CROs Need Digital Health & AI to Navigate the Shift to Decentralized Clinical Trials
A look at the paradigm shift from clinical trials to decentralized clinical trials that is pushing CROs to adopt digital health & AI.
The rise of mainstream virtual care and patient consumerism, and now AI/ML is impacting every aspect of healthcare, including clinical trials (CT). This demands more investment in Digital Health technologies to support a shift towards a more decentralized model that began in 2010s and became essential during the pandemic. An analysis of the open-source intelligence of digital health and clinical trials over the last year highlights the close connection between the two areas, highlighting the shift to decentralization (Figure 1). Since the 2019 pandemic, Decentralized Clinical Trial (DCT), have become a fast growing model to engage & retain more patients, improve data quality, and increase access to patients in rural areas.
The Global DCT market size is projected to reach $16.3B by 2027, from $6.1B in 2020, at a CAGR of 14.8% during 2021-20272. This presents a significant opportunity for early investment for CROs.
Consequently, the partnership dynamic between pharmaceutical & biotechnology (sponsors) and their partner Contract research organizations (CROs) that support their clinical trials is changing. Traditionally, companies engaged CROs to commission specific projects to augment their internal capabilities. However, in recent years, CROs are delivering more integrated services that embed them into more functions within their partners.
Additionally, CROs have become increasingly important in recent years to reduce the cost and time of development, and to improve the success rate of clinical trials. This requires CROs to anticipate the demand of their partners more accurately.
Here we look at the paradigm shift from CT to DCT that is pushing CROs to adopt digital health and AI to respond to the evolving landscape of clinical trials.
A Shift from a Centralized to a Decentralized Model
Traditionally, clinical trials have been conducted in centralized locations, such as hospitals and research clinics. This requires patients to travel to the trial site for all of their visits and procedures. This can be inconvenient and costly for patients, especially those who live in rural or underserved areas.
DCTs, on the other hand, are conducted remotely, without the need for patients to travel to a clinical trial site. This can be done using a variety of digital health technologies and AI-assisted solutions such as e-consent, remote patient monitoring (RPM), telemedicine, and wearable devices. Overall, transitioning the traditional CT model to DCT requires updating and introducing new technologies, holistic systems, and workflows for patients, sponsors, and providers. This means the trial sponsors and CROs need a digital transformation and AI transformation strategy to succeed.
DCTs offer a number of advantages over centralized clinical trials, including:
Convenience: DCTs are more convenient for patients, as they can participate in the trial from their own homes or other decentralized locations. This can reduce the burden on patients and make clinical trials more accessible to a wider range of people.
Cost-effectiveness: DCTs can be more cost-effective than centralized clinical trials, as they reduce the need for patients to travel and stay in hotels.
Diversity: DCTs can help to recruit more patients from diverse backgrounds into clinical trials. This is because patients do not need to travel to a central location to participate in the trial.
Sponsors are increasingly adopting AI and digital transformation strategies within their organizations and expecting their CRO partners to deliver in this area as well.
CROs Need an AI Strategy for the New Era of Digital Health
Since 2021, as the fog of the pandemic is clearing, more resources and attention are being provisioned to the digital health, and AI in healthcare (Figure 2). Interestingly, CROs have become more in demand during the pandemic onwards as they supported Pharma in a variety of clinical research including vaccines for COVID-19. To lesser extent but nonetheless, the topic of AI in Healthcare is beginning to rise as leveraging generative AI is becoming an area of focus for many organizations.
CROs are well-positioned to utilize digital health solutions to keep up with the interest of healthcare professionals (HCPs), patients, and partners. Here are some strategies and reasons to invest in digital health:
To further advance in this area, a CRO’s digital strategy should consider what AI-based solutions can further add to the application of digital health and other components of the DCT to improve experience and outcomes. Here are some areas where AI can be valuable:
Identify and recruit patients: AI can be used to identify and recruit patients who are eligible for DCTs. This can be done by analyzing large datasets of patient data, such as electronic health records, to identify patients who have the right characteristics for the trial.
Monitor patients: AI can be used to monitor patients remotely during DCTs. This can be done using wearable devices, smartphone apps, or other digital health technologies. AI can be used to analyze the data collected from patients to identify any potential problems or adverse events.
Collect and manage data: AI can be used to collect and manage data from DCT participants. This can help to reduce the burden on patients and improve the efficiency and accuracy of data collection.
Analyze data: AI can be used to analyze clinical trial data more efficiently and effectively than traditional methods. This can help to identify trends and patterns that may not be visible to human analysts.
Overall, AI has the potential to revolutionize the way that DCTs are conducted. By using AI, CROs can improve the, effectiveness, and quality of DCTs. Effectively combining digital health and AI can help CROs leads to better outcomes for patients and sponsors; therefore, becomes a key component of running successful clinical trials.
Feel free to email me or reach out on LinkedIn to discuss how your organization can implement AI and digital health strategies that is right for your organization.