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Sun January 12, 2014
Health

Clinical trials: How drugs get from R&D to your pharmacy

It takes years for the medication you find in your neighborhood pharmacy to go through research and development. But it takes something more than that for those drugs to make it to your medicine cabinet – clinical trials and people willing to participate in them.

This week on "Take Care," Dr. Lindsay McNair, chief clinical research officer for WIRB-Copernicus Group, a leading independent institutional review board which provides human research protections and ethical research support in the field of drug development, describes how clinical trials work, who participates in them, and why.

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There are three phases of clinical trials.

In phase one, a small number of volunteers participate and the goal is to look at the safety of the drug and to determine the dosage.

A phase two trial involves testing the drug on a larger number of people and the efficacy of the drug is studied. Usually people with the disease or condition the drug is meant to treat participate in this kind of trial.

Phase three of a trial involves the largest number of volunteers and is designed to gather more data on how well the drug works to treat the disease, particularly compared to current therapies if there are any. Dr. McNair says the data from all three phases are combined to help determine whether the drugs should be approved for use in the United States.

Clinical trials vary in length – with phase one being the shortest. The length of time people in the study take the drug depends on how long the treatment needs to last, says Dr. McNair. It could be a single dose in phase one. Later phases range from three months to a year, for drugs that a patient would take for the rest of their life, she says.

But the studies themselves take much longer. First, it can take a long time – sometimes years -- to get people enrolled in a study. And then the participants need to be watched for efficacy and side effects for a period of follow-up.

But who are these people who participate in clinical trials, and essentially assist in getting therapies to patients? Dr. McNair says there are basically three reasons people participate in a trial. Some people just want to contribute and help others. Others with diseases for which there is not an effective therapy, might participate in a trial for a new drug designed to treat their condition.

“They hope that the new drug might give them some relief that their current therapies didn’t,” said Dr. McNair.

A third group of people, particularly in phase one trials, are healthy volunteers who may be paid for taking part in the study.

Some controlled studies involve a group who take a placebo and another group who take the actual medicine. Dr. McNair says there are very strict ethical guidelines for when a placebo is acceptable to be used.

“Those include situations like where there is no available, effective therapy for the (disease). Or for when a delay in treating the condition will not cause a worsening of the condition or increase in symptoms during the time of the delay while that person is taking the placebo,” she said.

Dr. McNair says people do not need to worry they will get a placebo and won’t get treated if they are in clinical trial, they would get the standard treatment for the disease.

Clinical trials are expensive and funded in a variety of ways – by the developer of the drugs, which can be a pharmaceutical company or a hospital or a doctor; through grants from organizations like the National Institutes of Health or the National Cancer Institutes; or by a variety of private organizations, like advocacy groups.

The Food and Drug administration is the agency in the U.S. that approves drugs for human use, looking at all the information from the clinical trials and weighing the risks and side effects versus the benefits.

If you are interested in participating in a clinical trial you can ask your doctor, or research them online. All trials in the U.S. are required to list their study on clinicaltrials.gov. And Dr. McNair says centerwatch.com is another good resource.

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