Why Participate in a Clinical Trial?
There are many reasons why people choose to join a clinical trial. Some join a trial because the treatments they have tried for their health problem did not work. Others participate because there is no treatment for their health problem. By being part of a clinical trial, participants may find out about new treatments before they are widely available. Some studies are designed for, or include, people who are healthy but want to help find ways to prevent a disease, such as one that may be common in their family.
Many people say participating in a clinical trial is a way to play a more active role in their own health care. Other people say they want to help researchers learn more about certain health problems. Whatever the motivation, when you choose to participate in a clinical trial, you become a partner in scientific discovery. And, your contribution can help future generations lead healthier lives. Major medical breakthroughs could not happen without the generosity of clinical trial participants—young and old.
What is a Clinical Trial?
Clinical trials are research studies designed to improve treatment for patients. Some trials investigate new drugs and treatments while others compare standard treatments against new treatments. Before a new treatment is offered to a patient in a clinical trial, it is carefully studied in the laboratory. All our current standard cancer therapies were once experimental research therapies evaluated in clinical trials. Only after clinical trials show one treatment to be better can that therapy become a new standard treatment. All treatment advances must pass through clinical trial evaluation.
Clinical trials fall into 4 Phases: Phase I – Experimental treatments are evaluated to determine the best dosage and evaluate for side effects. Many treatments do not progress past phase I.
Phase 2* – Once dosage and side effects are known, trials are conducted to get an idea if the new treatment has beneficial effect (a response rate) in a certain disease. More toxicity information is learned.
Phase 3* – The new therapy is compared to the current standard therapy in a randomized trial to see which therapy is better.
Phase 4 – After a therapy or drug is approved and felt to be a standard therapy, many more cases are reviewed in order to detect uncommon side effects or outcomes.
What Happens During a Clinical Trial?
The clinical trial process depends on the kind of trial being conducted. The clinical trial team includes doctors and research staff and other health care professionals who:
- Check the health of the participant at the beginning of the trial
- Give specific instructions for participating in the trial
- Monitor the participant carefully during the trial
- Stay in touch after the trial is completed
Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.
Who Can Participate?
All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results.
Inclusion criteria: The factors that allow someone to participate in a clinical trial
Exclusion criteria: The factors that disallow someone from participating in a clinical trial
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. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial. 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.
Important Participant Questions to Ask
If you are thinking about taking part in a clinical trial, here are some important questions to ask:
- What is the purpose of this study?
- What kinds of tests and treatments are there?
- How does this compare to standard therapy?
- What are my alternative choices for treatment?
- What side effects can I expect? How does this compare to standard therapies?
- How long will the study last?
Am I Free To Drop Out?
Yes, a participant can leave a clinical trial at any time. Taking part in a study is voluntary. You may decide not to enter the study or may leave the study at any time. Leaving the study will not result in any penalty or loss of benefits to which you are entitled. However, if you decide to stop being in the study, we encourage you to talk with your doctor first so that you are informed about any effects that might have on your health. Your doctor will inform you about any new information related to this study. When withdrawing from the trial, the participant should let the research team know, and the reasons for leaving the study.
How to Join a Clinical Trial
If you are interested in participating in a clinical trial, and your physician agrees that a trial would be an option for you, you will meet with one of our coordinators. The coordinator will conduct a brief overview of the study and give you a copy of the Informed Consent and HIPAA, along with their contact information. After you make a decision and want to participate, you will meet with a coordinator and clinical trial assigned physician to sign the HIPPA and Informed Consent. You will be screened for eligibility, and any tests or labs that are needed will be ordered. Once eligibility is established, you will be registered to the study and treatment can begin according to the clinical trial guidelines.