A clinical trial is important because it contributes to the advancement of science. It provides the participants an opportunity to receive potential benefit from a drug, medical device or procedure or even a lifestyle change such as diet or exercise. In a clinical trial, a new medication or product may be compared to one that is currently available. A new medication may be compared to a placebo that has no active ingredients sometimes called a sugar pill. When this new application (medication or product) is studied it may not be known as to whether or not it will help. For that matter whether or not it may be harmful or not make any difference at all.
The investigators that conduct the trials attempt to determine if the medication or product works or is effective. They also attempt to determine if there will be adverse effects associated with the therapeutic intervention. In other words, is it safe for human use? With this knowledge, a determination can be made as to how the use of the product may affect the disease state for which it is being studied.
Clinical trials are designed by investigators who have special interests in particular disease states. The hope is to add medical knowledge relating to the treatment, diagnosis and prevention of diseases.
In general, clinical studies are important because they are designed to add to medical knowledge. Importantly, the results of these trials can make a difference in the care of future patients including possible family members.
If you are interested in participating in a clinical trial, I recommend that you first talk to your healthcare professional. If their resources are limited, use the Internet and go to www.clinicaltrials.gov to start. There are many websites available. If you are eligible to participate in a clinical trial you may be one of the first to benefit from a new treatment. There are many trials ongoing in multiple disease states.
Additional sites include:
- The NIH Clinical Research Trials and You website provides general information on participating in clinical research, with a focus on NIH-funded research.
- MedlinePlus is a Web-based health information service of the National Library of Medicine.
- FDA is responsible for ensuring the safety and effectiveness of drugs, vaccines, and other medical products. Read more about clinical trials and the drug development process on the FDA’s website.
by Theresa Lawrence Ford, MD CEO & Medical Director of North Georgia Rheumatology Group, PC SSF Clinical Trials Consortium (CTC) Committee Chair
SSF Clinical Trials Consortium
The mission of the SSF Clinical Trials Consortium (CTC) is: To increase the availability and accessibility of therapies for treating Sjögren’s by:
1. Supporting and promoting objectives that facilitate the design of clinical trials through the development of:
- Novel diagnostics
- Internationally-accepted classification criteria
- Internationally-accepted outcome measures
2. Increasing industry partnerships with the SSF
3. Engaging in dialogue with government agencies that oversee therapy approval (FDA, EMA) to develop guidelines for new drug/product approval, speed approval of new therapies for Sjögren's and ultimately ensure corporate interest in drug development
As a member of the SSF, you will receive an email or mailing notifying you about any clinical trials in your area that the Foundation is aware of.