The Clinical Research Unit Staff
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• Overview • Industry • Enroll Now
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Clinical Trials
Dr. Maas maintains an active role in evaluating emerging technologies by regularly participating in clinical trials. A clinical trial is the scientific term for a test or study of a drug, therapy, surgical procedure, medical device, or of nutrition or behavioral changes in people. The tests are done to find out if the drug, therapy, procedure, etc. is safe and effective for people to use. Interested individuals may apply to participate as patients in clinical trials. But, before you volunteer to participate in a clinical trial, you might wish to educate yourself on the basics.
Who sponsors clinical trials?
Clinical trials are sponsored or funded by a variety of organizations or individuals. They can be sponsored by doctors, medical institutions, foundations, voluntary groups, pharmaceutical companies, or federal agencies such as the National Institutes of Health, (NIH).
Are clinical trials safe?
Before a prospective treatment is tested on humans, it is thoroughly tested through laboratory and model studies to determine if it's safe.
To ensure patient safety at individual testing sites, strict rules, called "good clinical practices," are set by the federal government (the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP)), which all physicians and other medical professionals must follow. These rules dictate how to properly conduct a study and how to protect human subjects.
There is also an established policy called the "Common Rule" which applies to all research funded by the federal government. The Common Rule says an institutional review board, or IRB, must guarantee it will provide and enforce protection for people involved in its research. An IRB reviews and approves the trial protocol before the trial can even begin. It must look at the informed consent process, benefits and risks, and how volunteers will be selected.
How does a clinical trial proceed? Where would I come in?
After a device or pharmaceutical is tested in the laboratory, it can go to human testing. There are four phases of human testing.
Phase I
Researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate safety, side effects and dosage.
Phase II
The drug or treatment is given to a larger group of people (100-300) to further evaluate safety, effectiveness and to gather additional information regarding safe dose range.
Phase III
The drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments and collect information that will allow the drug or treatment to be used safely.
Phase IV
Phase IV trials may occur after the drug or treatment has been cleared for use by the FDA. During this phase, investigators are looking for additional information, including possible risks, benefits, and optimal use. Trials may also be conducted to evaluate new configurations, new indications and/or effects on different patient populations.
Dr. Maas typically participates in phase III or IV trials.
Why would I want to participate?
The decision to volunteer for a clinical trial is a personal one. Some reasons may include:
- Suffering from the condition that the new product is designed to treat:
• Avoiding the high costs often associated with elective procedures
• Participating in research to further medical science
• Although these are common, there are many reasons an individual may (or may not) decide to volunteer for a study.
How much does it cost?
Most costs in a clinical trial are covered by grants or funds contributed by the trial sponsor. Depending on the trial, you may even receive payment for your participation as a patient. Each trial is different, so it's best to check with the study coordinator to find out the specifics.
Do I have to participate in a clinical trial in order to receive treatment?
No. You may opt for any treatment currently on the market that has gone through all phases of testing and has been cleared for use by the FDA. It is unethical for anyone, including your physician, to pressure you to participate. You should be given complete, accurate and balanced information about the trial. Feel free to take plenty of time to review that information, so you fully understand the benefits and risks before you decide to volunteer.
Even if you decide to volunteer, you may change your mind and discontinue participation at any time for any reason.
How do I know if I am a good candidate?
You may volunteer for any trial appropriate to your condition. However, each clinical trial has strict eligibility requirements. The investigator (physician or other medical professional who runs the trial) will make sure you meet these requirements before accepting you in the trial.
What else should I know?
The study investigator should explain everything about the trial before you make a decision. (That's called informed consent.) However, there are a number of questions you might ask before deciding if a clinical trial is right for you. What is the study trying to evaluate? What "phase" is the trial testing? (See above for an explanation of phases.) What kinds of tests might I have to take? How much time is involved? Will I be hospitalized? What are my other treatment choices? How do they compare with the treatment being studied? What side effects, if any, can I expect? How long will the trial last? Get all the facts so you can make an informed decision.
If you might be interested in participating in clinical trials at the Maas Clinic, please fill out and electronically submit the form under the "enroll" link. Your information will be entered in a secure database for possible eligibility in upcoming clinical trials.
Related Links
Updated CV w/electronic copies of publications linked
FDA Website