Participating in Clinical Trials

Clinical research is medical research that involves people like you. When you volunteer to take part in clinical research, you help physicians and researchers learn more about a disease and improve health care for people in the future. Clinical research includes all research that involves people.

Also known as clinical trials or clinical studies, clinical research checks how well new medical discoveries and therapies work by testing new methods of screening, prevention, diagnosis or treatment of a disease. Fred Hutchinson Cancer Center has more than 800 open clinical trials with approximately half of those being conducted for patients with cancer. 

Clinical trials may help us:

  • Find new ways to prevent cancer
  • Improve ways to detect and diagnose cancer
  • Develop safe and effective treatments for cancer
  • Assess the quality of life of cancer patients and survivors

Common Reasons for Participating

Depending on the clinical trial, participants may be people who have been diagnosed with a specific disease, are survivors of a disease, are at higher risk of a disease or are interested in helping with disease prevention.

Some of the reasons to participate may include:

  • Gaining access to new therapies that are not available to you otherwise
  • Getting additional close monitoring by physicians and nurses, which may help alleviate some of your fears and concerns
  • Helping others who have the same condition by advancing scientific knowledge of the disease and its treatment or prevention
  • Having a chance to learn new ways to improve your overall health and reduce your risk of disease

Participation is Voluntary

People who volunteer for clinical research can choose to leave, or withdraw from, the clinical trial at any time. If you are thinking of participating in or withdrawing from clinical research, discuss this with your clinic care team and the research team. When you are considering participating and throughout your participation, share any concerns, ask questions and tell the care and research teams about any changes in your health. This helps make sure everyone is well informed and working together.

The quality of care you receive at Fred Hutch will not change based on whether or not you participate in a clinical trial or whether you decide to leave a clinical trial you have joined.

We know that decisions about whether or not to participate in a clinical trial can be overwhelming. Fred Hutch research teams and clinic care teams can help you understand clinical trials and make a fully informed decision about participation.

General Risks to Consider

The informed consent form (ICF) will describe all known risks and side effects of the study, to the extent possible, so you can consider them before you decide to join a clinical trial. After you join, the clinical trial care team will share any new information that may affect your decision to stay in the trial. (For example, an intervention may have side effects that researchers did not know about or that happen rarely.) Allergic reactions are always a risk with a medicine that you have not taken before.

What to Expect When Participating in Clinical Research

Below are typical activities for participants in clinical research, in particular therapeutic or interventional clinical trials. Your clinic care team will provide you with the full schedule of activities, including all of the appointments and tasks you will do if you participate.

Initial Screening for Eligibility

Typically, a member of the research team or your care team will connect with you to help identify clinical trials that may be a good fit for you. This usually includes having a prescreening phone call where a research team or care team member talks with you about your medical history, diagnosis and other factors that affect your eligibility. If a clinical trial is identified for you, the research team will give you the full details about the study and answer your questions about participating.

Deciding to Participate and Informed Consent

If you want to learn more about a clinical trial, the research team will schedule an appointment to meet with you, explain the next steps and answer any questions you may have. Before you take part in any other clinical trial activities, the research team will give you the informed consent form (ICF) to review and discuss with your caregivers, family members, friends, clinic care team and anyone else you’d like to consult. You can also contact the research team’s nurse or physician to ask any questions you have about participating.

Participation Review and Enrollment

Usually, if you decide to join a clinical trial, the research team will ask you to fill out forms and surveys that will give them the information they need about your medical history, diagnosis and other information that relates to eligibility. The research team nurse or physician will then read through the ICF with you and answer any questions you have. If you sign the ICF, you will be considered enrolled by the research team to take the next steps.

Participation Appointments

Once you are enrolled in a clinical trial, you will be able to go to your first appointment. For many trials, this is when you start receiving the study intervention (such as medicine) or therapy. During these appointments, the research team will carefully monitor you and check your vital signs. How often you go to appointments will depend on the clinical trial.

Reducing the Risk of Side Effects

To reduce the risk of side effects, there may be restrictions on the medicines you can take while you are participating in the clinical trial and during the follow-up period. The research team will talk with you about all medicines you are taking or want to start taking. 

