An interview with Edwin Ng, APAC SVP & GM at Medidata Solutions on growth opportunities in the clinical trials industry in the APAC region.
Between 2017 to 2022, there has been considerable growth in the global clinical trials arena. Of almost 27,000 clinical trials launched in 2021, almost half of them are located within the APAC region. With this growth expected to continue in the coming years, how can we tap into those opportunities and drive business growth? Here, we speak to Edwin Ng, APAC SVP & GM at Medidata Solutions to learn more about clinical trials and its growth opportunities in APAC.
1. How have clinical trials changed over the years?
Traditionally, clinical research has been largely reliant on physical clinical trial sites, including hospitals, medical centres, and laboratories, which made the process expensive. The geographical restriction is a challenge for researchers who face physical constraints to patient recruitment as well as patient engagement. Clinical trials can be a burden on patients, including lost days from work for site visits, travel costs to get there, and strain on patients and their caregivers to devote time and energy to participate. During COVID-19, 70% of clinical trials suffered setbacks like slower patient recruitment and delayed clinical processes, affecting thousands of patients.1 This encouraged the industry to look for avenues to digitalise trials.
When patient and study data can be accessed electronically or virtually, research and business continuity is ensured, and patient recruitment and engagement are improved. Virtualised trials run by using technologies and digital tools that allow patients to remain at home – for example, using apps to track patient symptoms and leveraging video tools to allow researchers to remotely engage with patients in real-time.
Merging technology, such as patient portals and wearable technology that support virtual trials and digital processes have brought studies outside the traditional lab settings. Digitisation allows for remote access to trials for patients, increased connectivity for data sharing, improved accuracy in patient monitoring and data assessment.2 It has also removed the reliance on paper documentation for data. All these factors lead to a reduction in inefficiencies and costs while accelerating the pace of study.
It is no surprise then that there has been an uptake in digitisation of clinical trials since the pandemic. Solutions like Medidata Patient Cloud, Rave EDC and Medidata remote monitoring are transforming the clinical trials industry. Virtual clinical trials expanding at a (CAGR) of 5.7% from 2022 to 2030.3 50% of clinical trials will incorporate wearables and sensors by 2025, vs 10-15% at present.4
2. According to GlobalData, of the trials planned for 2022, APAC had the bulk of the clinical trials with 54%. Why is this the case?
This trend has persisted since before the COVID-19 pandemic, indicating sustainable growth in APAC and a resilient market for clinical trials. Between 2017 and 2019, APAC saw more growth than other major markets, reaching 12.1% while the US and Europe didn’t exceed 2% growth.5
With sophisticated healthcare systems, a skilled workforce and a diverse pool of patient participants across many countries, APAC offers a larger urban population than the US and Europe, while hosting a growing number of trial sites. APAC’s trial site density, an important metric that indicates a region’s potential for growth, is 3.1 trial sites per million urbanised population, compared to the next lowest density, 22.2 trial sites per million in Europe.5
There has also been an increase in disease prevalence across APAC with the rise of chronic and infectious diseases and certain types of cancers, which represents a significant opportunity for clinical trials.
Penetration of wearable medical devices in Asia-Pacific is expected to increase by 26.7% in 20276 – making it well suited for decentralised clinical trials (DCT) that reduce the drug development period, cut costs, and improve patient access to clinical trials.
Countries like South Korea, China, Japan, and India are strategically important markets for many global pharma companies and therefore, patients from these countries are often included in global trials.
Additionally, some governments in the region are enrolling supportive initiatives aimed at supporting the clinical trials, life sciences, and healthcare industry
- g., Australia: Australia’s sophisticated clinical trials infrastructure, streamlined regulatory approval system, and grants and incentives attract the clinical trials industry.
- Through the Medical Research Future Fund, nearly 200 ground-breaking medical research projects will share in more than $382 million in grants, including more than $32 million to improve First Nations health.7
- Nationwide rollout of National Mutual Acceptance (NMA) scheme has ensured regulatory and ethics approval are streamlined which has accelerated the pace of research efficiently.8
- g., Singapore: Coupled with its availability of a diverse pool of clinical trial patients and easy access to the region and is poised to capitalize on its unique position as a launchpad of Asia for innovation
3. Are there any challenges faced by clinical trials in the APAC region, and how are they different from those in other regions?
