Clinical Trial

In a clinical trial, no one likes to be given the placebo. Research has shown again and again that many people who participate in clinical trials for new drugs, medical devices or procedures incorrectly assume that the aim of the study is to help the volunteers get better, a fallacy often called the "therapeutic misconception. " Now a new type of study, called an adaptive trial, aims to remedy this problem by increasing the percentage of people who receive a superior treatment during a trial.

Three years after the Food and Drug Administration was taken to task for overlooking safety problems with the diabetes drug Avandia, a panel of FDA advisors met Wednesday to open a two-day review of the research that guided the agency's actions. The meeting's first day brought an exhaustive and often testy dissection of research on Avandia, whose generic name is rosiglitazone. Drawing on an analysis prepared by a team at Duke University Medical School, FDA staff experts said that an early clinical trial turned up no convincing evidence that Avandia raises a patient's risk of heart attack or death.

Three years after the Food and Drug Administration was taken to task for overlooking safety problems with the diabetes drug Avandia, a panel of FDA advisors met Wednesday to open a two-day review of the research that guided the agency's actions. The meeting's first day brought an exhaustive and often testy dissection of research on Avandia, whose generic name is rosiglitazone. Drawing on an analysis prepared by a team at Duke University Medical School, FDA staff experts said that an early clinical trial turned up no convincing evidence that Avandia raises a patient's risk of heart attack or death.

When Maggie Heim had a recurrence of ovarian cancer about a year after her initial treatment, her oncologist suggested that she take what he believed could be a lifesaving drug. There was just one problem: Her insurer wouldn't pay for it. The 59-year-old Hermosa Beach resident inquired about the cost of the treatment at Cedars-Sinai Medical Center, where she received care. To her alarm, she was told that the cancer-fighting drug, Avastin, would set her back as much as $50,000 a month.

The Austrian company AFFiRiS A.G. of Vienna said this week it has begun the first-ever clinical trials of a vaccine to treat Parkinson's disease. The study of as many as 32 patients is designed to test the safety and tolerability of the vaccine, called PD01A. Parkinson's is thought to result from the deposit of pathological forms of a protein called alpha-synuclein in the brain, causing the death of cells, particularly in the region known as the substantia nigra. The accumulation of alpha-synuclein disrupts the production of the neurotransmitter dopamine in the brain, impairing movement and causing tremors.

Make way for the future, at least when it comes to stem-cell therapy. An Atlanta hospital treated the first patient Friday in a nationwide clinical trial of a therapy derived from embryonic stem cells. The clinical trial, run by pharmaceutical company Geron Corp., seeks to test whether experimental cells, known as GRNOPC1, are safe for use in humans and whether patients will regain neuromuscular control in their legs and torsos. The Shepherd Center in Atlanta, a rehabilitation hospital that specializes in people who have spinal cord injuries or disease, and Northwestern Medicine in Chicago are currently enrolling patients in the trial.

Gloria Lucio had two pencil-sized holes drilled into her skull in April, part of a procedure to possibly combat her Alzheimer's disease. The surgeon may have injected an experimental gene therapy drug deep into her brain. Or, after months of tests, consultations and preparation, the Pasadena woman may not have received any treatment at all. The willingness to endure such a surgery for a clinical trial with no guarantee of treatment seems extraordinary. But Lucio and her husband, Don Jones, acknowledge a biting reality: Even if she did get the drug, it may not work.

Hundreds of clinical trials are currently underway at key research centers throughout California, many of which are having trouble recruiting patients. Among the trials that need more volunteers: Smallpox vaccine test: Researchers at Stanford University Medical Center and Kaiser Permanente in Oakland are conducting a clinical trial to test whether diluted doses of the smallpox vaccine produce adequate immunity in adults who have previously been vaccinated.

Nearly 1.3 million fathers, mothers, sisters and friends are diagnosed with cancer each year in the United States. In recognition of this staggering statistic, the federal government has committed unprecedented resources to finding a cure--more researchers, more dollars and more opportunities for a breakthrough. Yet potential new therapies cannot be prescribed until researchers have conducted extensive clinical trials.

Acurian.com http://www.acurian.com Background: Founded in 1998 by health-care executives and a group of venture capitalists who focus on health care, Acurian attempts to find patients and investigators for new clinical trials. Its customers include drug manufacturers and biotech companies.

