The Joys of Clinical Research
by Nathan Wei, MD, FACP, FACR
Nathan Wei is a nationally known board-certified rheumatologist and author of the Second Opinion Arthritis Treatment Kit. It's available exclusively at this website... not available in stores.
Click here: Second Opinion Arthritis Treatment Kit
Each year thousands of patients volunteer for clinical trials involving new arthritis medicines.
Reasons given for participating include:
• Wanting to advance medicine to help future generations
• Hoping to benefit from cutting edge technology
• Obtaining free medical care
• Being paid to volunteer
Here are a few things you need to know before you consider volunteering for a research study.
Research is done in both university settings as well as in private offices. Most research is funded through pharmaceutical and biotechnology companies with a substantial number of grants also coming from the National Institutes of Health and private donations.
All of the drugs currently available for the treatment of arthritis went through the clinical research process.
An overwhelming majority of patients (77%) say they would want to participate if the opportunity presented itself. Many patients aren’t offered the opportunity to participate.
While most people recognize the value of clinical research in the advancement of medicine, a much smaller percentage knows very much about the research process.
Once a drug has shown promise in the laboratory and in animals, it is ready for human testing. Only one in 10,000 compounds discovered in the lab actually makes it to human clinical trials and eventual approval. The average time from discovery of the compound to FDA approval is 10-15 years. The cost to develop a new medicine is approximately 1.5 billion dollars.
Clinical research studies are divided into four phases:
Phase 1 studies study the drug effect in normal volunteers. The emphasis is on safety.
Phase 2 studies study the medicine in patients who have the disease being studied. The emphasis is on safety but now the drug is being evaluated also for efficacy.
Phase 3 studies are the large multi-center placebo controlled studies where the drug is studied for safety and efficacy in large numbers of patients. If the drug look promising, it is submitted to the FDA for approval.
Phase 4 studies are done to look for possible beneficial effects in subsets of the disease or in other diseases states.
One question is “Why does there have to be a placebo? The answer is simple...
To negate the expectation factor.
When a patient takes a medicine they expect to get better. If a physician gives a patient a medicine, they expect the patient to get better. If the physician gives the patient a placebo, they, consciously or unconsciously, transmit the idea, “I don’t think this will work.”
So it’s important that both the investigator as well as the patient be blinded to what the patient is receiving. Still wonder about this? Well... the placebo response in arthritis clinical trials can be as high as 40 per cent!
The most important priority in clinical research is patient safety. That’s why the patient is watched so carefully. Also, it is imperative that informed consent, a process where the patient is told all the risks and benefits of participating, be presented. The informed consent document must be read and reviewed carefully.
Every study must pass the scrutiny of an Institutional Review Board or IRB. This is a an organization that monitors a clinical trial for quality assurance and ethics.
The patient has the right to leave the study at any time.
What should you look for in a research center? Here are a few important items:
• Experience: the investigator should have at least twenty years of experience in research
• Reputation: the center and the investigator should have an excellent reputation
• Staff: the staff must be well trained
• Publications: expect at least fifty publications in peer reviewed journals
• Accessibility: will the research staff answer your questions?
Participating in clinical research is not without risk. Adverse events (AE’s) related to study medication can occur. However, the risk of serious injury or side–effects is low. Much lower than risk from traffic accidents, for instance.
Benefits include the excellent medical care a patient will receive. While this is not a substitute for having a primary care physician, research patients are watched very carefully.
After a study is completed, a patient may, is some instances, be allowed to continued the study medication. This is a huge benefit because many of these medicines are extremely expensive.
Finally, some studies will pay patients a stipend to participate.
Most patients who participate in clinical trials will want to do it again. Thee experience is interesting and rewarding.
The future for arthritis research looks very bright. Currently, a number of clinical trials involving new drugs for both RA as well as OA are in the pipeline.
Get more information about clinical research as well as...
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• And much more...
Click here Second Opinion Arthritis Treatment Kit
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