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Odds in clinical trials shown to be beneficial for patients

TAMPA — Signing up for a clinical trial is a difficult decision. Many patients fear they will be assigned to receive an older treatment — and not get a shot at the newer, hopefully better drug in final testing stages.

Now an international group of experts can put those fears to rest. Your chances of getting the superior treatment are about 50-50, researchers found, regardless of which drug you receive.

Dr. Benjamin Djulbegovic, an oncologist at the University of South Florida and Moffitt Cancer Center, led the team of researchers that reviewed 743 clinical trials involving 297,744 patients. Their report was published this week by the highly regarded Cochrane Collaboration.

"From the patient point of view, this is good news," Djulbegovic said. "On average, if you are being enrolled in clinical trials, there is a 50 percent chance that you are going to get superior treatment. That superior treatment could very well be the new treatment, or the existing treatment — but that will not be known in advance."

The findings are significant from a scientific standpoint. If newer was always better, Djulbegovic noted, it would be unethical to conduct randomized trials for drugs in final testing stages in which patients are assigned to groups receiving either new or existing therapies. Both sets of outcomes are compared.

"Why would you do a trial if you knew the answer?" he asked. "And ethically, you would be knowingly exposing patients to inferior treatment because you believe you know the answer."

Djulbegovic, USF's associate dean for clinical research, became interested in the topic a decade ago when enrolling a local patient in a clinical trial. The man asked how often the patients receiving the experimental drugs were better off.

"I was taken aback. I didn't know," Djulbegovic said.

To find an answer, Djulbegovic and his team reviewed clinical trials involving new therapies for cancers, neurological disorders and other diseases. They reviewed only publicly funded studies, for which both positive and negative outcomes were available.

Such perspective was necessary because medical journals can be biased in favor of positive results, Djulbegovic said. And pharmaceutical companies don't always release the results of their clinical trials if the new drug wasn't found to be better.

Now doctors and patients can know exactly what they are getting into when enrolling in randomized clinical trials.

"Society can expect that slightly more than half of new experimental treatments will prove to be better," the reviewers concluded. "But few will be substantially better."

Letitia Stein can be reached at lstein@tampabay.com or (727) 893-8330.

Odds in clinical trials shown to be beneficial for patients 10/17/12 [Last modified: Wednesday, October 17, 2012 10:56pm]
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