Taking stock of the post-pandemic digital trial landscape
It is not breaking news that the COVID-19 pandemic accelerated the adoption of digital technology in clinical trials, with remote (or decentralized) clinical trials becoming more widely used. According to a report by GlobalData, “the number of overall DCT trials has steadily increased from 250 trials in 2012 to 1,293 trials in 2021. The number for 2023 trials is 575 year-to-date and is projected to reach over 1,300 by the end of 2023.”1
Today, the conversation is no longer about what technology can or cannot do for clinical research, but rather, what the optimal ways to leverage digitally-enabled projects are, considerations when designing a study that incorporates a digital component, stakeholders to involve at every stage of the study cycle, and novel opportunities to improve study conduct.
Making sense of the digital opportunity in clinical trials
The use of digital technology in clinical trials has revolutionised the way patients participate in studies and has opened up new avenues for pharmaceutical companies to gather robust data, generate better insights, and ultimately deliver stronger outcomes. Today, digital technology can support patient onboarding, from eligibility screening to electronic consent; It allows for ongoing symptom or adverse effect monitoring, and offers a platform for patients to be informed, educated, and supported throughout studies. Additionally, the shift towards a more decentralized approach has facilitated remote or hybrid clinical trials across a wider pool of participants, and allows for more flexibility in study design. Digitally-enabled clinical studies offer a particularly strong advantage:
For large-scale, international studies: The use of digital trial technology can facilitate the sharing of trial information and real-time data, which can promote transparency and enhance collaboration between study sites, investigators, and patients at scale. In a phase IV study, for example, a significantly larger number of subjects is required. And so, better and faster access to participants and data is essential. In addition, it can reduce the burden on patients and study sites by reducing, and sometimes even eliminating, the need for frequent in-person visits. This reduces the burden on participants and results in reduced study costs, and increased efficiency.
Innovative and modern technologies should also provide the scalability and modularity needed to implement studies at speed and scale, allowing sponsors, investigators, and research organisations to easily deploy studies for new indications, at a greater speed than traditional study design and conduct. Digital technology can also streamline data collection, making it more efficient and less prone to errors than traditional methods. Electronic questionnaires or patient-reported outcomes (ePRO) can be easily administered and recorded, and vital signs or digital biomarkers can be monitored remotely using medical-grade connected devices.
This approach can provide clinicians with more comprehensive and accurate data, helping to inform treatment decisions. A series of semi-structured interviews with 20 European regulators, and summarised in the National Centre for Biotechnology Information of the National Library of Medicine, states that “the key opportunities for Decentralized clinical trials (DCTs) that were recognized by regulators include a reduced participation burden, which could facilitate the participation of underserved patients. In addition, regulators indicated that data collected in DCTs is expected to be more representative of the real world.”2
When participant populations are hard to reach: By expanding the geographic remit of a study and reaching patient populations that may not have been included in traditional trials (due to distance, location, or travel restrictions) clinical studies have an impact on population diversity. In an article published this April in the New England Journal of Medicine3, experts stated that “the goals of increasing diversity in clinical trial participation include earning and building trust, promoting fairness, and generating biomedical knowledge” but also acknowledged that “interest and investment in efforts to improve diversity and representativeness in trials are unlikely to be sustained if the goals of diversification aren’t clearly articulated and understood.”
Providing access to underrepresented populations in clinical trials can be facilitated by the use of remote and digital technologies which reach participants regardless of their location. Equally important is the location of trial sites in relation to target populations: are partner sites optimally located to reach patients with specific conditions? On-site trials that are located far away from key patient populations could miss out on valuable, relevant subjects. Digital platforms can help match patients to clinical trials based on specific criteria, such as their specific therapeutic area or even their genomic profile for example, leading to a more effective recruitment strategy.
When participation is demanding for the patient: By reducing or even suppressing the need for frequent in-person visits, digitally-enabled trials can reduce the burden on patients and make participation feasible for those who have difficulty traveling or taking time off work. For example, chronic diseases or conditions that can severely affect mobility or the capacity to visit a site can be a strong barrier to enrollment and retention. In this respect, digital technologies ensure a better participant-centric experience and focus on inclusivity, allowing population groups to participate from their own homes or local healthcare facilities. The option to onboard caregivers and proxies into digital applications can also support the inclusion of patients who would otherwise struggle to participate. In addition, offering educational content can provide the sense of inclusion, care, and support needed to engage patients throughout the duration of the study.
