Revolutionising Healthcare Research with Digitalised Clinical Trials
Tom Doyle, Chief Technology Officer, Medidata
This article explores the digitalisation of clinical trials, focusing on the sector's current landscape, challenges, and opportunities. It discusses how digital tools and platforms transform the clinical trial process, from patient recruitment to data collection, improving efficiency and accuracy. The article also discusses Asia's strong potential as a market for clinical trials with its wide and diverse population.
Clinical trials are a crucial part of the healthcare system and are a platform for research studies to explore new ways to prevent, detect or treat disease. Though clinical research is the root of medical advances, the process is typically lengthy and costly, with success rates being low in most instances. It is estimated that only one in 5,000 to 10,000 candidates in traditional new drug development successfully make it to market, in a process that takes an average of about 15 years1. With rising healthcare needs, stakeholders in the clinical trials space must look at implementing technology to accelerate new drug development to improve the health of our global population.
As the industry embraces digitalization in clinical trials, new technology is reducing friction in electronic data collection and management, remote participation, data analytics and artificial intelligence (AI). The result is enhanced data quality, cost efficiency, and faster recruitment – enhancing speed, predictability and accuracy. By understanding the role of technology in clinical trials, stakeholders can better understand its transformative impact on healthcare.
Asia-Pacific’s potential on the global clinical trial stage
The size of the clinical trials market is anticipated to reach approximately US$ 887 billion by 2032, growing steadily at a compound annual growth rate (CAGR) of 7.2 per cent from 20242. Through increased digital transformation, AsiaPacific (APAC) has the potential to position itself front-and-centre, as a key destination for efficient clinical trials on the global stage.
The region already has the right foundation. In 2022, 58 per cent of all global Phase I clinical trials were attributed to APAC3, and the number of trials taking place here is seeing steady growth from 11,571 in 2019 to 14,346 in 20234. There are multiple key drivers for this strong foundation, including countries within the region investing in and having strong research and development (R&D) capabilities, a wide talent pool, world class healthcare infrastructure, and robust regulatory and ethical standards. Other attractive initiatives span updated processes to reduce barriers to drug development processes, making it more manageable for companies to conduct clinical trials and increased investments in technology and infrastructure.
With numerous blockbuster drugs seeing their patents expire in 20245, we will witness heightened competition among global pharmaceutical companies, and through digital transformation, countries within APAC can make sure they are part of the game. Highpotential countries like India and China, for example, have promising population and economic growth prospects that will spur increased investments in the region from multinational pharmaceutical companies. From a regulatory standpoint, countries across APAC are also actively aligning their clinical trial regulations with global standards. Simplifying approval processes and strengthening ethical standards are key catalysts for increasing the number of global clinical trials conducted in the region. The region’s technological excellence coupled with regulatory standardisation is critical to its growth as a central hub for global clinical trials. This is expected to lead to increased research activities and attract further investments in the future.
The digital transformation of clinical research and the emergence of DCTs
The use of digital health technologies such as wearables and mobile apps, continues to rise. These tools are driving digital transformation by enabling decentralised clinical trials (DCTs), such that patients can participate remotely from home – also sometimes referred to as remote, hybrid, virtual, or patient-centric trials. This improves data collection and monitoring as patients can provide more data in real-time and they are not bound by the necessity of being physically present in a specific site. By reducing geographical barriers, this shift not only enhances trial efficiency but also helps to reach a broader and more diverse patient population regardless of their actual location.
DCTs have not entered the mainstream yet in many countries, but adoption was accelerated during the height of the pandemic as trials experienced severe decreased enrolment or were halted altogether due to diminished patient ability or willingness to visit sites, delays in trial activities, and difficulties adhering to protocols6. This situation forcibly expedited a shift to using virtual methods for many trials, allowing for their continuation and demonstrating the industry’s ability to quickly adapt to this new environment in a matter of weeks to months7.
Unlocking opportunities with DCT
Traditional clinical trials have relied heavily on research sites acting as central locations, leading to long travel times to attend visits. This can be a barrier for patients looking to participate in life-saving trials. The decentralised trial model uses patient-facing technology to move trial activities outside central research sites and into patients’ daily lives. This shift lessens the burden of trial participation for both patients and sites, enhancing the overall clinical trial experience, while breaking down barriers and reducing costs.
One of the biggest opportunities to unlock with DCTs is participant study completion. Decentralised or hybrid trials empower these patients to participate with more ease and flexibility using technology, saving time on their trial activities and offering secure experiences. What’s more, they can also increase recruitment by expanding participation to patients across larger geographic regions, and including those with special needs or busy schedules who might not have otherwise participated in a traditional trial. The patient-centric nature of DCTs also enhances patient retention and engagement and improves patient experiences compared to traditional trials because they are more convenient, can reduce the likelihood of missed appointments, and tend to inspire more engagement and dedication in patients.
Another opportunity is giving CROs and sites real-time data to improve the accuracy of trial results. Today, patients have more technology in their hands than ever before, and they’re comfortable using it.
Using smart or mobile health applications and wearable devices can help with data collection, which can then be accessed and managed in real-time through integrated platforms. The continuous monitoring of patient health metrics provides researchers with valuable real-time data which can improve the accuracy of trial results.
