To stimulate ideas and provide a comprehensive overview of the clinical trials, Pointwest conducted a 3-hour Forum last April 15, 09:00am-12nn at Pointwest Bldg, Technohub Quezon City with the theme "The Economics of Clinical Trials in the Philippines". The said event was attended by 50 Registered Pharmacists, 10 Data Scientists/I.T professionals, Pointwest Healthcare Managers and Pointwest President Beng Coronel.
Mr. Paul Edward Tajon, guest speaker from the Bureau of Investment, discussed clinical trial as any research study that prospectively assigns human participants to answer specific health-related questions. This trial includes new treatments and known interventions that warrant further study and comparison. The said study can be costly. However, certain functions necessary to the trial, such as monitoring, project management, database design and data analysis tasks, may be managed by an outsourced partner like the Clinical Research Organization
Tajon stressed out that outsourcing of clinical trial activities to CROs, particularly in emerging economies like the Philippines, is a highly effective way for major pharmaceutical companies to streamline its operations.
Economy and Job Creation:
"As the involvement of CRO's continuously arises, industry revenue has shifted its growth ahead of the curve in recent years, from US$14 billion in 2006 to US$25.6 billion in 2015. This means a round of job creation in this economic sector," Tajon said.
From the collection, detection, assessment, monitoring, and prevention of side effects with pharmaceutical products, CROs may provide services such as clinical research, clinical trials data management, data entry and validation, medicine and disease coding, quality and metric reporting.
Philippine Setting Advantage:
The emerging markets of the pharmaceutical industry in the Philippines continue to expand. With the support of the government, technological innovations and talented workforce, the Philippines has seen an impressive growth.
"We have seen full potential in the Philippines," Tajon said. "Despite of the country’s geography which sometimes makes it tough to deliver or process required drugs, we still have the capability to provide advance standards, since we have a lot of educated healthcare infrastructures and people who are widely English-speaking, " he added.
Moreover, according to the Department of Science and Technology, the information technology and business process management (IT-BPM) industry in the Philippines has grown at an annual rate of 30% over a decade. This becomes a perfect avenue for the Philippines to maximize its full potential for the outsourcing of clinical trials.
The Philippines, together with Thailand, has a low labour and production cost compared to its neighboring country like China and South Korea. Tajon asserted that the Philippines is suited to provide quality services around patient compliance and data management through call centers. "In recent years, due to our low-cost goods and services, the Philippines urged several CROs to further their presence to support a pick-up activities in the country".
Challenges:
Because there is no single government agency for trial approval like FDA, Bureau of Quarantine and PDEA, timeline of approval becomes unpredictable. The government should provide an inclusive support to regulate this clinical trial.
Clinical Research Phases:
Mr. Rodmar Pulido, guest speaker from Philippine Clinical Research Professionals (PCRP), discussed further the clinical trial phases.These are important to find enough evidences for a process of medical treatment, from the animal testing to human as a subject to determine if the trial seems safe, useful or there is an adverse effects.
He also said that clinical trials should be scientifically sound, and described in a clear, detailed protocol. "Along with the process, all clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification," Pullido said.
With their outsourcing expertise, Pointwest can take part of the clinical trial process. Part of this is the trial data management which includes:
Data Entry and Processing
Data Quality Checks
Query Management
Data coding and Standards (using MedDRA)
Pharmacovigilance Data Management
Meanwhile, as the Vice President of PCRP, Pullido also urged Pointwest to be a member of this organization. The said organization is an association composed of Filipino clinical research professionals from the academe, pharmaceutical industry, contract research organizations and other groups involved in clinical research.
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The conduct of the said event was made possible with the collaborative efforts made by the Learning and Development Team and Pointwest Healthcare Market Circle.
