By Maria Palombini, director, healthcare and life sciences global practice lead, IEEE Standards Association (SA)
The clinical trials industry is compelled to embrace digital transformation in its approach to patient recruitment and engagement, study design protocols, and overall trial management. On a regular basis, many shock-and-awe numbers are publicized as to the rising cost of bringing a new drug to market, the declining rates of enrollment and patient retention, and the extended length of overall trials. Although these numbers often stir up emotions and debate, they are often undervalued as a symptom of the main problem: Clinical trials are not modernizing fast enough due, in part, to lagging global standards.
Embracing DCTs And Digital Components
As it stands, there are not enough clinical trials incorporating a decentralized component.
According to Global Data Analysis, a record number of approximately 1,300 trials with a decentralized and/or virtual component will have likely initiated in 2022, representing a 20% increase in such trials from 2021. And according to RSM, there are a little more than 16,000 active industry-funded and interventional clinical trial studies in 2022. Observing these two data points independently, there seems to be no real cause for alarm. However, together they paint a very different picture. Considering both data points together, only 8% of all current studies are utilizing a decentralized component. If true, how modernized can today’s clinical trials be?
Integrating elements and/or the process of decentralized clinical trials (DCT) compels clinical operations to become more digitalized. Digitalization is much more than electronic data capture and electronic data management systems. Digitalizing the entire process enables the use of the many exciting technologies in the digital health toolkit, including artificial intelligence (AI), machine learning (ML), blockchain/distributed ledger technologies (DLT), digital therapeutics, wearables, the Internet of Things (IoTs), biosensors, and many more. These following digital technologies present the opportunity to optimize the clinical trial management process from study design through review:
- Wearables and sensors minimize, if not eliminate, the need for patients to visit sites. Their continuous monitoring capability provides troves of data that can be further mined and used to improve clinical study design, protocols, recruitment, and more.
- Digital therapeutics in the form of a smartphone app can be used to encourage patient adherence (i.e., medication reminders) or make participant feedback collections for eCOAs (electronic clinical outcome assessments) more efficient and effective.
- Software as a Medical Device (SaMD) includes fixed or adaptive algorithms used for multiple purposes, including prescreening, screening, adjunctive clinical diagnosis, clinical diagnosis, medical monitoring for adverse events, and more.
- AI/ML can be used throughout most steps of DCTs or modernized trials with the ability to predict patient retention rates, better analyze and implement participant feedback to reflect the patient’s perspective, better identify and target patient populations for recruitment, filter unstructured data from multiple patient record sources to gather insights, and more.
However, these technologies are relatively new to a legacy process, which begs the inevitable question: Can they be trusted? How are they validated? Will they work the way they are intended? There are many technical and ethical considerations that clinical trial management teams need to understand and negotiate when applying these technologies to their processes while asking patients to use and trust them. This conundrum of trust in digital technologies can be the very obstacle to deciding whether a component or the entire trial will be decentralized.
Patients Are Ready, But Are Clinicians?
While trust can be the cornerstone of clinicians’ concerns, patients are seemingly ready to embrace more digital components. According to a survey conducted by Deloitte, 92% of clinical trial patients believe that improving experiences (such as through innovative technologies) should be a top priority for the healthcare industry. Patients are embracing digitalization quickly, and a great example is the growing wearables market:
- The number of connected wearable devices worldwide has more than doubled in the space of three years, increasing from 325 million in 2016 to 722 million in 2019. The number of devices is forecast to reach more than 1 billion by 2022, according to Statista.com.
- There were 52,406 healthcare and medical apps available on the Apple App Store, according to Statista.com.
- A single patient generates nearly 80 megabytes of data each year in imaging and EMR data, according to 2017 estimates by Frontiers and Forbes.com, and that does not include other health data from wearables and the like.
At this rate of use, it can be argued that patients are ready for it. The growing use of digital technologies such as wearables, digital therapeutics, and other biosensors by patients provide benefits that were never available before to patients to participate in their wellness/health process. These technologies provide benefits to patients in different ways:
- Convenience: These remote tools enable patients to connect with clinical site investigators, which reduces or sometimes eliminates the burden of traveling to sites on a regular basis.
- “Trackable” awareness: Patients used to measure their response in clinical trials by physical changes to their daily routine without any real confidence or metrics to support it. Digital tools provide insight on how patients are performing with measurements and units courtesy of user-friendly tool dashboards.
- More data, more insight: Patients can use more data and integrate it into their overall health and wellness profile for a potentially longer life span.
Yet, scientists and clinicians are not engineers or technical gurus. Therefore, how do they effectively evaluate what and which technologies should be used and trusted? The answer is not so simple. Just as with any new technology integrated into an ecosystem, time is needed to develop confidence as the application continues to be refined and the technology continues to evolve. The process will take some time to learn from trial and error. However, it also will require communities of multidisciplinary experts including clinical professionals and patients to get involved with development of global industry technical standards to address these uncertainties in the application and/or technology itself.
Looking To Global Technical Standards For Guidance
Some clinicians will look to policy and regulators for guidance on what, how, and when digital health tools can be integrated into clinical trials. Others will look at global standards development organizations (SDOs) that are bringing together a community of experts to collaborate and develop solutions via open technical and data standards.
Looking at the world of health sensors and wearable devices, there has been more development in global technical standards to mitigate concerns of data transfer and portability (HL7/FIHR), communicability (IEEE 11073™), and open sharing of mobile health (mhealth) data (IEEE 1752.1™) that enable a more holistic approach to the use of wearables and biosensors across the healthcare ecosystem. However, more development is still needed in the space of cybersecurity, patient privacy, data governance, validating algorithms, data integration, and more.
Looking beyond sensors and wearables, there are many similar technical and ethical questions on the use of ML, AI, digital therapeutics, and others. The need for standards is critical to address the many ethical considerations regarding patient data governance, a secure data journey from device to cloud, algorithmic bias and fairness, patient privacy, and more. Building consensus and development of these global standards requires involvement from all stakeholders — clinical professionals, technologists, regulators, and patients and their representatives.
But why are technical standards so important? On any given day, internet users trust that a mobile device will connect to Wi-Fi. The global technical standard (IEEE 802.11™) helps enable seamless connectivity anywhere in the world. Wouldn’t it be just as great to have the same approach when digital technology is integrated into the clinical research process? It would leave little reason to question whether the technology worked in such a way that it can be validated, protect the privacy of the patient, and is interoperable with the clinical trial data management system. We are just not there yet.
About The Author:
Maria Palombini is the director, healthcare and life sciences global practice lead at the IEEE Standards Association (SA) . She is also the staff liaison to various IEEE global incubator projects for DCTs, sustainable telehealth systems, digital mental health, and more.