Understanding Clinical Trials

Myth: The selection process is unfair

Some people who try to volunteer for a clinical trial are told by the research team that they are not allowed to be in the trial. The process seems unfair.

All clinical trials have guidelines about who can participate. Before joining a clinical trial, a participant must qualify for the study. Using inclusion and exclusion criteria is an important principle of medical research that helps to produce reliable results.

Patient perspectives

Alicia, a research professional learns firsthand what matters most to patients:

“Patients want to be treated, as a patient you really don’t care that someone didn’t dot an ‘i’. You care that they sat and listened and cared. Patients don’t care about the paperwork. They don’t care about database locks. They care about the interaction.”

Selection process

The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria". These criteria are based on such factors as:

• Age
• Gender
• The type and stage of a disease
• Previous treatment history
• Other medical conditions

It is important to note that inclusion and exclusion criteria are not used to reject people personally. These rules are to protect volunteers and to help researchers understand if the effects they see are caused by the trial medicine.

Some medicines may work more effectively in specific subgroups of people, for example people with a more advanced stage disease or with a specific gene mutation. If you do not meet these criteria, the medication may not work as well for you, thus skewing the trial results but also not helping you with your condition.

Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. The rules are different for each trial, and are always listed in the informed consent document.