How can I take part in a clinical trial?

Discover what it means to take part in a clinical trial and why it’s so important

What is the role of a clinical trial participant?

Potential new treatments must be tested in trials to find out if they are generally safe and effective. But trials can only take place if volunteers agree to participate. Simply put, without volunteers, new drugs could not be developed.

This short video will tell you more about what it’s like to participate in a trial, and the positive impact that volunteers can have on the future health of their family, friends, community, others with the same condition, and people all around the world.

Why we need volunteers

Finding a trial

There are various ways to learn about a trial you may be interested in taking part in:

  • Your doctor may tell you about a trial that they think might be suitable for you
  • You may do your own research. You could start by exploring the Biogen trial finder. There are also online databases, such as clinicaltrials.gov, where you can search for trials relating to your condition that are being conducted across many research sponsors
  • You could ask a patient advocacy group. You may be able to find a support group for other people with your condition online. These groups are highly educated about clinical research and will generally be aware of relevant trials that are currently recruiting, and will be happy to help

What should I do if I’m considering taking part in a trial?

A conversation with your doctor can help you explore if the clinical trial may be a good match for you. After this discussion, either you or your doctor can contact the trial coordinator to learn more.

What should I ask the trial doctor (also known as the principal investigator)?

When meeting with the trial doctor (or another member of the trial team), you may want to consider asking some of the following questions. You could take these questions with you as a guide and take notes as you go along. You may also want to invite a friend or family member to listen in to the conversation for support.

  • What is being studied?
  • If researchers are studying an investigational drug, why do they believe it may be effective?
  • How long will participation last?
  • How often will I have to visit the hospital or clinic? Will any of these visits require an overnight stay?
  • Is there a chance of receiving a placebo?
  • What types of medical tests and procedures will be performed?
  • What are the possible risks and benefits of participation?
  • Will the results of the clinical trial be available to participants?
  • Who will pay for the trial assessments and investigational drug?
  • Will I be reimbursed for other expenses?
  • Is travel support included?
  • Is there a planned extension trial where I can continue to receive the investigational drug and associated health assessments?
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How do I know if I’m eligible to take part in a clinical trial?

A clinical trial is designed for a specific group of people and there are strict guidelines about who can and cannot participate. These are called eligibility criteria.

There are two kinds of eligibility criteria in trials:

Inclusion criteria

Factors that would allow an individual to participate in the trial, such as their age

Exclusion criteria

Factors that would prevent an individual from participating. For example, generally speaking, women who are pregnant, or planning to become pregnant, cannot take part in a trial, in case the investigational drug could have an effect on their unborn baby

Eligibility criteria help researchers identify individuals who can participate in a trial without unnecessary risks.

Don't worry if you’re unsure about whether you’re eligible or not. The trial team will thoroughly check everything they need to know about you against the eligibility criteria before they confirm if you can take part.

And, if they decide you’re eligible, the final decision still rests with you as to whether or not you want to take part.

What are the benefits and risks of taking part in a clinical trial?

If you’re considering whether or not to take part in a trial, it’s a good idea to think about the potential benefits and risks before you decide.

Watch our short video about things to consider before taking part in a trial.

Things to consider before taking part in a trial

Why do people participate in clinical trials?

The best way to learn about why people consider taking part in clinical trials is to ask them directly. The Center for Information and Study on Clinical Research (CISCRP) do just that. In 2019 they conducted a global survey which includes insights from around 3,650 people who have participated in clinical research. Below are some interesting findings.

What motivates people to participate in a clinical trial?

The most common reasons people give are:

  • To help advance science and the treatment of their disease or condition
  • To help others suffering from the same disease or condition

What effect does participation have on people’s daily routine?

Study participation was considered by 44% of respondents to be "not at all disruptive; 37% to be "not very disruptive;" 14% to be "somewhat disruptive;" and 5% to be "very disruptive." People under the age of 44 are more likely to find taking part in clinical trials disruptive to their daily routine than those over 44.

Do people generally participate in the entire trial?

The majority – 75% of respondents – stayed in the study from beginning to end. The main reason people leave early are:

  • Lab test results that disqualify them or other complications
  • Side effects of the study drug
  • Location of study center
  • Communication issue with the center
  • An overly burdensome time commitment

You can read the full CISCRP report here.

We know that deciding whether or not you should join a clinical trial can feel overwhelming at times. That’s why it’s important to reach out to your doctor or the trial team to discuss any potential concerns you may have before making a final decision.

What are the potential risks of participating in a clinical trial?

  • Investigational treatment may cause serious side effects or be uncomfortable
  • The investigational drug may not work, or it may not work better than the standard of care treatment
  • You may receive a placebo
  • The trial could inconvenience you (e.g., time to go to appointments, travel to study site, potential for hospital stay)

Is it safe to take part in a clinical trial?

The safety of the people who take part is the top priority of every clinical trial. There are rules and regulations in place to protect both the health and data of everyone who takes part. And if new information regarding safety becomes available after you have decided to join a trial, the investigator will make you aware of it, so you can decide if you wish to continue to take part.

See also Institutional Review Boards and Ethics Committees.

Protecting your rights

There are internationally recognized ethical and scientific quality standards for the design, conduct, recording and reporting of clinical trials that involve humans. For example, Good Clinical Practice (GCP) ensures that the rights, safety and wellbeing of trial participants are protected, and that the results of the trials are credible and accurate. In addition, the Declaration of Helsinki is a statement of ethical principles developed by the World Medical Association to guide physicians and others involved in medical research in humans.

There are also government regulators, such as the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe. Every trial has to be approved by national and/or regional regulatory authorities before it can begin.

Protecting your data

Health information, personal data, and identifiable information are protected, confidential and secure, and not shared with third parties. Trial data and samples would only be shared for the purposes of further research if you gave your permission. Only the trial team, people hired to perform or manage the trial, will see personally identifiable data. And only trial data that is de-identified will be shared with the company conducting the trial. ‘De-identified’ means that it cannot be linked back to you. Immigration status is generally not collected in clinical trials and will not be collected in any Biogen clinical trial.

What should I expect, before, during and after I take part in a clinical trial?

Throughout the whole clinical trial process, you’ll be empowered to make your own decisions about whether to enroll and whether to stay in the trial. All decisions are made in partnership with the trial team.

Before the trial

You’ll be fully informed as to what to expect through the informed consent process.

During the trial

Your trial team will be on hand to answer any questions you may have throughout the trial and will make sure you know what to expect at each stage. You have the right to leave at any time, without impact on your usual healthcare or any penalty.

After the trial

You’ll be asked to attend a follow-up visit so the trial team can check how you’re feeling and whether you’ve experienced any side effects from the investigational drug.

You may have the option of entering an extension trial, in which everyone who takes part is given the investigational drug. The trial team will let you know if this is a possibility.

You’ll have access to summaries of the trial results, written in a way that’s easy to understand, without any scientific jargon. You can search the results of our past trials using our trial finder, or you can find out more on our clinical trial transparency page.

Where next?

Trial finder

If you’re ready to find a trial that may be right for you, try using our trial finder.

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Medical conditions

Find more information about specific medical conditions that we are researching.

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