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CLINICAL TRIALS |
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What happens to the treatment after the clinical trials?
After the first three phases have been completed, the company or researcher studying the treatment submits an application to the Food and Drug Administration (FDA) asking permission to make the experimental treatment available to the public. On average, about 20 percent of treatments successfully make it through all phases of research and are approved. Put another way, for every 100 ideas for new treatments, 20 eventually become standards of care.
On average the approval process takes about a year, but it can take several more. Some drugs are approved in a matter of months. These drugs are considered priority drugs — drugs that provide a significant advance in treatment for a life-threatening condition. The FDA's goal is to rule on these drugs no more than six months after they've been submitted for approval.
Sometimes research continues even after a treatment is approved for wide use. This research, called Phase IV research, tracks what happens to people who use an experimental treatment after the FDA has approved it. In these trials, the investigators record the side effects and results occurring in people who undergo a treatment or take a drug. Phase IV studies usually don't include a control group because the treatment has already been approved.
Phase IV trials aren't required for every treatment that's approved. In some cases, the FDA may require that a manufacturer perform the studies when the agency wants to be sure that there are no other side effects or that the known side effects aren't too serious. Sometimes companies launch Phase IV studies with the hope of collecting data that shows their product is better than a competitor's product.
MORE ON THIS TOPIC
Most medical and scientific journals have in place a process of peer review, in which experts critique the report before it is published, to make sure that the analysis and conclusions are sound. Particularly important results are likely to be featured by the print or electronic media, and widely discussed at scientific meetings and by patient advocacy groups. Once an intervention is proven safe and effective in a clinical trial, it may become the new standard of practice. In this way the development of better interventions for prevention, for treatment, or for detection and diagnosis is an ongoing, continuous process that builds progressively on itself to improve the quality of cancer care and prevention available to us all.
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