"Clinical--Drug Trials"
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Clinical Research Studies Need Volunteers With Alheimer's Disease
The U.S. National Institutes of Health, through its National Library of Medicine, has developed Clinical Trials to provide patients, family members and members of the public current information about clinical research studies. Site Was Set Up To Help People With Desparate Medical Problems To seek Out Last Chance Experiments For Their Particular Condition... Check often for regular updates to ClinicalTrials.Gov clinicaltrials.gov/ct/gui>
Clinical Trails ...Diagnosis and Natural History Study of Patients with Neurological Conditions...The purpose of this study is to improve understanding of neurological conditions. Patients participating in this study will continue receiving medical care, routine laboratory tests, and diagnostics tests (X-rays, CT-scans, and nuclear imaging), from their primary care physician...for specifics visit
Thousands of people, healthy and sick, participate each year in clinical studies. The experience can provide medical, financial and emotional benefits, but there are also potential risks.
Clinical trials are necessary to develop new treatments and medications. The studies typically are conducted at research facilities such as hospitals or at private companies. In the U.S., each trial is approved and monitored by an institutional review board, a group of doctors and others who work to ensure that the clinical trial is run ethically and the rights of the participants are protected.
Participants may receive financial compensation, reimbursements for travel and other expenses, and free treatments and medications.
"People of all health should consider participating," says Christine Grady, Ph.D., head of the Section on Human Subjects Research within the Department of Bioethics at the National Institutes of Health Clinical Center. But she says: "All research has some risk or inconvenience."
Online Listings
People typically find out about the trials from their physicians, but a number of Web sites also track these studies. ClinicalResearch.nih.gov is a patient-oriented site that includes facts and patient stories. It includes a link to ClinicalTrials.gov, a registry of clinical trials world-wide.
Trials are conducted in phases and for different purposes, Dr. Grady says. Researchers in a Phase I trial typically test an experimental drug or treatment in a small group for its safety and potential side effects. Phase II trials expand to a few hundred people, and Phase III, to a few thousand.
At Phase III, researchers also want to compare an approach to other treatments, and placebos may be used. Phase IV trials occur after a drug is approved, to track safety and benefits.
Dr. Grady says that participating in a clinical trial can be a good choice for a patient who has exhausted other treatment options. Also, trials can provide care that is not covered by insurance or even available at other medical facilities.
A Two Time Volunteer
Alwyn Cassil, a spokeswoman for the Center for Studying Health System Change, participated in two studies. In one, she took a medication in a smoking cessation trial but later learned that she had been given the placebo.
She participated in the second trial, which was trying to diagnose cancer earlier, because it included two low dose CAT scans. As a former smoker, she was worried about lung cancer but, without symptoms, her insurance would not cover a scan.
As tempting as participation may sound, there are medical and other risks that individuals should consider. For example, in a drug study, they may be given only a placebo. There may be side effects from a medication or treatment.
"They really need to make sure they're informed about the purpose of the research, the risks and the benefits," says Connie M. Ulrich, a faculty member at the University of Pennsylvania's School of Nursing.
Before enrolling in the study, they also should make sure that their health insurance would cover any medical problems that could occur because of the trial. "They need to understand that this is voluntary," says Dr. Ulrich. "They can withdraw at any time."
Write to Jilian Mincer at jilian.mincer@dowjones.com
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