Clinical Research 101

This video explains the different types of clinical research studies, observational and interventional, and goes in-depth about the different phases of clinical trials and the process of informed consent.

Read the full video transcript below:

This video is an overview of clinical research for patients considering participating in a clinical research study.

Clinical research is the study of the most promising advances in the medical field.  

When patients volunteer to join clinical research, they are called participants.

There are two types of clinical research studies – observational and interventional.

Observational studies are used to find patterns in biological samples like blood or tissue. Some observational studies include imaging, like MRIs or CAT scans. Participants do not receive a new treatment. They simply allow researchers to study blood or fluid samples to look for possible opportunities to improve care.

Interventional studies or clinical trials, show us whether new medicines, tests or medical devices are safe and effective.  Clinical trials are the safest way for doctors to study how we can improve treatments for diseases.

Trials are performed in phases to maximize patient safety.  New treatments can be tested in Phases 0-4.  But the most common clinical trials are phases 1-3.  

Phase 0 Trials are not always necessary.  When done, phase 0 is the “first in human” use of a new drug or treatment.  They will check if and how a drug may work by using small doses on a small group of people. 

Phase I Trials are usually the “first in human” clinical trial.  These trials explore how much of the drug can be given safely.  Doctors monitor participants to see if they have had side effects.

Phase II Trials look into whether the drug works on certain diseases. If the drug improves a medical problem, it has efficacy.  Sometimes phase II trials compare groups of participants receiving the drug with participants who aren’t receiving any treatment, also called a placebo group.

Phase III Trials test if the drug is working better than the current standard treatment. These trials measure BOTH safety and effectiveness of the new treatment against the current standard of care.

Phase IV Trials study a drug that has already been approved and is currently available on the market. These studies look at the safety of the drug over time.  Researchers are studying if there are any rare side effects.

Before taking part in a trial, participants must provide informed consent. Informed consent is a process where research teams provide all the information patients need to decide if they want to to participate in a trial.  Once they agree, patients sign a document and become a participant.

Even after signing consent, participants have the right to leave the study at any time without risking losing care that they would receive outside of the trial. This is called revoking consent, or withdrawing from a trial.

Joining a trial has risks and benefits. Risks are unique to each trial, and patients considering signing up for a trial should discuss with their doctor and loved ones before signing informed consent.  The main benefit to enrolling in a trial is to patients in the future. They may receive more customized treatment based on the results of clinical trials performed in the past. 

For more information, talk to your doctor or caregiver.