Creaky Trials FAQ

First of all what is an arthritis clinical trial?
A clinical trial is a research study that is used to help develop new treatments for arthritis. Often clinical trials compare new treatments to available treatments or they may study how a certain lifestyle behavior/modification may affect ones health. Clinical trials are required by the Food and Drug Administration before that treatment may become available to the public. A clinical trial can test a drug, a device or a procedure.

Ok, I understand what a clinical trial is, but why should I participate?
Participation in clinical trials is critical to the medical field and to the development of new and better arthritis treatments. When you participate in a clinical trial you are not only helping yourself by gaining access to the newest treatments but you also are helping the entire arthritis community.

So can just anyone "off the street" just join a clinical trial?
The answer is no. When recruiting for clinical trials participants must meet certain criteria that would make them eligible to participate. What you will hear about are inclusion and exclusion requirements. These requirements are needed to provide medically reliable results. For example, inclusion/exclusion criteria can be based on gender, age, weight, stage of disease, etc.

Will I be paid?
Some clinical trials will pay you for joining the trial, while others will not. In some programs, researchers will reimburse you for expenses associated with participating in the research.

What happens in a clinical trial?
Generally speaking the clinical trial team includes doctors and nurses as well as social workers and other health care professionals. They follow a protocol, which is designed to safeguard the health of participants. The clinical trials team checks the health of the participant at the beginning of the trial, gives specific instructions for participating in the trial, monitors the participant carefully during the trial, and stays in touch after the trial is completed.

Clinical trials are federally regulated in order to protect participants. Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure risks are as low as possible and are worth 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 the participants are protected.

What are the benefits and more importantly what are the risks?
Clinical trials both have benefits and risks to participants. It is important that you become aware of them both. The benefits to participating in a clinical trial are:

• Learn more about your health.
• Have health carefully monitored by experts in leading healthcare facilities.
• Feel that you have contributed to new and important research developments.

There are certainly risks that are involved when one participates in a clinical trial. Some risks that you need to be aware of are:

• Side effects from taking the newly tested medicine
• The treatment may not be effective
• The trial maybe time consuming with frequent visits to a clinic or doctorÕs office.

If at any point you wish to leave the trial you may do so freely.

How long does a trial last?
This answer depends on the particular trial. The length of a trial will be determined by that trials particular protocol. Trials are conducted in phases I-IV and help scientists answer different questions.

In Phase I trials researchers test a experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase II trials the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase III trials the experimental study 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 experimental drug or treatment to be used safely.

In Phase IV post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

Will my doctor know about the trial?
When you participate in clinical trials you will continue to work with your primary health care provider. Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care.

Who pays for clinical trials?
Clinical trials are sponsored and funded by a variety of organizations such as pharmaceutical companies, medical institutions, foundations, and other federal agencies.

We like our members to take an active role in their health care. If you decide to investigate clinical trials further, be prepared to meet with researchers and doctors with lots of questions and bring a friend for support. This is an important step in your pain management and it is important that you fully understand what your participation entails. CreakyJoints would like to emphasize the fact that participating in clinical trials is your choice. You need to weigh the benefits and the risks because we are all individuals and what one person perceives to be a valuable benefit may not seem so valuable to you.

Even if you decide not to participate in a trial, researching and understanding the new arthritis developments will help you remain an active and well informed participant in your healthcare.

If you decide to enroll, use our message boards to tell us what it's like. Your reporting is very important. Your experiences will help others decide whether or not to participate.

Article References
Some of this information was obtained from ClinicalTrials.gov.