Pointwest Holds Clinical Trial and Clinical Research Forum
June 16, 2016
To stimulate ideas and provide a comprehensive overview of clinical research, Pointwest conducted a 3-hour Forum on April 15, 2016 at Pointwest Building, UP-AyalaLand Technohub, Quezon City. Registered Pharmacists, Data Scientists, Software Engineers, Pointwest Healthcare Managers, and Pointwest President Beng Coronel attends the event with the theme “The Economics of Clinical Trials in the Philippines.”
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. The trials include new treatments and known interventions that warrant further study and comparison. Said studies 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 Clinical Research Organizations (CROs).
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 CROs 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.” Paul Edward Tajon, Speaker from Bureau of Investment
From the collection, detection, assessment, monitoring, and prevention of side effects with pharmaceutical products, CROs provide services such as clinical research, clinical trials data management, data entry and validation, medicine and disease coding, quality and metric reporting.
Philippine Setting: An 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 impressive growth.
“We have seen full potential in the Philippines,” Tajon said. “Despite the country’s geography which sometimes makes it tough to deliver or process required drugs, we still have the capability to provide advanced standards, since we have a lot of educated healthcare resources who are widely English-speaking, ” he added.
Moreover, the information technology and business process management (IT-BPM) industry in the Philippines has grown at an annual rate of 30% over a decade (as per the Department of Science and Technology). 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 of Clinical Research
Because there is no single government agency for trial approval like FDA, Bureau of Quarantine and PDEA, timeline of approval becomes unpredictable. The government must provide an inclusive support to regulate this clinical trial.
Going into Clinical Research Phases
Mr. Rodmar Pulido, guest speaker from Philippine Clinical Research Professionals (PCRP), discusses further the clinical trial phases. Such phases are important in finding enough evidence for a process of medical treatment, from animal testing to human subjects to determine if the trial seems safe, useful, or the presence of 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.” Rodmar Pulido, Vice President of PCRP
With extensive 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
As the Vice President of PCRP, Pulido also urged Pointwest to be a member of the organization. PCRP is an association composed of Filipino clinical research professionals from the academe, pharmaceutical industry, contract research organizations, and other groups involved in clinical research.
The conduct of the said event was made possible with the collaborative efforts made by the Learning and Development Team and Pointwest Healthcare.
Founded in 2003 by pioneers of the Philippine Global Sourcing industry, Pointwest creates value for its list of satisfied clients — including top Fortune 100 and local companies — with world-class IT and BPM services backed by international-standards methodologies and innovative practices.