Last fall, Dena Harris went to a rehab facility to visit her 90-year-old mother, who was recovering from a broken hip. Harris knew something wasn't right: Her mother's skin was pale and her eyes glassy. The doctors diagnosed her with a raging gut infection of Clostridium difficile , a nasty bacterium that causes watery diarrhea. The Centers for Disease Control and Prevention estimates that C. difficile kills 14,000 people each year in the U.S. alone. Harris' mother, Ann Hart, received the standard treatment - a hefty dose of antibiotics - but the drugs provided only temporary relief.

In a clinical trial, no one likes to be given the placebo. Research has shown again and again that many people who participate in clinical trials for new drugs, medical devices or procedures incorrectly assume that the aim of the study is to help the volunteers get better, a fallacy often called the "therapeutic misconception. " Now a new type of study, called an adaptive trial, aims to remedy this problem by increasing the percentage of people who receive a superior treatment during a trial.

The Austrian company AFFiRiS A.G. of Vienna said this week it has begun the first-ever clinical trials of a vaccine to treat Parkinson's disease. The study of as many as 32 patients is designed to test the safety and tolerability of the vaccine, called PD01A. Parkinson's is thought to result from the deposit of pathological forms of a protein called alpha-synuclein in the brain, causing the death of cells, particularly in the region known as the substantia nigra. The accumulation of alpha-synuclein disrupts the production of the neurotransmitter dopamine in the brain, impairing movement and causing tremors.

At any one time, hundreds of clinical trials are underway in the U.S. to test simpler and more effective ways to treat and prevent HIV infection, which afflicts more than 1 million people in this country. Most of those in the U.S. with HIV - and with AIDs in its full-blown stage - are men. So, understandably, men make up the majority of the participants in the trials. However, women, who account for 25% of those living with HIV in the U.S., are significantly underrepresented in clinical trials, according to infectious disease researchers and health professionals who have studied this issue.

In findings that promise radical changes in the care of the 20 million U.S. patients with Type 2 diabetes, two new clinical trials have shown that weight-loss surgery brings about dramatically greater improvement of blood sugar control in obese diabetics than standard diabetes care. In both studies, even rigorously supervised regimens of diet, exercise and medications failed to bring blood sugar under good control after a year or more. In contrast, two teams of researchers - one in Italy, the other in the United States - reported that surgical procedures to reduce the size and sometimes the placement of the stomach often allowed subjects to discontinue diabetes medications within weeks.

Bonnie Addario didn't even know there was a word for what was happening to her. As if lung cancer weren't bad enough, the 54-year-old had lost 30 pounds off her normally 130-pound frame. Her life was limited to her husband's Barcalounger, where she had to recline because she lacked the strength to sit up straight. "It affected everything I did," says Addario, who is alive and well nine years later in San Carlos, Calif. "I literally could not get up and down the stairs. " There is a name for what Addario experienced: cachexia.

Clinical trials are the cornerstone of medical research. Until a new drug or treatment has been tested against existing therapies, physicians are reluctant to use it. But what happens if the patients in the trial cheat? If it occurs often, cheating could call into question the results of many trials. A new report by researchers from UCLA and Johns Hopkins University suggests that the problem may be more serious than previously believed.

Paul Meier influenced the field of statistics in two major ways: as a proponent of a method that helped eliminate bias in determining the effectiveness of treatments in clinical trials, and by introducing a system used to estimate survival rates for patients undergoing different treatments in trials. A longtime professor at the University of Chicago, Meier, 87, died Aug. 7 at his home in New York, said his daughter Joan Meier. He had suffered a major stroke more than 10 years ago and had been beset by a series of strokes more recently, she said.

In a potential breakthrough in cancer research, scientists at the University of Pennsylvania have genetically engineered patients' T cells — a type of white blood cell — to attack cancer cells in advanced cases of a common type of leukemia. Two of the three patients who received doses of the designer T cells in a clinical trial have remained cancer-free for more than a year, the researchers said. Experts not connected with the trial said the feat was important because it suggested that T cells could be tweaked to kill a range of cancers, including ones of the blood, breast and colon.