Thoughts and considerations
Despite the potential benefits of digital technology in clinical trials, there are also some challenges, risks, and limitations to consider. For example, there may be concerns about the security and privacy of patient data, as well as the need to ensure that the technology is accurate and reliable. Ethical considerations should also be factored in, such as defining clear methods to mitigate self-selection bias and digital divide by assessing digital proficiency requirements and taking corrective actions as needed4. Moreover, implementing digital technology in clinical trials may require upskilling of site staff, caregivers and patients to ensure they are familiar with the technology being used. Other potential challenges might include logistical pain points such as drug shipping and management, potentially introducing some level of complexity. Finally, the human factor is not to be ignored: encouraging a leap forward requires thoughtful change management, education and buy-in, and a willingness to innovate at the core.
An effective way to mitigate these challenges is to partner with a trusted technology partner that can support sponsors and investigators on their digitisation journey, beyond the simple provision of digital assets. Regardless of the methodology used, clinical trials inevitably bear a level of risk:
- Inclusion risks, such as the challenges of providing access to digital clinical trials to populations who may struggle to access technology, or failure to consider adequate compensation for participants in a remote construct5
- Efficacy and quality risks in the selection, measurement or technical validation of novel endpoints and digital biomarkers which may impact study validity or efficacy of data collection6 7
- Safety and logistical risks, such as the increased complexity of shipping and delivering treatments or other material to remote patients (for example, temperature-controlled or time sensitive deliveries)
A thorough understanding of the study lifecycle process is required to adequately assess the strengths, weaknesses and opportunities that each method represents. Beyond the hype, it is about engaging with technology stakeholders who will be able to understand your scientific pipeline, study design requirements, and provide valuable, consultative input into your strategy and plans. Not only should the technology be adaptive and easy to prototype, but the people behind it should demonstrate an in-depth understanding of the clinical trial landscape in order to best support the implementation of digitally-enabled studies.
Assessing technology vendors to support digitally-enabled trials
When considering a partner for your digital trial, here are some pointers to help you make the right decisions. Demonstrating mastery in the key areas of technology, security, data management, compliance, clinical operations know-how and patient-centricity can be a good starting point:
- Does the technology provider have a deep level of expertise in clinical research, over and above their digital offering, which can provide guidance on ethical, safety and regulatory considerations?
- Is the technology offered suitable for my particular protocol or therapeutic area? Can it adapt to my current and future needs and can it support participants across the entire study lifecycle?
- Can the technology support rapid and truly modular prototyping from the get go, without requiring extensive coding or development work that could extend User Acceptance Testing periods and jeopardise study design timeframes?
- Is the vendor able to demonstrate their credibility through existing strong partnerships, industry recognitions and evidence generation?
- Can the technology provider demonstrate an impeccable track record in complying with digital and patient security and safety requirements?
- Will the technology allow for a patient-centric experience that will provide the level of support and care for my participants that is to be expected?
- Will the vendor provide the level of knowledge and support that is needed to deploy a digitally-enabled clinical study?
At Huma, we pride ourselves on delivering a combination of clinical and scientific expertise with best-in-breed adaptive and modular technology acquired over 10 years. We believe that technology can be an extraordinary driver of positive change, but also recognise that the people behind it are what makes a big difference in the lives of patients. Today, we put our expertise at the service of pharmaceutical companies, investigators, research and academic organisations to help them run successful clinical trials powered by our technology.
Conclusion
The use of digital technology in clinical trials is growing rapidly and is expected to continue to do so. There is no going back to pre-pandemic times. A market outlook published by Grandview Research stated that “the global virtual clinical trials market size was valued at USD 8.3 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 5.7% from 2023 to 2030. The market is majorly driven by a rise in R&D activities, increasing healthcare digitization, as well as the adoption of telehealth. Besides, technological advancements, alliances between clinical research organizations, pharmaceutical, and biotechnology companies as well as supportive government initiatives are anticipated to drive the market.”8 As the benefits of digital technology become more apparent, it is likely that its use will become more widespread across a variety of therapeutic areas. However, it is important to address the challenges and risks associated with the use of digital technology to ensure its effectiveness, compliance with regulatory standards, and its adequate use for a particular clinical research project. The choice of technology should consider the expertise in the clinical area, the deep understanding of protocol and study design combined with cutting edge adaptive technology that can easily scale and cater for very specific protocol needs.
Discussing your project with a trusted technology partner such as Huma can help you get the support and information needed to understand the scope of your digital study while leveraging clinical and scientific expertise acquired over more than 10 years.
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