Innovations in DCT technology not only help to relieve patient burden, but, by increasing access to clinical trials, they also ensure that the clinical trials represent the populations who will receive these treatments in a realworld, commercial setting. Digital tools and methods, both core to DCTs, are modernising clinical trials by combining complementary data streams, such as subjective patient-reported outcome (PRO) data, with objective data arising from such wearables. These combined data streams provide novel insights by yielding highly comprehensive patient profiles that were not readily obtainable in the past.
Using a decentralised trial model also means that patients would likely have remote access to all their clinical trial needs through a single web-based portal. A unified ecosystem of tools allows sponsors to monitor clinical trials while unifying all data on one platform to improve the speed and quality of data captured. Breaking down data silos empowers healthcare stakeholders to overcome the complexities of modern clinical trials and foster collaboration on cleaner, more actionable data. With this, researchers can identify potential data issues faster and gain a more accurate understanding of the patient.
Overcoming potential challenges
While the benefits of digitising clinical trials are clear and can help advance medical research, the process does not come without challenges. For example, regulatory hurdles will vary across different countries with their respective regulatory bodies, and there is currently no global minimum standard. This could present challenges, adding both complexity and costs to cross-border trials.
That said, it is positive that regulators, such as the United States Food and Drug Administration (FDA), are increasingly focused on the patient perspective in clinical trials and real-world evidence (RWE) to help evaluate treatment effectiveness. Digital initiatives and guidance documents collectively suggest that DCTs will play an increasingly important role in the future of clinical trials. For instance, in their draft guidance on heart failure, the FDA explicitly discussed the use of accelerometery as a novel endpoint that will be considered a measure of heart failure and to assess the effects of treatment8.
Patients may also experience data privacy and security concerns, especially since clinical trials handle sensitive health data that must be protected. Having personal data and health records stored digitally may raise questions about the access different stakeholders may have to sensitive data. It is crucial that when clinical trials turn increasingly digital, the relevant systems not only adhere to data protection and privacy laws, but meet ethical standards to build trust with patients and stakeholders. For example, AI systems, with access to vast datasets, have the opportunity to revolutionise medicine while requiring thoughtfulness and focus on data privacy and security. Ensuring transparency and ethical AI approaches together with compliance with laws like Europe’s General Data Protection Regulation (GDPR), the USA’s Health Insurance Portability and Accountability Act (HIPAA) or Singapore’s Personal Data Protection Act (PDPA) is critical.
When it comes to deploying AI, researchers could also encounter multiple difficulties. Many clinical trial environments use legacy systems that may not be readily compatible with newer AI technologies. Integrating AI into such systems can be technically challenging and costly. The initial setup and operational costs for AI in clinical trials can be high, especially in less-funded studies or institutions. This could potentially limit the adoption of AI and make some organisations slower to digitalise clinical trials than others. Introducing AI technology in traditional clinical trials also presents a learning curve for existing staff. Potential skill and understanding gaps in the current workforce must be addressed in parallel, and clinical researchers must have the transparency and training to use and trust AI technology.
The global DCT market is projected to grow from US$ 8.19 billion in 2024 to US$ 24.97 billion by 20329. As clinical trials continue to evolve and become modernised by integrating more virtual elements, the landscape is becoming more competitive, making the adoption of such technologies across countries and studies critical. Sponsors must prepare themselves for this increasingly digital future, which will demand scalable, flexible, interoperable, unified, and intelligent software platforms to synthesise patient-centric data into real-time insights that will offer benefits to stakeholders across the healthcare spectrum. These technological advancements also reinforce the importance of collaboration and transformation to create smarter treatments and accelerate the delivery of new therapies—leading to healthier populations.
Foot Notes:
1 National Institute of Food Drug Safety Evaluation (NIFDS) (2023). Food and Drug R&D Issue Report (AI-based New Drug Media interview Briefing Book for Ruthie Davi.docx Development).
2 Yahoo! Finance (2024). Clinical Trials Market Value to Reach USD 887.0 Billion by 2032: Boosting Opportunities for Medical Research and Patient-Centric Innovations.
3 Clinical Trials Arena (2023). Asia-Pacific dominates Phase I clinical trials: a trend analysis.
4 Global Market Insights (2024). Clinical Trials Market - By Phase (I, II, III, IV), Study Design (Interventional, Observational, Expanded Access), Service Type (Outsourcing, In-house), Therapeutic Area (Oncology, Dermatology, Neurology, Cardiology) – Global Forecast (2024 – 2032).
5 PharmaVoice (2024). 3 patent expirations in 2024 and how companies are pivoting.
6 Outsourcing Pharma (2020). Medidata analysis shows COVID-19 impact on trials.
7 JAMA Network (2020). Preserving Clinical Trial Integrity During the Coronavirus Pandemic.
8 U.S. Food and Drug Administration (2019). Treatment for Heart Failure: Endpoints for Drug Development Guidance for Industry.
9 Business Research Insights (2024). Decentralized Clinical Trials Market, Size, Share, Growth, and Industry Analysis, By Type (Interventional, Observational, Expanded Access), By Application (Oncology, Cardiovascular, and Others), Regional Insights, and Forecast From 2024 To 2032.
Author Bio
Tom Doyle, CTO of Medidata, has been advancing technology in life sciences for 20+ years. Across numerous leadership roles, Tom’s focused on transforming experiences for patients, sites, and sponsors. He champions data and AI for surfacing new insights and accelerations that lead to better patient outcomes and clinical trial efficiency.