Clinical trials at an industry level are difficult to manage because of our rapidly changing trial ecosystem. Companies must navigate different realities of multiple countries for efficient drug or solution launch, and these realities keep changing over time. As a result, clinical operations must evolve at the pace of the research it supports, in APAC or any other part of the world. We have seen that optimised trial operations evolved for effective communication and information sharing can help to overcome many drawbacks of traditional clinical operations practices that rely on manual data entry within multiple siloed locations, which creates a risk that key activities and actions will be missed. Augmenting risk-based quality management (RBQM) principles can help companies to fare better with holistic end-to-end solutions rather than point solutions.
The amount of data the industry is working with has increased. Data points collected in Phase III trials have increased threefold in the last 10 years, reaching an average of 3.6 million.11 This trend will undoubtedly continue, with 70% of trials expected to incorporate digital health technologies including high-volume and high-velocity wearables and sensors in the next few years. This has created significant data management challenges, as traditional clinical data management technologies and manual processes to review, clean, and lock data have not progressed as fast. Data is often managed with tools and processes that are not able to work at the speed required to support the realities of today’s clinical trials. Clinical Data Management Systems (CDMS) need to support digitalisation to collect, validate, and transform their data across the lifecycle of a trial, including study design, planning, conduct, closeout, and post-trial analysis.
Historically, one of the global hurdles for clinical trials is that the regulatory systems are not harmonised – APAC is no different. One of the key success factors for APAC’s clinical trials industry is going to be the ability to tap into a diverse patient pool, which will be difficult to scale if the regulatory considerations are different from country to country. Today, we have the tools to digitise and run clinical trials in multiple countries simultaneously, where practitioners can see the data coming in from multiple sources in real-time. As soon as data is entered into the system, all users have access; a principal investigator is able to sign off the data, a CRA is able to review it remotely without coming into the site, and a data manager can then approve the data, and the sponsor or CRO is able to track the study’s progress.
We as an industry need to advocate for a universal regulatory ecosystem and to provide solutions that can help companies navigate themselves through this current environment. For example, device manufacturers, with increasing frequency, are being required by FDA to implement a tracking system for certain types of devices across the value chain to facilitate notification in the likelihood of a recall. Most medical device trials are still relying on manual efforts to track devices whereas randomisation and trial supply management solutions can be very easily implemented to solve this issue.
4. What are the future trends in clinical trials in the APAC region and what can we expect in the years to come? And given these opportunities, how does Medidata plan to drive business growth in the region?
We know that future trials–in APAC and across the world–will not look or perform the same as they have in the past. Technologies must be able to support digitalisation of clinical trials such that it addresses the current challenges of the industry while also being future-ready in our ever-evolving ecosystem.
Medidata provides end-to-end solutions – pre-trial design improvement solutions, tools for patients’ engagement, cloud solutions for effective data sharing and AI that can unearth insights. The impact that digital solutions can bring at every step of the clinical trials journey can accelerate patient recruitment and enrolment, improve patient diversity, and increase medical research participation while decreasing patient burden through more options and greater choice.
Trials leveraging AI technology and big data in the planning phases can optimise trial design and help researchers identify target patient populations, allowing for more efficient matching of trials to patients. A unified platform, advanced analytics and deep human expertise enable our AI tools to uncover insights that have helped many researchers make better clinical decisions.
Digitisation allows for patient-centricity – with remote access to trials for patients, increased connectivity for data sharing, and improved accuracy in patient monitoring and data assessment is possible. Considering participants in clinical trials come from all walks of life – ease of usage of digital tools can help in the enrolment and retention of participants. Medidata’s single destination patient portal was built to provide greater flexibility to patients – solutions from electronic consent forms, intuitive model for capturing patient data and cloud-enabled data storage has made patients’ participation in trials smoother.
Solutions like Medidata Patient Cloud, Rave EDC and Medidata remote monitoring have transformed the clinical trials industry. Utilising Integrated Evidence like Acorn AI can give clinical development leaders and their trials the best chance at success–from a better-designed trial to a more robust control, to stronger positioning of a drug for commercialisation–the rich context and evidence required in a rapidly evolving clinical development landscape. [APBN]
This article was first published in the June 2023 print version of Asia-Pacific Biotech News.
About the Interviewee
Edwin Ng, APAC SVP & GM, Medidata Solutions
Edwin joined Medidata in 2014 and heads the Life Science industry of Dassault Systemes across the Asia Pacific region. Under Edwin’s leadership, the company’s business in the region has recorded significant year on year growth and achieved multiple leadership positions and awards in different countries. With the push for transformation in the healthcare sector through digitalization, Medidata is committed to serve our sponsors and partners by continued investments in the APAC sales, marketing, solution consultant, professional services and customer support teams.