May 4, 2023
On April 26, PiVOT’s General Manager, Mr. Rodmar Pulido, was invited to share his valuable insights as a panelist in the 25th Anniversary of The Vaccine Study Group held at the College of Medicine, UP Manila. The event focused on “– Ethical issues on conducting vaccine trials in the midst of a pandemic” and “The Future of Vaccine Trials in the Philippines,” in which Mr. Pulido’s contribution was particularly noteworthy.
During the discussion, he emphasized the future of the Pharmaceutical industry and its potential growth in two countries – the United States and China. Mr. Pulido cited clinicaltrials.gov data indicating that 40% of total Phase 1 studies registered in 2021 come from the United States and 40% from China, with Europe accounting for the remaining 20%.
GROWTH IN VACCINE TRIALS
He highlighted some key insights, including the significant growth of vaccine trials in the Philippines, which saw a 300% increase from 2018 to 2021. He also mentioned Indonesia’s impressive 500% growth from 2008 to 2021, despite not conducting clinical trials in 2018. This highlights the growing competition in the region, including Vietnam, Singapore, Malaysia, and Indonesia with its rapidly expanding population of around 200 million.
ARTIFICIAL INTELLIGENCE (AI)
The panel has also discussed the role of Artificial Intelligence (AI) in reducing costs and patient numbers. He explained how AI can detect endpoints faster than traditional trials, and gave an example of how it can reduce patient numbers by conducting a meta-analysis of other clinical trials and merging the data. This innovation could revolutionize the way clinical trials are conducted, paving the way for more efficient and effective processes in the future.
The use of AI data can lead to fewer monitoring visits as it can drive quality and extract necessary information remotely. However, to fully leverage this technology, it’s crucial to have a strong site infrastructure. This includes integrating sites with institutions, which are business enterprises that have governance, accountability processes, and standardized operating procedures (SOPs). With a stronger site infrastructure, we can enhance data quality and minimize the need for study monitors, allowing for more efficient operations and better outcomes.
DIGITALIZATION
Electronic Data Capture (EDC) is the first technology used in clinical trials. However, EDC is not only about data entry, it can also provide you with valuable trial information such as data quality. By leveraging EDC, both as a site and from the patient’s perspective, you can unlock its full potential. The digitalization of clinical trials aims to effectively manage the ever-increasing amount of data being collected. In just the past 10 years, the number of data points has exponentially increased, making it crucial to utilize EDC to its fullest potential.
REAL WORLD DEVELOPMENT/REAL WORLD EXPERIENCE (RWD/RWE)
Regulatory authorities worldwide have acknowledged the potential of Real-World Experience (RWE) and Real-World Development (RWD) data in approving marketing applications. However, in the Philippines, the lack of digitalization of healthcare data poses a challenge in utilizing RWD/RWE data for marketing purposes.
THE FUTURE OF THE PHILIPPINES
The United Kingdom is taking steps to solidify its dominance in the field of Clinical Research with a 2021-2025 program focused on the Future of Clinical Trial Delivery. Taking inspiration from their approach, the Philippines may consider similar strategies to advance its clinical trial industry. The UK’s program includes a comprehensive census of all clinical trial practitioners, with 7,000 nurses currently in the profession.
Additionally, they are targeting programs to engage new nurses and midwives in clinical trials and research and have established an associate Principal Investigator program for midwives, nurses, and other health professionals. The program also seeks to integrate clinical trials into the healthcare system and patient care, with the establishment of a Clinical Research Network or Trial Center targeting 80% delivery on time for their trials. By implementing similar measures, the Philippines can aim to elevate its clinical trial industry to new heights.
(From L-R: Dr. Benjamin Sablan, Dr. Josefina Carlos, Dr. Edlyn Jimenez, Rodmar Pulido, Dr. Lulu Bravo, Dr. Rosario Capeding, and Dr. Charles Yu)
Attendees, moderators, and panelists of Vaccine Study Group’s Seminar Workshop
“Opportunities and Challenges for Vaccine Trials in the Philippines”
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