The Future of Clinical Trials Series: Part II

If 2019 was the year of personalized medicine, 2020 was the year of decentralized trials but there’s still significant progress to achieve. Industrywide, the decentralized approach to clinical trials is philosophically embraced for all its advantages but operationalizing it – particularly mid-flight on studies – requires a commitment to overcoming fear of change. The model’s inherent flexibility will be instrumental to calming any concerns and will drive widespread adoption through 2021.

Greater awareness of social injustices will ensure diversity is no longer an afterthought.

Jena Daniels, Director of Research and Head of PAC, Medable
 
As we continue to open our eyes to social injustices across this country, more pharmaceutical companies will engage in real conversation about equality and have another important reason to embrace a decentralized approach to trials. But this is just the start. From New Year’s Day onward, trial sponsors will not only embrace DCTs to expand access but also involve more people of color in protocol development. Diversity will be first-order priority at the beginning rather than reverse-engineering racial equality into the trial design as a rescue mission.

Study teams, too, will become more diverse so all demographics have better representation. They will bring vital insight into cultural and communications differences that can impact trial design and outcomes. Already, people of color are less inclined to take an approved COVID vaccine even as they are a more vulnerable group, yet this could be overcome with better communication and education.

Expect to see diversity increasingly baked into study protocol design and product development over the next year and beyond. And it will extend beyond people of color to include different genders and ages. We will see patients from all backgrounds involved in the study process from the start. Medable’s Patient Advocacy Council (PAC) has patients ranging in age from 20 to mid-70s, a mix of female and male members, and is expanding to add minorities in early 2021. The PAC informs product development and trial design – not on the back end, but at the beginning when they can make the biggest impact.


Patients will be at the center of every aspect of clinical research.
Rasmus Hogreffe, VP of Decentralized Trial Innovation, Medable
 
The recent expansion of DCTs will have the unintended effect of holding a mirror in front of the life sciences industry that reflects the longstanding lack of focus on patients. In 2021, several factors will inspire companies to make substantive changes to how they operate to put patients at the center of everything they do.

For instance, research sites will start to see the impact that a decentralized approach has on patient care and embrace, rather than fear it. DCTs will allow patients to stay safely in their homes and still have physician-monitored access to potentially life-altering new therapies. And, because patients’ health is surveilled continuously using wearables, electronic diaries, virtual check-ins, and other tools, they receive premier care. Sites can respond in real time and engage directly with patients more often.

In the last decade, the life sciences industry was distracted by a turbulent environment where blockbusters were replaced by biotech innovators, globalization became the norm, and regulatory change was the only constant. New technologies have helped companies manage these changes but social injustices, growth in personalized medicine, and a global pandemic will change the conversation in 2021 back on patients.

Building patient relationships requires sponsors, sites, regulators, and technology partners to break down the silos that have hindered collaboration. We do not need a wrecking ball to do this, either – just trust and transparency. Patient advocacy groups are key to building bridges. And, advanced technology platforms that enable transparency across stakeholders and that are flexible too.

Digital biomarkers could expose ‘simmering’ symptoms before they turn serious.
Ingrid Oakley-Girvan, Ph.D., MPH, SVP of Research and Strategy, Medable
 
Tech-minded epidemiologists are working to crack the code of digital biomarkers as they could signal – early on – important changes in the trajectory of a disease. Researchers are now able to capture quality data, on a longitudinal scale, and harness that data across groups of patients to establish accurate markers. The fall-out of COVID-19 has accelerated this effort as more companies take a decentralized approach to clinical trials and leverage remote data capture.

While the digital biomarkers that can be captured remotely are often constrained by cost and logistics, there is rich data that can be collected reliably with modern technology. For instance, a daily video that shows progressive changes to a Parkinson’s patient’s shuffle, a wearable device that measures hand tremors continuously, and a digital sleep monitor that tracks REM sleep cycles all inject new factors into the research equation to help determine accurate digital signatures. As critical, decentralized clinical trial (DCT) platforms enable researchers to collect higher quality data from patients in their natural environment when they are most relaxed, and eliminating the “white coat effect.”

As DCT adoption increases, science will start to be able to identify the early “simmering” symptoms that could turn into an adverse event later in the trial. Since the development of symptoms has the potential to jeopardize patient safety, instill fear and panic – patients could drop out of a trial prematurely. Identify these early, however, and the care team may be able to rapidly mitigate symptoms, prevent psychological harm, and avoid losing patient participation – especially if the incident was not caused by the investigative drug but rather, external factors such as dehydration or lack of sleep.

In 2021, the momentum of DCTs and virtual technologies will allow clinicians and researchers to better identify digital biomarkers to help improve care and maintain the integrity of vital clinical trials. It will be the beginning of truly proactive patient care that is mindful of individual situations – the ultimate in long-promised personalized medicine and patient-centricity.

Greater access will drive radical improvements in trial efficiency and effectiveness.
Dr. Michelle Longmire, CEO and co-founder, Medable
 
As an unimagined consequence of the pandemic, we are starting to see the impact that decentralization will have on trials – making them both more efficient and effective.
 
This past year, the decentralized model provided a vital stopgap to overcome the halt of clinical trials for thousands of shut-in patients and trial staff. What served as a band-aid in the short term quickly developed into a recognition that decentralized approaches can deliver a variety of benefits to sponsors, CROs, sites, and patients. We saw faster enrollments and greater retention for patients participating from home. We saw more and higher quality, real-world data. We saw more efficient processes and a dramatically improved patient experience. We saw the resistance to digital and mobile technologies melt away, as televisits and remote screening and enrollment made participation easier for more patients from more places.
 
As the life sciences industry continues to march forward with its adoption of a decentralized model, it is critical to continue evolving the technology. Companies simply will not go back to pre-pandemic ways. As the industry continues to learn and innovate, the domino effect will drive 50-70% increases in trial access and efficiency – ultimately leading to more effective therapies for more people around the world.