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Hundreds Of Clinical Trials In P.R. Complement Pharmaceutical-Manufacturing Activity
Close to $9 million spent annually to run clinical studies on disease prevention and treatment
By MARIALBA MARTINEZ
August 19, 2004
Thousands of people in Puerto Rico have participated in or are part of 450 clinical trials sponsored by the National Institutes of Health (NIH) to prevent and find treatment for conditions common to Hispanics in the U.S., such as diabetes, coronary heart disease, and hypertension.
As of last week, the NIH-sponsored website www.clinicaltrials.gov listed 160 clinical trials open for recruitment, 146 no longer recruiting or completed, 142 have concluded, and two have not yet begun recruitment.
According to the president of the Ponce School of Medicine, Dr. Manuel Martinez Maldonado, the majority of these trials require as few as one or two participants, given the restricted sources of the sponsoring agency. While some scientists estimate $7 million to $9 million is spent annually on clinical trials in Puerto Rico, the approval of a new law granting a 200% tax exemption on clinical research should attract more funding for such studies sponsored by pharmaceutical companies. With more funding available, additional science & technology jobs should be created.
Doctors who sign up to manage these studies are paid $2,000 to $10,000 per participant or clinical trial, depending on the length of the study and its complexity (frequency of medical exams, size of the target group, and use of medical equipment or technology).
While some look at participants as guinea pigs, without this kind of scientific research, cures for diseases wouldnt be possible. Volunteering for these trials includes experimental drugs or treatments that may include placebos (inactive pills, liquids, or powders with no treatment value). Still, participation in clinical trials remains the safest means to find treatments that improve peoples health.
160 clinical trials recruiting local participants
In Puerto Rico, recruitment is ongoing in 160 clinical trials. Physicians responsible for the studies follow carefully designed protocols (plans that describe who may participate; test schedules, procedures, medications, and dosages; and study length). Inclusion and exclusion criteria used to determine who may participate include age, gender, type and stage of the disease, previous treatment history, and other medical conditions. Some clinical trials use only healthy participants while others require patients with specific illnesses. Clinical trials can take months or years and may include one to tens of thousands of participants.
"The key to administrating a clinical trial is record-keeping," said Lucy Cubano, a former coordinator of the clinical trial "Selenium & Vitamin E in Preventing Prostate Cancer," directed by family medicine practitioner Dr. Jaime Claudios Altamira Family Medicine Clinic since 2001. "While each clinical trial has a different process, there are strict guidelines that must be followed so all data are confidential. Collaboration with the local institutional review board (IRB), a committee of physicians and industry-related members, ensures a clinical trial is ethical, and important periodical reviews of the research are conducted."
Since 1997, Claudios practice has focused on patient and primary-care research of diabetes, cancer prevention, Alzheimers disease, and obesity, in addition to a privately commissioned local study of heavy-metal intoxication. With more than 600 clinical-trial participants, his practice is ranked No. 9 out of 420 study sites in the U.S.
"We are running five clinical trials," said Claudio. "Of these five studies, one is sponsored by the NIH, another is privately funded, and the rest are sponsored by pharmaceutical companies. It is important to keep electronic data and medical records on participants, which can be easily accessed and transferred to our clients. With six full-time employees, our high-band computer connections are linked to the Internet."
Many people dont realize they can participate simultaneously in several clinical trials, depending on the scope of each program. A participant in a clinical trial using vitamins or medicines to measure the absence of illness or disease prevalent in their age or lifestyle bracket can be included in other clinical trials using the same methodology to research the prevention of other illnesses.
Family physician Dr. Miguel Sosa Padilla has ongoing pharmaceutical drug trials in such areas as depression, lipids, diabetes, and coronary heart disease. According to Irma Sotomayor, clinical trials coordinator for Sosa Padilla, pharmaceutical companies generally contact them about testing a new drug. After their research department works out a protocol approved by the IRB, participants are recruited, and data are gathered and periodically sent to the pharmaceutical company.
"In our practice, we monitor both prevention and pharmaceutical-drug clinical trials," said Sotomayor. "Each participant must pass inclusion or exclusion criteria to qualify. Once accepted, they sign a consent form so testing may begin. Follow-ups are scheduled periodically, depending on the trial plan. They are clearly informed that they may leave the clinical trial at any time and that we reserve the right to let them go as well."
Pediatric clinical trials
Pediatric oncologist Dr. Luis A. Clavell is running more than 30 clinical trials in Puerto Rico, mostly sponsored through the CureSearch Childrens Oncology Group (CCOG). In 2002, CCOG spent $28.8 million of $31 million to perform clinical and research trials and laboratory research nationally and to identify the causes of childhood cancer. CureSearch also works with the National Cancer Childhood Foundation and conducts more than 150 clinical trials on the principal cancers affecting infants, children, and adolescents.
"Two-thirds of pediatric cancer patients [in Puerto Rico] have participated in a prospective clinical trial to monitor their condition," said Clavell. "The number recently dropped to 50% after the CCOG underwent a renovation, but we expect to increase clinical trials to 80% of pediatric cancer patients by 2005.
"There are about 120 childrens cancer cases annually on the island (compared to approximately 6,000 adult cancer cases). Only one or two children participate in each pediatric clinical trial although it is common for them to be in more than one trial at a time. Children with cancer are admitted to more clinical trials than adults, who average 5%," Clavell said.
Five kinds of clinical trials are being conducted worldwide. Treatment trials test new treatments, drug combinations, surgery approaches, or radiation therapies. Prevention trials look for better ways to prevent disease in people who have never had the disease, or to prevent a disease from returning, and may include medicines, vitamins, vaccines, minerals, or lifestyle changes. Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition while screening trials test ways to detect certain diseases or health conditions. Lastly, quality-of-life trials (or supportive-care trials) explore ways to improve comfort and quality of life for individuals with a chronic illness.
This Caribbean Business article appears courtesy of Casiano Communications.