Clinical Researcher—January 2021 (Volume 35, Issue 1)

DATA-TECH CONNECT

Henry Levy

In response to COVID-19, the clinical research enterprise has made Herculean efforts to minimize disruption and accelerate clinical development in the past year. From simpler trial designs and faster protocol development to decentralized trials that digitize specific trial processes, there have been countless examples of life sciences companies and health authorities coming together to innovate and collaborate more efficiently.

We expect to see acceleration across clinical development as more companies shift to modern, digital applications over manual, paper-based processes in 2021. We’re already starting to see this happen with the growing adoption of solutions that enable virtual visits. The efforts are streamlining trial execution and lowering the patient burden of participating in studies.

Looking ahead, transformation in the clinical space won’t slow down. Trials will continue to advance toward paperless, patient-centric approaches—streamlining processes for sites and expanding a study’s reach to new patient populations. Companies will modernize data management to meet new regulations. Real-world evidence will make contributions to clinical studies and improve the development of products. Here are three predictions about changes to watch for in the industry in 2021 and beyond.

Paperless, Patient-Centric Trials Will Drive More Effective Clinical Development

Getting participants to finish a clinical trial has never been easy due to the heavy burden placed on them. In 2019, dropout rates rose to 19% in late-stage studies globally from 15% in 2012,{1} and COVID-19 disruptions and restrictions have only deepened the need for change as the industry looks to end its reliance on paper.

In response to these compounding factors, paperless, patient-centric trials will be a top priority for life sciences companies to reduce the patient burden, provide more access to trials, and modernize studies. Whether through an electronic consent process, remote data collection, or virtual visits made possible in a decentralized trial model, there are numerous ways we’ll see sponsors, contract research organizations (CROs), and sites make it easier for patients to participate in trials while improving stakeholder collaboration over the course of a study.

The digitization of trials will also help enhance the diversity of patients participating in them by expanding the reach and access of studies. Sponsors can help spearhead this effort toward greater diversity by specifically seeking out research sites in underrepresented geographies, while CROs can invest in more support for investigators in areas with minority populations.

By giving patients an easier way to participate in clinical trials and showing them their commitment to diversity in the coming years, life sciences companies will improve study outcomes and drive more effective clinical development.

Clinical Data Management Modernization Will Accelerate to Meet New Regulations

Increasing regulations from the U.S. Food and Drug Administration (FDA)—and more recently, the European Union Medical Device Regulation—have created a new sense of urgency for medical technology companies to improve data collection and analysis. Manual processes and legacy systems are no longer going to cut it if companies want to ensure compliance, reduce risk, and allow for innovation moving forward.

As a result, we expect to see the industry shift toward more connected and transparent ways of managing its various forms of clinical data next year. For example, more robust, modern infrastructures will help companies track, analyze, and share much larger and diverse datasets stemming from more complex studies—both pre- and post-market.

In this new world, where data collection is never going to stop and regulations will continue to evolve rapidly, the companies that invest in more modern approaches to clinical data management will have the agility they need to adapt for the future.

Real-World Evidence Will See Real-World Application

While the industry has been talking about using real-world data in clinical trials for more than a decade, it wasn’t until within this past year—with the urgency and rapid digitization brought on by COVID-19—that companies finally began viewing it as an essential, rather than as a merely nice-to-have, capability.

Computers, mobile devices, wearables, and other biosensors hold a wealth of information about patients. From sleep quality and heart rate to step count and calories consumed, there are various lifestyle-related datapoints that study administrators can now use to supplement the data they’re collecting in a controlled setting.

With the FDA and other regulators now starting to accept this type of real-world data, we see an exciting opportunity to improve product development, health decisions, and diagnostics related to all therapeutic areas. While these are certainly still early days for the “new normal,” the infrastructure, regulatory environment, and technology have all reached a place where real-world data can scale and consistently contribute to clinical development.

The Industry Accelerates Toward Modern, Connected Clinical Research

The impact of COVID-19 was felt across the industry. More than 100 companies reported disruptions of their clinical trials,{2} and more than 1,900 studies have been affected.{3} The industry accelerated modernization efforts to enable virtual visits, remote monitoring, digital ways of collecting data, and more to ensure trials remained on track and to start new trials fast.

Sponsors, CROs, and sites are entering an era in which clinical development will be much more connected, digital, and streamlined. Clinical teams will be able to work more efficiently and faster, and patients will have more access to, and choices for participating in, trials. While the challenges experienced in 2020 will be unforgettable, the future for clinical trials is brighter than ever.

References

1. Tufts CSDD Impact Report. 2020. Tufts Center for the Study of Drug Development. https://static1.squarespace.com/static/5a9eb0c8e2ccd1158288d8dc/t/5e303c3dd4520c015cb8a4b1/1580219453985/JanFeb2020_CropSummary.JPG
2. BioPharma Dive. 2020. A Guide to Clinical Trials Disrupted by the Coronavirus Pandemic. https://www.biopharmadive.com/news/coronavirus-clinical-trial-disruption-biotech-pharma/574609/
3. Carlisle BG. 2020. Clinical Trials Stopped by COVID-19. The Grey Literature. https://covid19.bgcarlisle.com/

Henry Levy (henry.levy@veeva.com) is general manager for Vault CDMS, site, and patient solutions with Veeva Systems, president of the industry standards groups Align Biopharma and Align Clinical CRO, and a board member of the Alliance for Clinical Research Excellence and Safety.