Patients who are considering participation in clinical research trials are encouraged to review the following information:
- What is a clinical trial?
- What are the phases of clinical trials?
- What is a research team?
- What is a protocol?
- What protections are in place for people who participate in clinical trials?
- Will my care be provided in the usual way?
- What is informed consent?
- What are my rights?
- What are the costs?
- What are the risks and benefits?
- Who can participate in a clinical trial?
- What do I need to know if I am thinking about participating?
- Where can I find a clinical trial?
- Where can I learn more about clinical trials?
A clinical trial is a research study conducted with patients to determine whether new interventions are may work. Carefully conducted clinical trials are the safest way to find new treatments that work. Clinical trials can involve the testing of:
- New drugs
- New ways to administer already-approved drugs
- New combinations of drugs
- New treatments in surgery or radiation therapy
- New ways to diagnose and prevent cancer
- Ways to improve quality of life for cancer patients
Phase 1 trials are the first step in testing new drugs in humans. Phase 1 trials are designed to help researchers understand how new medications work and to identify the correct doses and the best ways to give them.
Phase 2 trials help researchers understand how well new treatments work in a particular group of patients and on certain types of cancers. Phase 2 trials also help identify side effects.
Phase 3 trials compare a new treatment or other intervention to the standard treatments that are already used. Phase 3 study patients are typically assigned either to the new intervention (like a new drug or combination) or to the standard treatment.
Phase 4 trials are conducted after a drug or medical device has already been approved by the FDA. These trials test long-term safety or use in larger patients populations.
The research team includes doctors and nurses as well as social workers and other healthcare professionals. A doctor (M.D. or Ph.D.) usually is the clinical trial principal investigator and takes ultimate responsibility for conducting the study. Frequently, a clinical trial will have a research coordinator or study coordinator working on the team. This person may coordinate the day-to-day activities of the clinical trial.
For all clinical trials, the research team will:
- Evaluate a participant’s health at the beginning of the trial
- Give specific instructions for participating in the trial
- Monitor participants carefully during the trial
- Stay in touch with the participants after the study
Participants should learn as much as possible about the clinical trial they are considering. The research team can provide answers to any questions.
All clinical trials are based on a set of rules called a protocol. A protocol defines:
- The types of people who may participate
- The schedule of tests, procedures, medications and dosages
- The length of the study
While in a clinical trial, participants are seen regularly by the research team to monitor their health and to determine the safety and effectiveness of their treatment.
The government and the University of Florida have strict guidelines and safeguards to ensure the well-being of people who choose to participate in clinical trials. Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits.
An IRB is an independent committee of physicians, statisticians, community advocates and others that ensures a clinical trial is ethical and the rights of participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research. Study patients’ rights are protected through:
- Informed consent, which gives a patient all of the important details about the clinical trial before and during participation
- Ongoing monitoring of the trial
- The patient’s ability to change their mind and withdraw from the study at any time
Most of the care provided in a clinical trial is very similar to the standard care provided to most cancer patients. A team of doctors, nurses and other health care professionals will be involved in your care and will monitor your treatment and health status. Research has shown that, in many cases, your care amy be enhanced by participating in a trial.
Informed consent is the full disclosure of important facts about the clinical trial before a decision is made whether or not to participate. The research staff will give potential study participants the details about the study, including:
- Why the research is being done
- What the researchers want to accomplish
- What will be done during the trial and for how long
- What risks are involved in the trial
- What benefits can be expected from the trial
- What other treatments are available
- Informing study participants that they have the right to leave the trial at any time
As a clinical trial participant, you have the right:
- To receive complete information about the study as set forth in the informed consent.
- To decide not to participate or to withdraw at any time without penalty or loss of benefits to which you are entitled.
- To withdraw from the study if new information becomes available about the study that makes you uncomfortable with participating.
- To seek alternative treatment for your condition rather than participate in the study.
- To ask the study staff questions about the study before, during and after your participation begins.
- To have your personal information kept confidential or as detailed in the consent form you sign.
- To receive a copy of the consent form to take home with you for your records.
Many cancer clinical trials include standard tests and procedures for which you or your insurance will pay in the usual way. Some clinical trial costs may be paid by the study sponsor. Before you join a clinical trial, you should review the costs of participation with your doctor or the study coordinator.
Participating in a clinical trial has both risks and potential benefits. Before deciding to take part in a clinical trial, the study doctor and study coordinator will tell you all of the known risks and potential benefits.
Risks: Study treatments may cause side effects and other risks to your health. The amount of risk can depend on your health, the type of treatment and your disease.
Benefits: Participating in a clinical trial gives you access to new treatments that may be better than drugs that are currently on the market. In addition, taking part in cancer research can help other patients in the future.
All participants in clinical trials are volunteers. Some of the reasons that people volunteer to participate in clinical trials:
- To take an active role in their own healthcare
- To gain access to new treatments that are not available to the public
- To obtain expert medical care at leading healthcare facilities during the trial
- To help others by contributing to a broader scope of knowledge
All clinical trials have guidelines about who can participate. Guidelines are based on such factors as age, type of disease, medical history and current medical condition. Before joining a clinical trial, participants must qualify for the study. Some research studies seek volunteers with illnesses or conditions to be studied in the clinical trial, while others need healthy volunteers.
- Participating in Clinical Trials – NIH
- Educational Materials About Clinical Trials – National Cancer Institute