Clinical Trials 101

Reject Uncertainty. Help Create the Future.

So what exactly is a clinical trial?

Clinical trials are research studies designed to answer important questions about the safety and efficacy (how well they work) of investigational medications (medicines that have not been approved by health authorities such as the FDA). Without clinical trials, we would not have new medications. In addition, we would know less about diseases and how to treat them.

Clinical trials need to be approved by an Independent Ethics Committee, an organization that is responsible for protecting the rights and safety of individuals who take part in research studies.

What goes into a clinical trial?

Why do we conduct clinical trials?

Clinical trials (also called medical research and research studies), are used to evaluate the potential benefits and risks of a new drug or treatment. Every new treatment must be tested during clinical trials before health agencies (government agencies that approve medications) can approve it for use in the specified disease population.

Answers to some common questions about clinical trials:1

Knowing about clinical trials can help you and your doctor make a decision that’s right for you.

What are the potential advantages and disadvantages of participating in a clinical trial?

Participation in a clinical trial may give you access to expert medical treatment by leading specialists and nurses who are dedicated to finding better ways to treat your condition. Information from clinical trials may help doctors learn more about the disease and its treatment. Also, you could play an active role in managing your disease, and you may also receive access to an investigational medicine at no cost to you. Some trial participants may be allowed to remain on the trial medication even after their participation ends or the trial itself is complete.

However, there is no guarantee that you will receive any benefits from taking part in a clinical trial, and taking part in a clinical trial may or may not cause your health to improve. You may experience side effects. As a participant, you may not be able to choose whether you receive the study, comparator, or placebo medication. Frequent medical visits or testing may be required during the course of the trial.

What should a participant expect during a clinical trial?

If you participate in a clinical trial, you will be working with a medical team, including doctors and nurses, who will be monitoring your health closely. You will have to attend regular visits for a certain time and perform certain tests and procedures. You may need to keep closer track of how you are feeling. This helps the researchers understand how the study medication is working in your body.

How is a participant’s privacy protected in a trial?

If you participate in a clinical trial, a few people, including your doctor and the research team, will need to know some information about you. The research team will not give out information about your participation in a trial without your approval, unless required by law.

During the trial, all information will be kept confidential. While the results of the trial will be published, no individual information (like your name) about participants will be published.

Can participants leave a clinical trial after joining?

Yes. You may decide to stop participating at any time; this will be without penalty or loss of medical benefits. Tell the study doctor if you are thinking about stopping or decide to stop. The study doctor will tell you how to stop safely.

What happens to a participant’s information after one of the studies is over?

Even after the trial is over, each participant’s information is still confidential. Genentech follows the laws of each country where there are research teams, keeping the records of the trials for as long as the law requires. Genentech also follows the Good Clinical Practice international quality standards.

Can a participant continue to receive the study medicine after the initial study?

In some cases, yes. Some trial participants, including those that were given a placebo, may be allowed to start or continue taking the study medication through what’s called an “open-label extension.” This period even includes free study drug for a number of years under continued supervision by the study coordinators.

How does someone get involved in clinical trials for Crohn’s or UC?

You may want to start by talking to your doctor. Download this helpful discussion guide with 10 questions to ask your doctor about participating in a research study.

Learn about the Etro Studies, a series of clinical trials to test an investigational treatment for Crohn’s and Ulcerative Colitis.

 

Reference: 1. www.nih.gov/health/clinicaltrials/basics.htm

 

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