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What is a Clinical Trial?
Research Studies and Medical Progress
How do advances in treatment for serious diseases come about? Research Studies – tightly controlled studies of the effectiveness of new treatments – are the engine that drives medical progress. New therapies cannot be approved by the Food and Drug Administration for use by the general public until they undergo rigorous and careful testing in clinical trials. Ultimately, it is through clinical trials that a cure for vasculitic disorders will be found. Patients who participate in clinical trials play an important role in finding a cure.
Patients need to obtain as much information as possible about clinical trials. Patients are told about all known side effects, risks, advantages and research data during “informed consent”. Patients should also be informed about all other treatment options, as well as the outcomes of no treatment at all. Clinical trials are not for everyone.
Advantages to Participating in Clinical Trials
- Clinical trials, involving new drugs and procedures, give you early access to the most promising treatments available for your condition.
- You can receive the best possible care from doctors who are experts in vasculitis diseases at hospitals that are on the leading edge of disease research. You benefit from their individual and collective knowledge and experience in treating many other patients with your condition and related disorders.
- You will be well informed about the possible risks associated with participation in clinical trials. Researchers conducting clinical trials are required to obtain your “informed consent,” meaning that you understand the potential benefits and risks of participating in a clinical trial. The benefits and risks must be clearly explained to you. And you can withdraw from the trial at any time, without compromising your care.
- Clinical research is tightly regulated by federal laws. These laws were created to protect patients and ensure the safety and quality of clinical studies. Each institution conducting research is required to have a specialized office that oversees all research done by doctors who work for that institution. These offices are called Institutional Review Boards (IRB). In addition, the National Institutes of Health (NIH) and Food and Drug Administration (FDA) are responsible for overseeing all research activities that occur in clinical trials.
- Many patients who participate in clinical trials say their experience was a great source of personal satisfaction and provided a sense of contribution to their own care, to the care of others, and toward an eventual cure. Patients also often find participation in trials fun and interesting!
Disadvantages to Participation in a Clinical Trial
- Clinical trials are scientific experiments and often involve some element of unknown risk. This risk is minimized wherever possible. Your willingness to participate in any given study will likely vary based on the nature of the issue under study or your current clinical condition.
- Participation in a clinical trial may take up more of your time than routine care.
Important Points about Participation in Clinical Trials
- Participation in clinical trials is completely voluntary.
- Patients may drop out of a trial at any time.
- Deciding not to participate in a clinical trial does not affect your ability to receive care at any of the VCRC Centers or by other doctors.