SIXTY MONTHS. Sixty reviewed studies. One vision. One hospital.

The Hospital Research Unit (HRU) of the UST Hospital (USTH) envisions that by 2011, all of their 60 and counting clinical studies will have published, locally and internationally.

The Institutional Review Board (IRB) of HRU, which reviews and approves studies, said that there are a total of 60 (32 in-house and 28 pharmaceutical company-funded) studies under their department. The studies were reviewed and approved based on the ethical and legal standards mandated by the Declaration of Helsinki.

The Declaration of Helsinki was developed by the World Medical Association in June 1964 to provide guidelines on ethical medical research involving human subjects. It emphasizes the physician’s duty to ensure the patient’s welfare.

According to Dr. Graciela Gonzaga, head of the IRB, the studies are reviewed primarily on two criteria, legal and ethical.

“When we say ethical, legal, and with a good design, we mean very strict criteria. For example, when we talk about efficacy of a drug, we look for randomized controlled trial, except for drugs meant for very rare diseases,” she said.

According to Gonzaga, good research design employs logical variable manipulation and statistical analysis that enable a rational explanation of the results.

The USTH currently houses three research flagships on neurology and psychiatry, clinical pathology, and anesthesiology.

Studies on the department of neurology and psychiatry dwell on the clinical procedures and preventive measures for stroke patients. While studies on the department of clinical pathology and the department of anesthesiology highlight the evaluation of medical procedures and drug efficacy wherein two drugs of the same medicinal effect are compared to one another.

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Last year, gastroenterologist Dr. Jose Sollano, together with other researchers, conducted the study, “A Comparison of Entecavir and Lamivudine for HBeAg-Positive Chronic Hepatitis B,” which was accepted by the United States Food and Drug Administration and published in the New England Journal of Medicine.

The study compared the efficacy of two Hepatitis B drugs – entecavir and lamivudine. It involved 715 patients, randomly assigned to both treatments.

Although the USTH produces numerous quality studies, Gonzaga said that studies should focus on finding a cure for diseases that seriously concern public health.

Gonzaga also said that USTH has a problem with the application of the research knowledge that has been accumulated.

“We have a problem with knowledge management and knowledge translation. We are still in research, but in other countries, they are already in application,” she said.

And such is the aim of HRU – that in less than 60 months, all their studies would be an open book, ready to ensure people’s health. A. P. P. Bantolo and C. G. Patacsil


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