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Clinical trials are research studies intended to answer scientific questions to help understand whether an investigational treatment is both safe and effective for people with a particular disease or condition.

When it comes to learning more about diseases and ways to keep people healthy, clinical trials are essential. In fact, without them, modern medicine would not exist!

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Why they’re important

Because of participation from people like you, clinical trials help:

Why they’re important

Develop potential new medicines.

Finding a trial

Discover if certain medicines work better than others.

Why they’re important

Find new uses for already-approved medicines.

Clinical trials—nothing new!

The first documented clinical trial dates back to 605 BC, when King Nebuchadnezzar II of Babylon tested a meat vs vegetable diet on his people. Spoiler alert! People eating veggies fared better.1

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I’m interested in a trial! What’s next?

Finding a trial

Finding a trial

There are many online resources, such as this website, to help you find a study that could suit you. You can also ask your doctor about trials for your condition.

Study entry criteria

Study entry criteria

Every study has specific criteria for who can take part. The study team will assess your health and check that you would be a good fit.

Informed consent

Informed consent

All clinical trials are voluntary. The study team will discuss all the known risks and benefits with you, and you will sign a form to confirm you understand. If you have any new or additional questions along the way, please don’t hesitate to ask.

Study visits

Study visits

For most studies, you will visit a study clinic or doctor’s office. How often will depend on the type of study and requirements. At each visit, your study team will check in with you and may conduct certain tests. Visits may also be on the phone or at home.

Follow up

Follow up

To keep a close eye on your health, there may be a follow-up period after the trial where the study team keeps in contact with you.

 

It’s also important to note that if at any time you wish to leave the study, that’s OK! Just let your study team know so they can do a final check on your health.

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Types of trials

Developing a new treatment can take a long time, sometimes even more than a decade. This is to ensure the treatment has been properly tested and is effective and safe enough for you and the greater public.

When a potential new drug or treatment is being tested, the process is broken down into small steps called phases. Usually, a new phase can’t start unless the previous one ends. In some cases, a drug may actually skip a phase. Additionally, trials may combine phases. But, typically, phases look like this:

Phase one

Phase 1 trial

The initial study of an investigational drug in a small group of participants (about 20-80 people) to learn about its safety.

Phase two

Phase 2 trial

Continues to evaluate safety by testing the drug on a bigger group of participants (about 100-300 people).

Phase Three

Phase 3 trial

Looks to confirm the safety and effectiveness in a greater group of participants (about 1000-3000 people), often in comparison to existing treatment. 

Approval phase

Approval

If the studies prove the drug is safe and effective, it may be approved for use in appropriate patients.

Phase four

Phase 4 trial

After a drug is licensed and approved by the FDA researchers track its safety, seeking more information about its risks, benefits, and optimal use. 

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A common myth: All trials test drugs

Actually, many clinical trials collect data and samples, observe behaviors, or test other treatments not created in a lab.

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  1. Collier R. Legumes, lemons and streptomycin: a short history of the clinical trial. CMAJ. 2009;180(1):23-24.
    doi: https://doi.org/10.1503/cmaj.081879  

This website contains images of actual patients who were compensated for their time.

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