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Parkinson’s patient participation needed

Thursday June 30, 2005

CATHERINE SHAROKY

June 24, 2005(ScienceDaily) - "Less than 1 percent of people with Parkinson’s are currently participating in clinical research," said Ben Kirby, communications director of the Parkinson’s Action Network. "That’s just not enough; we need more people to get involved."

The study, conducted by Harris Interactive, found that while physicians have not been referring patients to clinical studies for reasons including lack of information and the status of the individual patient’s disease, nearly 80 percent of patients polled said they would be likely to participate in a trial if it was available in their area.

"What (the survey) found is that in Parkinson’s, there is a dramatic gap between the interest that people have and even doctors seem to have in trials and the actual information that gets transmitted," said Robin Elliott, executive director of the Parkinson’s Disease Foundation. "When too few people participate in trials because they don’t know enough ... then whatever trials there are go more slowly than they otherwise would, and the treatments that we need and the knowledge that we depend on are delayed."

To help bridge the gap between the need for participation and the lack of information available, the Parkinson’s Disease Foundation, the Parkinson’s Alliance Network, the Michael J. Fox Foundation and other Parkinson’s research and support organizations have collaborated to form the Advancing Parkinson’s Therapies campaign to educate people on the importance of clinical studies for the advancement of disease research.

"(Research) is a critical step in developing treatments and ultimately, hopefully finding a cure for Parkinson’s disease," Kirby said. "We’ve been told for a long time now we’re on the cusp of a cure, and we believe that people participating in clinical trials will only advance that and accelerate that."

Parkinson’s is a neurological disorder that affects more than 1 million people in the United States, according to the Worldwide Education and Awareness for Movement Disorders, another group involved in the campaign. Symptoms usually progress from tremors in an arm or leg to total incapacitation, and the risk of developing the chronic disease increases with age. There is no known cure for Parkinson’s, which is why the APT campaign is encouraging participation in clinical studies.

"We’re trying to get the word out as much as possible," said Denise Beran, assistant director of field services for the National Parkinson’s Foundation, which provides support-group information for patients and caregivers. According to disease support groups.

Beran said support groups provide information about clinical-trail options and have begun distributing APT brochures.

"If (patients) want to help advance research, we encourage participation," she said.

One major initiative of the campaign is to provide information on clinical studies through the organization’s Web site, PDtrials.org, which provides information on trial options, current studies being conducted in locations across the country and general information on the disease.

Clinical trials are used to study new medications and treatments for many diseases and are regulated by Institutional Review Boards composed of lawyers, ethicists, physicians and patient advocates who approve trial protocol. Studies can test maximum dosage levels for medications, possible side effects of new medications and comparisons with other known medications.

"There are a number of checks and balances to assure patients that they are being adequately informed and given alternatives, adequately treated, and if side affects appear, adequately taken care of after the trial," said Melissa Goodhead, group director of regulatory affairs and quality assurance for Somerset Pharmaceuticals Inc., a research and drug development company that deals with Parkinson’s.

Patient informed-consent forms, which explain the study and mention risks or possible side effects of participation, must be signed before the study begins, she said.

"It is vital that people tell the absolute truth about trials both in terms of the risks and in terms of the potential benefits," Elliott said.

"Some people think that you go into a trial because you will get a new medication, you will be the first on your block to get it and you will get better before everyone else," he said. "We would not want the people to go into the trial who were betting on getting the treatment and were disappointed when they get the placebo."

Goodhead said many of the patients entering Parkinson’s trials are those who have not responded well to current medications or have been newly diagnosed with the disease and have an opportunity to try new therapies to potentially delay its progression.

"Patients who are doing well in treatment are rarely taken off their medication to be put into a clinical trial," she said.

"Part of the responsibility of a full-awareness process is to make sure that people understand (the risks) and are going in for the right reasons," Elliott said of APT’s efforts in providing information to patients. "The benefits here are primarily the feeling that you’ve contributed to science overall."