Driving innovation in clinical trials and digital health: Impressions from SCOPE 2021

Celebrating its 12th successful conference, SCOPE Summit 2021 took place from March 2-4, 2021. Like most events during the COVID-19 pandemic, this year’s summit was fully virtual. During these unprecedented times, the work that the clinical research community does is more important than ever, and requires collaboration and innovation. Antidote’s Dave Mauro, Executive Vice President of Business Development, and Nathaniel Celentano, Business Development Director, attended SCOPE and shared key takeaways. 

What major themes jumped out to you at SCOPE this year?

One of the biggest themes of the conference this year was diversity, equity, and inclusion in study populations. These themes are directly related to access, and on that front, we saw a lot of talk about optimizing access to clinical trials through decentralized initiatives, which is both helpful in making trial access more equitable and also ensuring safety during a pandemic. Various conference attendees spoke about identifying and removing barriers to clinical trial participation, with a specific focus on socioeconomic barriers, such as reimbursement, travel logistics, and minimizing patient burden in other ways, such as understanding that not everyone can take a day off of work to go to a study site. 

One of the biggest concerns in the industry is that sponsors are not doing enough to drive diversity, particularly around communities of color and those impacted disproportionately by COVID-19. This is on par with a recent whitepaper Antidote published about decentralizing research and how reducing patient burden improves trial diversity. Sessions from SCOPE 2021 echoed the thesis of that whitepaper: decentralized trials will help diversify study populations. 

Sponsors are soliciting input from patient advisory councils to ensure messaging is clear. They want to help remove the stigma around clinical trials and break down the preconceived notions many have of being a “lab rat.” As it should, the voice of the patient received a lot of attention this year. Keeping patients and participants at the heart of trials is critical.

Of course, at the top of the docket was also COVID-19, which has forced companies to rapidly shift toward a decentralized trial model. Many presentations focused on how companies are adapting. There was diverse commentary on how some things may have changed the clinical trials landscape permanently. For example, decentralizing studies and forward-thinking about site locations that take political and actual COVID-19 impact into account. 

On the operations side, enrollment predictability was a key theme. How can sponsors create better tracking and targeting algorithms to monitor the progress of each recruitment campaign? There was discussion about flexible and adaptive tracking to the current environment as opposed to static tracking set at the beginning of the campaign and adjusted only when things go sideways. 

What innovation trends did you pick up on? 

With decentralized trials, innovation trends and models abound. Enrollment forecasting tools seem to be getting more sophisticated. AbbVie shared a proprietary approach, which was built with logical algorithms to improve predictability.

While there is a consensus that virtual trials are here to stay, there seems to be a lack of agreement as to the readiness of sponsors to support decentralized trials. 

Technology and the learning curves that study teams and patients face when trying to use said technology can be a tall order. Companies are building integration platforms to pull together data from many sources, which allows for a greater ability to monitor decentralized trials. Alas, while wearables have made their way into the clinical trials market, there is still a long way to go for more universal use. 

COVID-19 has been dominating the clinical ops discussion for the past year. From what you heard about at SCOPE, how is the industry adapting?

There has been an explosion of telemedicine and eConsent technology. Removing a site visit altogether, especially for conditions that put patients at high risk due to COVID-19, is becoming extremely prevalent. In-home visits are also becoming prominent.

One big challenge sponsors have faced during the pandemic is assessing risk and mitigation strategies. Surveillance and monitoring have become even bigger priorities.

Flexibility remains the gold standard mentality to continuing trials through COVID-19 fluctuations. Patient safety is the mantra and guiding principle. Many sponsors are building registries that keep patients engaged until a study is unpaused or starts back up again. 

The issue of diversity and clinical trial participation is critically important, and COVID has amplified this. Better treatments and potential cures will continue to be elusive for some segments of the population if trial populations don’t reflect the real world.