Clinical trials are experiments or observations done in clinical research. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on safety and efficacy. Depending on product type and development stage, investigators initially enroll volunteers or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. Clinical trials can vary in size and cost, and they can involve a single research center or multiple centers, in one country or in multiple countries. Clinical study design aims to ensure the scientific validity and reproducibility of the results.

Costs for clinical trials can range into the billions of dollars per approved drug. The sponsor may be a governmental organization or a pharmaceutical, biotechnology or medical device company. Certain functions necessary to the trial, such as monitoring and lab work, may be managed by an outsourced partner, such as a contract research organization or a central laboratory.

Trending for the last five years, there has been a shift of clinical trial conduct towards ASIA-PAC. Key challenges faced in US and Europe includes:

In the next 5 years, ASIA-PAC will be the sponsor's destination in the conduct of their research and development of their drug and devices mainly due to the following factors:

Facilities

Clinical Trial Unit is to be housed in the West Wing of the Lower Ground Floor of Nursing Tower of TMC, Pasig. Current Clinical Trial Unit Administrative Office is at 17th Floor, Nursing Tower, TMC. To guide the clinical trial staff in using the Clinical Trial facility, you may refer to these guidelines (please click the link).

Staff

• CTRI Director- Raul V. Destura, MD, MBA
• Clinical Trial Unit Head- Edgar R. Dimaguila, RMT
• Clinical Research Coordinator- Maria Theresa P. Regaliza
• Administrative Assistant- Newel P. Villareal

The Medical City is home to over 100 GCP-certified principal investigators and research staff from different specializations and departments. It also maintains a pool of Study Coordinators that the investigators can tap for their research needs. It also offers world-class laboratory and imaging services that is at par with the global requirements for the conduct of clinical trials. The Medical City also boasts its own Institutional Review Board, with a Level III accreditation in local and regional ethics regulatory boards, that caters to all TMC Network clinical trial sites.

Since the CTU’s establishment in 2017, The Medical City has engaged and continuously attracted pharmaceutical, biotech and biosimilar companies to do their clinical trials at The Medical City and its network sites. The CTU also strives to have a strong partnership with various local and international Contract Research Organizations which further streamlined the overall conduct of clinical trials in the Philippines.

The CTU is in collaboration with the Philippine Foundation for Health Research and Development, Inc. for receiving and disbursing research-related funds for clinical and biomedical research. To learn more about this process, you may click this link.

To learn more about our on-going clinical trials you may click this link.

To learn about TMC's ethics review process, you may click this link.

To know our process workflow for processing industry-initiated studies and clinical trial agreement, please click the corresponding links.

CTRI Iloilo

The Clinical and Translational Research Institute Iloilo (CTRI – Iloilo) is the first satellite branch of CTRI in the Western Visayas region established in 2017. It serves as a platform where researchers, scientists and clinical trialist of various professions work together for advancements in healthcare and its delivery models. CTRI – Iloilo provides technical, ethical, operational and financial research management assistance in order to facilitate efficient and quality healthcare researches. It operates under and is supervised by the Medical Services Division.

All processes of the unit are aligned withinternational standards following good clinical practice guidelines - International Conference on Harmonisation (GCP-ICH) and Laboratory Biosafety Practice contributing to high quality control. We follow a centralized ethical review for all protocols where the Institutional Review Board (IRB) is level III PHREB accredited.

CTRI Iloilo is part of the Western Visayas Health Research and Development Consortium (WVHRDC) and partners with the academe,government agencies, private organizations and international research institutions for research and development – and further into its applicability in the healthcare practice.

CTRI Iloilo Director- Ma. Sancha Pauline A. Garcia, MD

Clinical Trial Unit, Head- Marie Grace Dawn T. Isidro, MD

CTRI Manager- Patrick Joseph B. Jalandoni, RN

Research Coordinator- Bea Nestie Angeli L. Villareal, RN

Nurse Informaticist- Webster F. Padernal, RN