When you have a chronic condition like Chronic Obstructive Pulmonary Disease (COPD), arthritis, heart disease, and diabetes, for example, your days are challenging. You may find it hard to walk, breathe, or simply make a cup of tea. You may also be on a cocktail of medications, and be suffering from a number of comorbidities. So, when your doctor offers you the opportunity to join a clinical trial, you experience a glimmer of hope that some magic cure may help alleviate your suffering. But, when your doctor shares that the principal investigator is 90 minutes across town, your hopes are dashed. Yet another recruitment candidate lost.
Some 70% of potential participants for a clinical trial live over two hours away from their nearest study center. And now, with COVID-19, the thought of a major ‘masked-up’ commute to an investigational site is a huge barrier to enrollment.
So, here we are as an industry with a huge pipeline of innovative new therapies ready for trials, but struggling to recruit a significant number of patients to prove out efficacy and safety for submission and market launch. If only there was a better way.
Of course, there are better ways. In recent years, the industry has been adopting new technology to advance the digital transformation of clinical trials. The concept of decentralized trials with “hybrid” (in-person and remote patient visits) or fully-remote subject visits has just been catapulted beyond small satellite innovation teams to becoming the new norm.
I recently had the pleasure of presenting alongside fellow colleagues from ActiGraph and Parexel to the Clinical Research Association of Canada, to share our experiences on the journey to this new norm. Whilst Canada is the second largest country in the world by land mass, most of the population live in or near the six major cities. Commuting 60 minutes across Toronto to a study site may well be a challenge, but a four-hour trek to Ottawa is clearly prohibitive. With over 20 years’ experience in the actigraphy space, ActiGraph know the great opportunity that sensors can deliver to patients and research. Likewise, Parexel, as a major global CRO, has executed many decentralized trials and understand the patient, site, and sponsor perspectives, as well as how to work with global regulators to ensure success.
Wearables, medical sensors, mobile apps, eConsent, smart pills, smart home diagnostics, voice agents, telehealth are just some of the many technologies we can leverage to enable hybrid or fully-remote visits in decentralized trials. Simply enabling three visits to be home based (with some augmented by a home nurse visit) out of a total of six could be the difference between a potential recruit becoming an enrolled subject or not.
With a decentralized approach, we not only have the potential to reduce the travel burden on the subject, leading to increased population pools and lower attrition, but we acquire significantly more quantifiable, less subjective data, compared to traditional site-centric trials. Decentralized trials are not only limited to chronic conditions. For example, in dermatology, clear real-world evidence can be gathered using actigraphy devices to measure scratching episodes, flare-ups, as well as using photo evidence to show rash intensity.
We now see a convergence of these new approaches happening, and groups are emerging as major industry consortiums to propel this momentum. One such notable organization is DiME (Digital Medicine Society) who have just released a reference document for open review. Decentralized trials are posed to move mainstream with a wealth of sensors and wearables to validate and adopt, multi-channel mechanisms to engage with patients (e.g., mobile apps, digital assistants, and voice), and well-established technologies to connect, enable, and analyse resultant data to gain insights and identify novel signals, previously hidden by traditional methods.
Fig 1: The Playbook: Digital Clinical Measures
The one missing piece of the shift to decentralized trials has been adoption of telehealth and video-based clinical visits. Whilst the technology has existed, two key barriers precluded its adoption: state/regulatory support and end -user (physician) acceptance. COVID-19 has broken down these barriers, almost overnight in the US, triggering mass relaxation of regulatory hurdles, and likewise immediate realization by the medical community that video can work, and in many cases, is better than face-to-face interactions.
Decentralized trials will change clinical research forever, driving patient centricity, richer real-world data, and faster development of life enhancing therapies. To learn more, read this research report, regarding the use of virtual components in clinical trials.