RITM Press Statement Related to its Conduct of Scientific Researches and Clinical Trials
Posted on  by Communication & Engagement Office

19 JANUARY 2018 | MANILA, PHILIPPINES — The Research Institute for Tropical Medicine (RITM) is a research arm of the Department of Health for public health research. RITM was established in 1981 thru Executive Order No. 674 s. 1981 with the following functions:

  • Undertake research activities in the diagnosis, control and prevention of tropical diseases that are major causes of mortality and morbidity in the Philippines
  • Conduct clinical trials aimed at better understanding and control of tropical diseases
  • Conduct regular training courses for medical and paramedical personnel in the control of common tropical diseases in the country
  • Provide high quality tertiary care to both in-patients and out-patients suffering from tropical diseases included within the scope of the Institute’s research activities
  • Participate in the technical cooperation program with the Japan International Cooperation Agency in research activities in the diagnosis, control and prevention of tropical diseases
  • Arrange for the participation of the National Science Development Board and the UP System Health Sciences Center in the planning and implementation of the program of the Institute
  • Apply for, receive, and accept bequests, grants, and donation of funds, equipment, materials and services needed for the attainment of its objectives

RITM researches may be investigator-initiated, most often grants through competition, commissioned, or industry supported. An independent Institutional Review Board reviews, approves and monitors research proposals following international and national ethical guidelines.

Further grant assistance was extended by JICA to RITM for the equipment, furniture and fixture, and construction of Animal Research Laboratories, Training Center and Residence Hall, and National TB Reference Laboratory in support of its mandate.

In June 1999, the Biologicals Production Service (BPS) was merged with RITM. The RITM mandate then expanded to include biological production.

Since 2000, by virtue of several Department Orders, RITM was designated as National Reference Laboratory (NRL) for the following including additional NRLs in the pipeline:

    1. Dengue and other arboviruses
    2. Influenza and other respiratory viruses
    3. Tuberculosis and other Mycobacteria
    4. Malaria and other parasites
    5. Bacterial enteric diseases
    6. Measles and other viral exanthems
    7. Mycology
    8. Polio and other enteroviruses
    9. Antimicrobial resistance
    10. Emerging bacterial diseases
    11. Confirmatory testing of blood units
    12. Rotavirus and other Enteric viruses
    13. Schistosomiasis
    14. Neglected Tropical Parasitic Diseases
    15. Rabies and other Lyssaviruses
    16. Special Pathogens
    17. Invasive Bacterial Vaccine Preventable Diseases
    18. Public Health Entomology

Since its creation, RITM has been designated to perform specific functions and designations in various capacities. Among these are the following:

    1. WHO-TDR designated Regional Training Center for Good Health Research Practices for the Western Pacific Region (2012)
    2. Philippine National Influenza Center (2014)
    3. National Referral Center for Management of Severe Acute Respiratory Syndrome (SARS) and Other Emerging and Re-emerging Infectious Diseases (2004)

With these mandates, RITM has vigorously pursued its research programs, built up its manpower and laboratory resources, established and expanded formal linkages with local and international institutions, and disseminated research results for application in control program.

RITM ON ITS MANDATE TO CONDUCT TECHNICALLY AND ETHICALLY SOUND SCIENTIFIC RESEARCHES AND CLINICAL TRIALS

The Research Institute for Tropical Medicine (RITM) upholds its mandate in conducting technically and ethically sound research for the prevention and control of infectious and tropical diseases in the Philippines. The Institute maintains that (1) the conduct of clinical trials is part of its mandate in assessing public health interventions, (2) RITM strictly adheres to international and national standards on the ethical conduct of scientific research, and (3) research results produced by RITM remain unbiased and evidence-based.

The development of any new drug or vaccine is critical to the prevention of infectious diseases. Vaccines go through clinical trials where their safety and effectivity are assessed. RITM conducts clinical trials to provide technical information which can help decision makers assess the safe and effective use of these interventions in public health.

The dengue vaccine, now marketed as Dengvaxia, is the product of 23 years of research and 25 clinical studies conducted in 15 countries including the Philippines. The Philippines, through RITM, participated in the CYD14 study which started in 2011 along with four other Asian countries (Malaysia, Thailand, Vietnam, Indonesia) with 10,275 research participants; CYD15 was conducted at sites in 5 countries in Latin America (Brazil, Colombia, Honduras, Mexico and Puerto Rico (USA) with 20,869 research participants. The study provided research data from 31,144 research volunteers, of which 3,501 were from the Philippines.

Prior to and during the implementation of the dengue vaccine clinical trial, the institutional research review boards reviewed the research to ensure the safety of the research participants and integrity of research information. All the researches were conducted under the ethical principles of the Declaration of Helsinki developed by the World Medical Association and is regarded as the cornerstone standard in human research ethics. Additionally, third party research organizations monitored these researches to ensure that the research activities remained within the bounds of Good Clinical Practice.

The RITM researchers firmly stand that the clinical trial on the dengue vaccine was responsibly conducted, uncorrupted by any conflict of interests, has provided accurate and unbiased results, and most importantly, has upheld the safety of its research participants more than its scientific goals.

RITM shall continue providing scientifically sound, and statistically and clinically significant evidence, gathered using international good clinical practice guidelines for public health policy and programs.