The COVID-19 pandemic has forced sponsors/CROs and regulators alike to adapt to the effects on clinical trials, by incorporating virtual and remote data collection methods into ongoing and new studies. Have the implementations been successful, and will they be continued?
Digital innovation has been much discussed within the life sciences industry in the past two years, given the benefits of patient-centric trials and enhanced enrollment, but adoption has been relatively slow. The COVID-19 pandemic has triggered a rapid shift toward adopting technologies that enable clinical trials to function remotely, minimizing the risk of infection for everyone involved. This contributed to mitigate the initial disruption to clinical development programs, which saw a 30% drop in new trial starts globally in April 2020 compared to last year, combined with a 70% drop in the average number of new patients entering trials per site.1
There was a 70% drop in the average number of new patients entering trials per site in April 2020.
In a recent roundtable, Joel Haspel, Senior Vice President of Strategy, Life Sciences, Clarivate; Dr. Scott Gottlieb, formerly the 23rd commissioner of the US Food and Drug Administration (FDA); and Shwen Gwee, Vice President and Head of Global Digital Strategy at Bristol Myers Squibb discussed the use and success of digital approaches and tools in clinical trials and the regulatory frameworks guiding them.
Current status of digital technologies in clinical trials
Benefits of digital innovation include the collection of real-world evidence, insights from continuous patient monitoring and better recruitment and retention due to greater patient-centricity. In addition, enabling virtual or remote data collection provides opportunities to expand trials to a larger, more diverse population. It’s no surprise then that clinical trials have begun to tap into the capabilities of digital technologies.
Over the last nine years, 13,000 trials related to digital health have been identified, including virtual and hybrid trials, as well as trials with a digital health intervention. The number has gone up by 40% in the last five years, and based on recent estimates 70% of clinical trials will incorporate digital sensors by 2025.2
13,000 digital health trials over the last 9 years referenced the use of digital health.
Although there has been considerable experimentation over the last couple of decades to digitize clinical trials, what has really driven adoption is the ubiquity of standardized devices and access to digital platforms. For example, as devices such as the Apple Watch are cleared by the FDA to collect data in a clinically validated manner, they become more useful and accessible to clinical trials. This means that we now have the opportunity to leverage phones and wearables that are already being used by patients to collect data. However, it is a persistent challenge to integrate these new technologies with the legacy platforms and solutions used to run and manage a clinical trial.
Regulatory support of digital technologies
In light of COVID-19, regulatory bodies have granted greater flexibility relating to the use of technology. Early in 2020, these agencies issued guidance on telehealth, remote technology for clinical assessments and remote site monitoring — for existing trials as they navigated COVID-related disruptions and specifically for COVID-19 trials.3-5 One key consideration is balancing flexibility related to potential protocol deviations against patient safety and data integrity.
To enable this, more decentralized tools were implemented and approved for implementation. This is likely to be a secular shift, driven partly by COVID-19 and partly by the resulting cultural changes. Efforts to decentralize clinical trials and collect data outside of the traditional site setting (in the community, at a point of care close to the patients or even in the home) will continue.
What we’re observing is essentially an acceleration of trends that were already underway. Patients have become more accustomed to receiving care and providers are more accustomed to delivering care via telehealth, and this capability will be incorporated more into clinical trials. In addition, many digital tools could act as substitutes for site-based assessments. However, work will be required to validate more of these tools to the satisfaction of regulators so that they can be assimilated into trials in the same rigorous fashion as site-based assessments.
We’re observing an acceleration of trends that were already underway.
The FDA has established a framework and policies6 over the last several years not only to help validate digital tools but also to drive their adoption. Strategies have included the creation of a digital health team and launching a pre-certification program for digital health tools, both as standalone tools and to be used in clinical trials. In addition, it has clearly outlined regulatory paths to validate digital technologies.
Defining digital innovation
Digital innovation could be considered the successful implementation of a creative solution using a digital modality for a traditional problem — either incrementally or in a disruptive way. One opportunity is supplanting current approaches with digital tools to collect new types of data or data that were previously difficult to collect. We can collect data that is clinically relevant to patients and available on a more continuous basis, providing better context for the patient experience. For example, physical performance outcomes are often measured episodically (e.g., 6-minute walk test for COPD patients) and could be affected by a number of factors: mood, motivation, fatigue, etc. Continuously measuring digital mobility biomarkers during a patient’s normal activities more closely reflects the efficacy of a given therapy.
Patients are also driving innovation in this space. Habits in seeking care and how they approach care settings are changing. There is less desire to enter academic centers for trial follow-up, and protocols will need to adapt to that demand.
The greater adoption of telehealth has also broken down walls to the acceptance of digital tools in trials and healthcare. Telehealth is an example of something that is not innovative in and of itself – but is an enabler of innovative solutions. Most of these digital tools have existed for years, but can now be leveraged in new ways for data collection without disrupting patients’ lives. Opportunities for innovation exist in how we make sense of that data: artificial intelligence, machine learning and other tools to help separate the signal from the noise. But we’re not there yet – many digital tools still require some human interaction.
Advancing digital health through collaboration
To reach digital transformation, industry players need to collaborate and communicate often to keep abreast with this rapidly changing environment. The onus (and expense) of validating each digital device and platform for use in clinical trials falls on the sponsor. Sponsors have the opportunity to pool resources for tools that can be used in a repetitive fashion. We see precedence for this — collaboration for biomarker assays reduced duplicative efforts and accelerated the use of biomarkers in clinical trials. Furthermore, this work does not need to be limited to pharma only. In fact, pilot partnerships between pharma and big tech companies are filling some of the gaps on both sides.
To reach digital transformation, collaboration is required.
There is also power in numbers. A digital health industry consortium, for example, could stimulate change within the regulatory environment — by pioneering approaches to reliably measure the effectiveness of digital tools in a pre-competitive environment, both as stand-alone solutions and in the context of clinical development challenging the system and creating the need for new guidance and regulations
COVID-19 has accelerated digital innovation within clinical trials, and we have the opportunity to continue the momentum and benefit from more efficient trials and better patient outcomes.
Ready to understand the future of digital health? This discussion and successful implementation of digital tools in clinical trials span all aspects of development. Cortellis has intelligence and analysis solutions to inform every step of the way: Cortellis Digital Health Intelligence™, Clinical Regulatory Intelligence™ and Clinical Trials Intelligence™.
- Cortellis Clinical Trials Intelligence, Cortellis Digital Health Intelligence, Medidata. COVID-19 and Clinical Trials: The Medidata Perspective
- Jansen Y, Thornton G. Wearables & Big Data In Clinical Trials — Where Do We Stand? Clinical Leader. February 25, 2020. Available at https://www.clinicalleader.com/doc/wearables-big-data-in-clinical-trials-where-do-we-stand-0001
- Cortellis Regulatory Intelligence, FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency. Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency
- Cortellis Regulatory Intelligence, Managing clinical trials during Coronavirus (COVID-19). Available at https://www.gov.uk/guidance/managing-clinical-trials-during-coronavirus-covid-19
- Guidance on the Management of Clinical Trials During the COVID-19 (Coronavirus) Pandemic. Available at https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf
- FDA Digital Health Innovation Action Plan. Available at https://www.fda.gov/media/106331/download