About Clinical Trials

Clinical trials are research studies that involve people. Through clinical trials, doctors find new ways to improve treatments and the quality of life for people with certain diseases. Researchers design cancer clinical trials to test new ways to: treat cancer, find and diagnose cancer.

Here’s what typically happens in a clinical trial or study:

1. Research staff explain the trial or study in detail, answer your questions, and gather more information about you.

2. Once you agree to participate, you sign an informed consent form indicating your understanding about what to expect as a participant and the various outcomes that could occur.

3. You are screened to make sure you qualify for the trial or study.

4. If accepted into the trial, you schedule a first visit, which is called the “baseline” visit. The researchers conduct cognitive and/or physical tests during this visit.

5. For some trials testing an intervention, you are assigned by chance (randomly) to a treatment group or a control group . The treatment group will get the intervention being tested, and the control group will not.

6. You follow the trial procedures and report any issues or concerns to researchers.

7. You may visit the research site at regularly scheduled times for new cognitive, physical, or other evaluations and discussions with staff. During these visits, the research team collects data and monitors your safety and well-being.

8. You continue to see your regular physician(s) for usual health care throughout the study.

If you are thinking about taking part in a clinical trial, you may have questions such as:

• Are there risks to taking part in the trial?

• Who is watching out for any problems?

• Who is making sure that people who take part are safe?

• Is the trial trying to answer an important research question?

In fact, there are federal rules in place to help ensure the safety and ethics of clinical trials. You will be protected through:

• The informed consent process

• Careful review and approval of the clinical trial protocol by:

  • Scientific experts

  • An institutional review board (IRB)

• Ongoing monitoring of the trial by:

  • The IRB

  • Data and Safety Monitoring Boards (DSMBs) for phase 3 trials

  • The organization sponsoring the trial

  • The research team

People volunteer for clinical trials and studies for a variety of reasons, including:

• They want to contribute to discovering health information that may help others in the future.

• Participating in research helps them feel like they are playing a more active role in their health.

• The treatments they have tried for their health problem did not work or there is no treatment for their health problem.

Whatever the motivation, when you choose to participate in a clinical trial, you become a partner in scientific discovery. Participating in research can help future generations lead healthier lives. Major medical breakthroughs could not happen without the generosity of clinical trial participants — young and old, healthy, or diagnosed with a disease.

Clinical trials often test how a medical intervention affects people with a certain disease, family history, or lifestyle. Because of this focus, not everyone meets the criteria to participate in every trial. After you consent to participate, the research staff will ask questions and perform tests to see if you are eligible for the trial. The screening may involve blood and other laboratory tests, thinking and memory tests, and a physical examination.

To be eligible to participate, you may need to have certain characteristics, called inclusion criteria. For example, a clinical trial may need participants to have a certain stage of disease, version of a gene, or family history. Some trials require that participants have a study partner who can accompany them to clinic visits.

Participants with certain characteristics may not be allowed to participate in some trials. These characteristics are called exclusion criteria. They include factors such as specific health conditions or medications that could interfere with the treatment being tested.

Many volunteers must be screened to find enough people who are eligible for a trial or study. Generally, you can participate in only one clinical trial at a time, although this is not necessarily the case for observational studies. Different trials have different criteria, so being excluded from one trial does not necessarily mean you will be excluded from another.

Questions about the Trial

• What is the purpose of the trial?

• Why do the researchers believe that the treatment being studied may be better than the one being used now? Why may it not be better?

• How long will I be in the trial?

• What kinds of tests and treatments are involved?

• How will the doctor know if the treatment is working?

• How will I be told about the trial’s results?

• How long do I have to make up my mind about joining this trial?

• Who can I speak with about questions I have during and after the trial?

• Who will be in charge of my care?

• Is there someone I can talk to who has been in the trial?

Questions about Risks and Benefits

• What are the possible side effects or risks of the new treatment?

• What are the possible benefits?

• How do the possible risks and benefits of this trial compare to those of the standard treatment?

Questions about Your Rights

• How will my health information be kept private?

• What happens if I decide to leave the trial?

Questions about Costs

• Which costs do I have to pay if I take part in the trial?

• What costs will my health insurance cover?

• Who pays if I’m injured in the trial?

• Who can help answer questions from my insurance company?

• Who can I talk with about costs and payments?

Questions about Daily Life

• How could the trial affect my daily life?

• How often will I have to come to the hospital or clinic?

• Will I have to stay in the hospital during the clinical trial? If so, how often and for how long?

• How far will I need to travel to take part in the trial?

• Will I have check-ups after the trial?

Questions about Comparing Choices

• What are my other treatment choices, including standard treatments?

• How does the treatment I would receive in this trial compare with the other treatment choices?

• What will happen to my cancer without treatment?