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Q: Do clinical trials ever go wrong?

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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.

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 Subject :Traveling for Trials .. 2009-09-21 12:57:20 
Sathvika
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altClinical trials are research studies designed to test the effectiveness of experimental treatments or find new ways to use existing treatments.  Currently, more than 77,800 trials are listed on the National Institute of Health’s website.

Clinical Trials
Clinical trials are research studies designed to test the effectiveness of experimental treatments or find new ways to use existing treatments. Prior to human research, most drugs, devices and other therapeutic interventions are tested in laboratories and on animals. All research on humans must be approved by the Food and Drug Administration (FDA). In addition, hospitals have special bodies, called institutional review boards, that oversee the safety of clinical research for patients.

Human trials are divided into four main phases:

Phase I trials aim to find out if a drug or treatment is safe, the best dosage and how it should be given. These trials typically involve only a small number of people (about 20 to 80) and often take place in one or a limited number of locations. During this phase, doctors will closely monitor patients for side effects.

Phase II trials expand upon the results of phase I studies in a larger number of people (about 100 to 300). Doctors continue to test the effectiveness of a treatment while monitoring patients for any side effects.

Phase III trials involve large numbers of participants (1,000 to 3,000 or more) and may take place at several locations across the country. In this phase, the experimental drug or therapy is compared with standard treatment. When phase III studies are completed, the study data can be submitted to the FDA for approval to market the treatment. The FDA can approve the treatment, disapprove or ask for clarification of results or more study.

Phase IV trials are conducted after a therapy has been approved and marketed. These are done to study the long-term safety and effectiveness of the treatment. They are sometimes referred to as post marketing studies.

Participating in a Clinical Trial
There are many reasons people take part in a clinical trial. The trial may provide access to a better or more effective treatment than is currently available. For patients with rare or life-threatening illnesses, the experimental treatment may offer hope for success in fighting the disease or prolonging life. Participants get regular, and often, more thorough medical care and follow-up, enabling doctors to intervene earlier for complications or other potential health problems. Even when a participant doesn’t directly benefit from a clinical trial, the results may help other patients in the future.

While clinical trials may appear to offer promising treatments, participants need to understand the therapies are still experimental, and thus may not necessarily be a better option than standard treatment. In fact, sometimes a treatment or therapy doesn’t have the anticipated effect. And, in some cases, patients may be subjected to unpleasant or serious side effects. Even phase III studies can be risky because sometimes side effects aren’t detected until a treatment has been tested in a large number of people.

Connecting with a Trial
Many clinical trials are run out of larger hospitals and those connected to universities. When patients run out of local options for treatment, finding out-of-town resources can be a frustrating search. Often people turn to the Internet. For clinical trials, a main source of information is the site, http://www.clinicaltrials.gov, a service by the National Institutes of Health. Currently, there are more than 77,800 trials listed on the site. Users can narrow their searches by type of condition, phase of the trial and location. For cancer-specific trials, check out the National Cancer Institute search engine at http://www.cancer.gov/clinicaltrials/search. Many hospitals, universities and research centers also provide a list of trials seeking participants.

People who are considering a clinical trial should gain as much information as possible about the treatment, possible risks and known side effects. Some clinical trials pay participants, while others are offered at minimal or no cost. In other trials, patients are billed for services, and insurance companies may or may not offer reimbursement. So patients who are expected to pay should check with their provider for approval or confirmation of coverage.

In some instances, patients will need to travel a great distance to enroll in an appropriate clinical trial. Sometimes it may mean an extended stay. Participants need to factor in the extra costs of transportation, food and lodging for themselves and accompanying family members when considering an out-of-town clinical trial.


AUDIENCE INQUIRY

A starting point for clinical trial availability and locations can be found at http://www.clinicaltrials.gov
You can search for cancer trials on the National Cancer Institute’s site at http://www.cancer.gov/clinicaltrials/search
Additional information on clinical trials is available from the Food and Drug Administration at: http://www.fda.gov

 

Kristi Runyon   

 

 

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