What clinical trials of the future might look like

It is the year 2035. Wearable technology has advanced rapidly beyond its early iterations. Instead of smartwatches, goggles or haptic gloves, "wearables" are now unobtrusively integrated into our clothing and accessories. Your shirt has embedded sensors to track your heart and lung function, your belt tracks balance and communicates with your shoes to measure walking performance.  Long gone are the old-world concerns about connecting or charging your tech gear, replaced by low power devices that harness your body’s heat and motion to maintain their charge. 

Fatta Nahab, Head of Movement Disorders Science Unit, Biogen Digital Health

These different components are capable of seamlessly working together and sharing their meaningful data with you and anyone else you allow. In this hypothetical scenario, you are not engaged in a video game — you are a participant in a clinical trial. The wearable devices you are donning passively monitor your heart rate, body temperature, sleep patterns and more. These metrics are aggregated in a private, secure portal with other participants' data, and artificially intelligent algorithms discern trends, identify anomalies, and distil the most salient information. This data then helps researchers — and ultimately health care providers — hone new treatments and create personalized care plans for each of their patients.

This futuristic scenario is still speculative, but it is not exactly that far off a dream. Today, digital technologies are increasingly playing a critical role in health care, and clinical research in particular.

At their core clinical trials help test the safety and efficacy of new treatments. For trial participants, the generous contribution of their bodies and time are intended to accelerate new treatments and give back to their communities...and in the best-case scenario to transform health. In comparison to this ideal, the traditional way of conducting clinical trials is far from perfect. First, there are the intertwined issues of access and equity. From a patient perspective, even being aware of an ongoing trial they may be eligible for is a challenge. It's often a "right place, right time, right doctor" scenario. Should such an opportunity arise, often the logistical demands of multiple visits requiring an extensive time commitment of the participant and occasionally a caregiver make it difficult for many to commit. The use of digital tools holds the promise of addressing these access and equity challenges that frequently slow the pace of recruitment and limit the understanding of how a new therapy impacts members of underserved communities. We have seen this play out in a pronounced way during the Covid-19 pandemic: immunocompromised people, including many seniors, have been understandably hesitant to travel to clinics in person let alone participate in a clinical trial.

Another key limitation in current clinical trials is the issue of reliability. No individual feels exactly the same within a day or over time, and yet most studies evaluate how the patient feels during infrequent and relatively short visits that take place in the artificial research environment which does not reflect their day-to-day reality. Individuals suffering from neurological disorders such as Parkinson’s disease experience large fluctuations in their symptoms. Current trials do their best to assess this symptom variability, but the demands on patients to communicate all their symptoms fully and objectively or for the clinical investigator to collect such information during the confines of a study visit are immense. Real-world experience provides many advantages for data. These advantages provide a clearer understanding of whether a treatment can address a fundamental need – to remain independent and maintain quality of life.

There is one final issue: Today, it is far too common that trial participants with vastly different circumstances are lumped into one homogenous group. Researchers go to great lengths to ensure that control groups that do not receive the treatment being studied and the experimental group that does are similar. Current efforts to create these equivalent groups are fairly simplistic, focusing on the "average" ages and gender/sex distributions while ignoring important factors like the presence or absence of individual symptoms within the groups. Researchers also typically rely on vague concepts of disease severity when studying, say, Alzheimer's or Parkinson's.

As digital solutions become more integrated into clinical trials, it will be possible to create detailed profiles of each patient and randomize those individuals into a trial who are more closely matched to enable more reliable comparisons. This can also lead to more nuanced insights about how new treatments are likely to help individuals rather instead of the ‘average’ group.

When it comes to Parkinson's Disease¹, one of the most prevalent neurodegenerative diseases in the U.S., the ability to conduct clinical trials in real-world settings and remotely monitor symptom progression can lead to life-changing discoveries.

In Parkinson's disease, digital devices can monitor physical data like tremor, balance, sleep patterns, mood, heart and gut function, and cognitive capabilities — symptoms that contribute to disability yet are difficult to measure with traditional trial designs.

At Biogen Digital Health, our goal is to make these ambitious possibilities into realities. I am happy to say that we are already working toward these goals. Currently, we are involved in a large-scale study evaluating a new therapy that aims to slow or prevent the progression of Parkinson's. Throughout the trial, BDH is supporting digital efforts, including the use of wearables, smartphones, and apps to monitor participants' progress.

The implications for digital solutions in this capacity transcend the research use case. In the future, digital technologies will help us forge an entire ecosystem of support, from trial to treatment. That translates to better context for researchers and clinicians, better and more specific guidance for health care professionals and, better outcomes and individualized care for patients.