Monitoring and Follow-Up

When you are participating in a clinical trial, there are typically in-person follow-up appointments that do not involve receiving the therapy. At these appointments, the team will monitor your progress, health and the effects of the therapy to help ensure your safety. It is also common for research teams to monitor and follow up with you over the phone, with virtual meetings and with online surveys.

How to Find a Clinical Trial at Fred Hutch

Fred Hutch care teams can help find clinical trials for you and connect you with the research team for each study. Contact your patient care coordinator to find out more.

You can also search through the list of clinical trials available at Fred Hutch by disease type and other categories.

If you are a Fred Hutch patient, ask your care team about clinical trials that may be available for your type and stage of cancer or disease. They can help you figure out if you are eligible. If you are not a Fred Hutch patient and are interested in participating in a clinical trial, we recommend talking to your current health care provider. Participating in a clinical trial can be a big decision. If you have a caregiver, partner or adult family members you can share your thoughts with, we recommend talking with them and including them in discussions with your care team about clinical trials.

When you are researching clinical trials, check for the following:

  • If the study is in Phase I, Phase II, Phase III or Phase IV. This shows how far along a treatment is in the clinical trial process and which questions the researchers are trying to answer.
  • What the risks of participating are. Make sure the research team is providing this information to volunteers before they decide to participate.
  • The benefits of participating. Check whether the list emphasizes financial incentives, such as free parking or compensation for taking part in the clinical trial, in addition to focusing on the possible medical benefits that can result from participating in the clinical trial. 
  • If you need to provide any personal information. If so, check that the website or research team explains its privacy policy for protecting this information. Be mindful about what information you share and how it might be used.

Get Answers to These Questions

When you are researching clinical trials make sure to get answers to the following questions: 

  • What is the clinical trial name?
  • What is the purpose of this clinical research?
  • What type of clinical research is this?
  • What is the phase of the clinical trial?
  • What tests and therapies does the clinical trial involve?
  • How is the therapy in the clinical trial different from the standard of care for the disease?
  • How long will the clinical trial last, and how long do I have to participate?
  • What is known about the new therapy being researched?
  • How will the clinical trial team know if the therapy is working?
  • What results as well as side effects have been reported so far? Are there any reports showing the effectiveness of the therapy so far?
  • What are the benefits and risks associated with participating?
  • What are the alternatives to participating?
  • Who will monitor my care and safety during the clinical trial?
  • Who can I contact to ask questions during and after the clinical trial?
  • If English is not your preferred language: Will all study information and communications be available in my preferred language? Will interpreters be available in my preferred language for all appointments? If so, how — in person, over the phone or with video conferencing?
  • Will my health insurance pay for therapy I receive in this clinical trial? Are there other costs associated with this clinical trial? Are there other resources besides insurance that can help cover my costs?
  • Do I have to live close to the clinical trial location or can I travel? 
  • What support services are available to me and my caregiver or family if I participate?
  • After reading the informed consent form (ICF), do I understand the clinical trial and the risks and benefits and do I want to participate?
  • How long do I have to consider joining this clinical trial?

Other Resources

American Cancer Society (ACS)

American Cancer Society (ACS) is a national nonprofit organization dedicated to eliminating cancer as a major health problem. In addition to providing information, support and resources for cancer patients and families, ACS is the largest nongovernmental source of funds for cancer research in the United States. 

ClinicalTrials.gov

ClinicalTrials.gov is a registry and results database of clinical trials provided by the U.S. National Institutes of Health (NIH). It includes general information about publicly and privately supported clinical trials from around the world. 

Office for Human Research Protections (OHRP)

The Office for Human Research Protections provides leadership in the protection of the rights, welfare and well-being of people involved in research conducted or supported by the U.S. Department of Health and Human Services. This website may help you understand more about the details that go into safeguarding people who take part in clinical trials. 

National Cancer Institute (NCI)

National Cancer Institute (NCI) is part of NIH and is the U.S. government’s principal agency for cancer research and training. NCI conducts and supports programs in research, training and education in the cause, diagnosis, prevention and treatment of cancer, as well as the ongoing care of people with cancer and their families.

The NCI Cancer Information Service is available free of charge to help answer any cancer-related questions you may have. 

Patients, clinical trial participants, family members, caregivers and friends can take advantage of this service that is available in English and Spanish.

Phone: 1.800.4.CANCER (1.800.422.6237)
Hours: Monday–Friday, 6 a.m.–6 p.m. PT