific intervention like they would in a clinical trial– it is purely observational.

Who Oversees a Clinical Research Study?

There is a principal investigator that is assigned to lead each approved clinical study. These investigators are usually experienced medical doctors, and they will be managing a full research team that can include:

  • Doctors
  • Nurses
  • Lab technicians
  • Social workers
  • Health care professionals

As mentioned earlier, clinical studies are often sponsored (funded) by pharmaceutical companies or federal agencies like National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC). However, they may also be sponsored by:

  • Academic medical facilities
  • Non-profit organizations
  • Physicians and other individual health care providers

Who Can Participate in a Clinical Study?

How the clinical research study is conducted depends entirely on the plan laid out in the protocol. This has been meticulously laid out in order to help ensure the safety of research volunteers and answer several questions for the research team.

The eligibility criteria is also laid out in the study protocol which essentially details who can participate in a given study. Some may only be enrolling people who have been diagnosed with a specific illness, while others are looking for healthy participants. Others still may be limited to a group that has been pre-selected by the principal investigator and their research team.

Volunteers may wish to participate in clinical trials for several reasons. Some have diseases that have not successfully been treated by traditional treatments. Others are seeking access to experts and new treatments. All participants are asked to give informed consent, meaning they are told all of the details of the clinical study before they agree to participate.

Clinical studies are regulated by government agencies that review and approve studies before they begin. The safety of participants is of utmost importance throughout the process. Thanks to volunteers, clinical studies help advance the knowledge and effectiveness of new drugs and medical treatments for everyone.