What are clinical trials?
- Multi-centre clinical trials
- Newer diagnostic techniques
- Surgical modalities
- Drug trials aimed at new generation drugs
- Fine-tuning of the current treatment protocols
A clinical trial is a type of study that tests a new therapeutic approach in patients to make sure it is safe and effective. Clinical trials have played an important role in the fight against cancer. They are the only scientific way to prove whether a new treatment works better than current treatments. Most of the approaches that doctors use to treat cancer today would never have become available without clinical trials.
Why Consider a Clinical Trial?
Clinical trials may offer patientsâ€™ access to a new experimental treatment before it is available to most patients. Joining a clinical trial is also a way to make a valuable contribution toward the progress against cancer. Many people with cancer are now living longer because of what was learned from past clinical trials. Although every clinical trial is different, most are open to men, women, and/or children of all ethnic, racial, and socioeconomic backgrounds.
How Clinical Trials Work
Who oversees clinical trials?
Clinical trials answer specific questions, such as:
- Is a new treatment safe?
Does the new treatment have a positive effect on patients' disease?
Is the new treatment better than the current standard treatment, or other treatments that might be available?
Which patients benefit the most from a new treatment?
Regional Cancer Center is typically involved in 30-40 clinical trials at a given time, covering a broad range of subjects. Some clinical trials study a drug, a medical device, or a new way of doing surgery. Others test new ways to prevent disease, diagnose cancer, improve quality of life, or help people with cancer manage difficult psychological and social issues. Some clinical trials are small, with just a few patients. Others are large and involve thousands of patients at R.C.C. and other centers around the world.
Who is eligible to participate in a clinical trial?
Every clinical trial has a principal investigator (PI), a doctor who is in charge of all aspects of the study. All institutions that do clinical trials also have an Institutional Review Board (IRB) . An IRB is an independent committee of physicians, researchers, statisticians, community advocates, and others who ensure that a clinical trial is ethical. This makes sure that the risks of the clinical trial are as low as possible, that the potential benefits are greater than any risks, and that any patient who joins the trial is fully protected.
The Institutional Review Board at R.C.C:
- reviews all clinical research studies before activation (enrollment)
ensures that all participants in a clinical trial are informed of what will happen what will happen through the informed consent form
reviews documents related to the progress of clinical trials
monitors every trial from beginning to end, including an annual review to ensure the study is progressing well
How do patients find out what's involved in a clinical trial?
Every clinical trial has guidelines called eligibility criteria that specify who can and cannot participate. Examples of eligibility criteria for a cancer treatment trial include:
- the type of cancer you have
the stage of your cancer (how advanced the cancer is)
what other treatments you are receiving now or have received in the past
In most cases, clinical trials are open to all people who meet the eligibility criteria, regardless of your race, ethnicity, or socioeconomic background.
Clinical trials follow a carefully controlled protocol, a plan of action that describes what researchers will do in the study. The plan is designed to protect patients' health and to answer specific questions.
What are your rights if you participate in a clinical trial?
Before you enroll in a clinical trial, the researchers directing the study must provide you with all of the information in the protocol. They will explain to you the trial's purpose, how long it will take, what will happen, and all potential risks and benefits in a language you understand. This conversation is known as informed consent. Informed consent continues throughout the trial, and is monitored by our Institutional Review Board.
Clinical Trials at Regional Cancer Center
During the informed consent process, you will be informed of your rights. These rights include:
- The decision to take part in a clinical trial is entirely your decision. No one can force you to participate.
You can withdraw from a clinical trial at any time.
If you decide to withdraw, the quality of your medical care at R.C.C. will not be affected.
You will be told about important new findings and about any changes in the study.
Your privacy is protected. Your name and other personal information will not be shared outside of R.C.C. without your written permission, unless the law requires it.
You will be informed of any standard treatment options that are available for your type of cancer. You will also be told about any other clinical trials for which you might be eligible.
The health of every patient who participates in a clinical trial is of the utmost importance at R.C.C. If you choose to participate in a clinical trial, the details of the study will be explained to you completely before you begin. A team of doctors, nurses, and other healthcare professionals will monitor your health closely to determine the safety and effectiveness of the treatment. They will also help you with any side effects you might experience.