About Clinical Trials

What is a clinical trial?

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At any given time, there are approximately 25,000* clinical trials underway in the United States for more than 3,000 medical conditions. All of these clinical trials, from AIDS to weight loss, require the participation of patient volunteers for their success. Yet many patients wonder "what is a clinical trial?" and don't understand how important their participation is in order to advance medicine and global health.

Without these patient volunteers there would be no new drugs, therapies or medical devices. Greater Gift’s mission is to recognize the patient volunteers who make medical advancement possible.

Historically, people have entered clinical trials for the primary purpose of contributing to research that will lead to better health for future patients. This is a selfless act. In some cases, especially for people with rare diseases, cancer or those for which there are limited treatment options, like Parkinson’s disease, clinical trials can serve as a treatment option. Clinical trials are also needed for more common medical conditions like migraines, psoriasis, asthma, diabetes…you name it. There is likely to be a clinical trial going on to serve these patient populations.

Clinical trials are also needed for new vaccines, both preventive like the yearly flu shot, and therapeutic like those for a range of conditions like shingles and HPV. This is a complex area of research that requires significant volunteer participation.

Now, more patients are considering clinical trials as a care option when other established treatments have proven to be ineffective or produce intolerable side effects. Greater Gift supports the movement toward Clinical Research as a Care Option (CRAACO). We believe that clinical trials should not be offered as just a last option for treatment and care but be a primary choice alongside traditional care options.

Whatever motivates you to vo­lunteer for a clinical trial, here are a few things you need to know. Remember, too, that clinical trials present potential risks and benefits for the participants.

*Source: clinicaltrials.gov, Phase I-IV Interventional trials

Greater Gift’s mission is to recognize the patient volunteers who make medical advancement possible.

Phases of Clinical Trials

Clinical trials, an integral part of a broader system of clinical research, are generally conducted in four phases. The “sponsor” of the clinical trials, the entity paying for the research, is usually a biopharmaceutical company or a government entity, like the National Institutes of Health.

Phase I involves a small group of people, usually 20-100 “healthy volunteers” who do not have the disease or condition being studied. The purpose of these trials, often conducted in a clinic setting over a period of weeks or months, is to determine whether a drug is safe for further testing in humans. An exception to these conditions is new cancer drugs in development where, because of their potency, are almost always first tested on patients with the cancer being studied.

If a Phase I trial has been successful, the sponsor may decide to move on to Phase II where a larger group of people, perhaps several hundred, with the condition being studied are given the experimental treatment. At this stage, the object of the study is to prove that the drug shows signs of effectiveness as well as being safe. Phase II trials may take up to two years to complete.

If Phase II results are promising, the research will move on to Phase III. Here, hundreds or perhaps thousands, of patient volunteers will be needed and the study could go on for a period of years as the goal is to gather enough evidence to seek approval from the Food and Drug Administration to market the drug.

After a drug is approved, there may be Phase IV trials that look for potential other uses for the drug or to continually monitor its safety, effectiveness and side effects.

Note: This is intended to be a general, non-technical explanation of clinical trials for those considering participation. Before enrolling in a clinical trial, we suggest you consult your with your family and physician and review additional information from the NIH or CISCRP.

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