July 6, 2013

What is a Clinical Trial?

Posted in: Research and Developments

(From “The First Year: Age-Related Macular Degeneration,” (Sep 2006) by Daniel L. Roberts)

A clinical trial involves direct observation of a living patient to answer specific questions about vaccines, therapies, or new methods. It is designed in four phases, during which rigorous protocols must be followed under FDA guidelines:

Phase I: Determination of safety and side effects on 20-80 people

Phase II: Determination of effectiveness and safety on 200-300 people

Phase III: Confirmation of results on 1000-3000 people

Phase IV: Studies done after FDA approval and public use
Testing is accomplished in “trial centers” around the country under approved clinicians, and results are carefully analyzed at each step before permission is given to move on to the next phase.

Clinical trials can take years to complete and cost millions of dollars in time, professional services, product development, and equipment. Sometimes a treatment will not meet the predicted end point, which means that the trial will be stopped, either permanently or until the problem is solved to the satisfaction of the FDA.

You will have to meet certain criteria to be accepted into a trial. Such criteria are announced ahead of time, along with contact information for each testing location. In most trials, you will be randomly assigned to either an experimental group, that receives the actual treatment, or a control group, which receives a sham (fake) treatment. Often the design of the trial is double-masked (also, ironically, called double-blind). This means that neither you nor the researcher knows which group you are in.

Some trials are designed to determine drug dosages and side effects. No control group is used in this type of study. All subjects would receive the treatment, but in differing amounts. These are called dose-ranging, or dose-escalation trials.

You need to understand that participation in a trial does not guarantee improvement of your condition. Sometimes, the hoped-for results are not achieved. Only about one-third of experimental drugs, for example, successfully complete both Phase I and Phase II studies, and only 70-90% of drugs successfully complete Phase III testing. Sometimes you might actually suffer side effects. You will be required to sign a waiver to absolve the researcher of any responsibility for this eventuality.

Clinical trials are announced and described at www.clinicaltrials.gov and www.centerwatch.com. You will also find trials announced in the print and broadcast media, and your doctor should be able to give you information about studies being conducted for your particular condition. You can expect to pay nothing for services directly related to the trial.

By becoming an active participant in a trial, you are helping to blaze the trail toward a cure. With all of the treatments now being tested, it is becoming more difficult to find subjects for trials, so your participation is highly encouraged and valued.

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