What is a clinical trial?

A clinical trial is a research study that involves human volunteers to test new methods of screening, prevention, diagnosis, or treatment of a disease. Cancer clinical trials often compare the most accepted cancer treatment (standard treatment) with a new treatment that doctors’ hope will be both safe and effective. Clinical trials are carefully designed and monitored to ensure the safety of patient volunteers. Clinical trials are required by the Food and Drug Administration (FDA) before any medication can be used by the general public. Learn more at:  www.nhlbi.nih.gov​

Many treatments used today are the results of past clinical trials.

Who can participate in a clinical trial?

All clinical trials have guidelines about who can participate. Participation in a clinical trial is voluntary. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study. Your study staff and doctor will explain the clinical trial to you. Please take your time to make your decision about taking part. You may discuss your decision with your family, friends and your health care team. If you have any questions, you may ask your health care provider for more explanation about the clinical trial or research study.​

Understand which trials may be right for you. 

Are clinical trials safe?

Participant safety is the number one priority of any study. As a participant, you will participate in process called informed consent. During this process researchers on your health care team provide potential and currently enrolled participants with information about the clinical trial. This information helps people decide whether they want to enroll or continue to participate in the research study.
The informed consent process is intended to protect participants and should provide enough information for a person to understand the risks of, potential benefits of, and alternatives to the study. The informed consent form describes in detail what is involved if you participate in the study. It describes the most common risks for the medication being studied and the potential benefits of participating in the study. You will be able to discuss the informed consent and ask questions prior to signing up for the study. The study staff and doctor will help you fully understand the risks and benefits and your rights as a research participant. Your medical condition will be closely monitored throughout the study by experienced research study staff and doctors.
There are established safety parameters for each study. Participants may withdraw from the study at any time. Groups of experts at the national and local levels approve research studies before they begin. One of the most important groups is called an institutional review board (IRB).The IRB’s job is to review research studies and make sure they are run safely and fairly. All clinical trials should be reviewed by an IRB, which includes doctors, nurses and people from the community. Learn more at: www.fda.gov
The informed consent process is intended to protect participants.

What happens during a clinical trial and why should I participate?

Research doctors, nurses and study coordinators closely monitor the participants throughout the study via physical exams, laboratory tests and other medical procedures. Often, these procedures are described as an extension of what is traditionally done to manage the patient’s health and medical condition. Patients in research studies may receive study-medication, tests and exams at no charge throughout the course of the study.

A patient who participates in clinical research not only receives a treatment that can potentially help them, but also generously helps those who will continue to be diagnosed in the future. It is not known for sure if the new treatment in the study will help you more than the standard treatment for your cancer. Treatments in studies may have side effects. Learn more at: Nih-clinical-research-trials-you

Here are some questions to ask before you agree to participate in a clinical trial:

  • Why is the study being done?
  • How will it help me?
  • What kinds of tests and treatments are part of the study?
  • How am I protected?
  • How could the study change what I do every day?
  • What will happen to my cancer with or without this treatment?
  • What other treatments could I get if I don’t take part in the trial?
  • What are possible short- and long-term side effects for me and my family to think about?
  • How do the risks and side effects of the standard treatment compare with the treatment being studied?
  • How long will the study last?
  • Will my insurance cover my being in this study?
  • Will I have to stay in the hospital during the study? If so, how often and for how long?
  • Will I have extra costs because of the study?
  • How will I be checked after the study?
  • How long do I have to make up my mind about joining this study?

We have patients to thank for the treatments that are available today.​

What are my rights if I participate in a clinical trial?

Any participant who gives consent to participate in a clinical trial or who is asked to give consent on behalf of another has the following rights:

  • To be told the purpose of the clinical trial
  • To be told about all the risks, side effects, or discomforts that might be reasonably expected
  • To be told of any benefits that can be reasonably expected
  • To be told what will happen during the trial and whether any procedures, drugs, or devices are different from those that are used as standard medical treatment
  • To be told about available options and how such options may be better or worse than what is being studied in the clinical trial
  • To be allowed to ask any questions about the trial before giving consent and at any time during the course of the trial
  • To be allowed ample time, without pressure, to decide whether to consent to participate
  • To refuse to participate, for any reason, before and after the trial has started
  • To receive a signed and dated copy of the Informed Consent form
  • To be told of any medical treatments available if complications occure during the trial

Adapted from The Center for Information and Study on Clinical Research Participation. Learn more at: www.ciscrp.org

Participants have rights.​

What are the costs of taking part in a clinical trial?

Research studies have costs, and health insurance does not always pay for all your costs in a study. When you take part in a trial, you may visit the clinic more frequently during a trial than you would under routine care. Your doctor keeps a close eye out for any adverse effects and makes sure you’re safe during the study. It’s important to discuss these expenses with your medical team or social worker. Some health plans will not reimburse such expenses. For more information on clinical trials and insurance coverage, you can visit the National Cancer Institute’s Web site. You can print a copy of the “Clinical Trials and Insurance Coverage” information from this website as well.

There are two types of costs associated with a clinical trial: patient care costs and research costs.

Patient care costs are those costs related to treating your cancer, whether you are in a trial or receiving standard therapy. These costs are often covered by health insurance. They include:

  • Doctor visits
  • Hospital stays
  • Standard cancer treatments
  • Treatments to reduce or eliminate symptoms of cancer of side effects from treatment
  • Lab tests
  • X-rays and other imaging tests

Research costs are those related to taking part in the trial. Often these costs are not covered by health insurance, but they may be covered by the trial’s sponsor. Examples include:

  • The study drug
  • Lab tests performed purely for research purposes
  • Additional x-rays and imaging tests performed solely for the trial

Understand patient care and research costs.​

Will my medical information be kept private?

Efforts will be made to make sure that the personal information in your medical record will be kept private. However, we cannot guarantee total privacy. Your personal information may be given out if required by law. If information from the study is published or presented at scientific meetings, your name and other personal information will not be used.

A record of your progress will be kept in a confidential form at your hospital or doctor’s office where you receive treatment. Organizations may inspect and/or copy your research and medical records (blood samples, x-rays, scans, pathology slides, etc.) for quality assurance, research, and data analysis. If your record is used or given out for government purposes, it will be done under conditions that will protect your privacy to the fullest extent possible consistent with laws relating to public disclosure of information and law-enforcement responsibilities of the agency. These agencies may review the research to see that it is being done safely and correctly. You authorize the use of clinical information contained in your records, but any publication which includes such information or data shall not review your name, show your picture or contain any other personally identifying information, except as otherwise required by law. Learn more at: privacyruleandresearch.nih.gov

Respect the privacy of every research patient.​