Trendspotting: Hybrid and Decentralized Clinical Trials, Patient-Centricity, and Increased Remote Patient Monitoring

We spoke with clinical research leaders about their expectations for the coming year. We heard predictions that digital methods and tools will become the priority as sponsors take the lead and encourage shifts toward hybrid and decentralized trials (DCTs). “With the rapid maturation of digital technologies and increasing comfort level with digital tools by patients and doctors, sponsors will adopt a digital-first mindset for every trial. Digital technologies will be considered from the start rather than force-fitting them into a trial mid-way, ensuring a more successful trial design overall,” said Joel Morse of Curavit.

As DCTs become more prevalent, brick-and-mortar sites are expected to embrace flexibility and patient-centricity to improve retention. “The site will [place an] emphasis on the notion of heightened flexibility for the participant. We will see further adoption of innovative tools that offer options for receiving care and completing trial activity while keeping the site in control and enabling them to maintain an even increase in efficiency,” said Jim Murphy of Greenphire.

Eric Hodgins of IQVIA predicts an uptick in in-person visits as more patients integrate into a “post-COVID” society, but not without significant adjustments to trial design. He said, “With in-person visits increasing again, we will see many trial sponsors take a more thoughtful approach to how studies are designed to drive efficiency for both sites and patients and use greater data interoperability. This will come [from] taking a ‘science up’ approach built on a foundation of standards and regulatory guidance.”

Industry leaders anticipate that many clinical sites will be overhauled as researchers seek to reach new and diverse communities. “Nearly any trial site—including those community-based sites often closer to underserved communities—can be well-equipped to handle increasingly complex research, making them attractive alternatives. As a result, we’ll see life science organizations increasingly eschewing the same-old trial sites to bring more research into more diverse communities,” said Liz Beatty of Inato.

In response to the threat of an economic downturn, companies will rely heavily on remote patient monitoring and wearable devices to stretch their budgets. Ed Ikeguchi of AiCure said, “Sponsors will likely streamline the tools and emphasize technology patients already own—like smartphones—to gather key data points. With many facing clinical talent shortages, services that help ease the site’s technology burden will be critical to maintaining efficiency and high-quality data capture.” Ben Casavant of Tasso emphasized the benefits of a financially lean and patient-centered approach. He said, “A more patient-centric experience will accelerate the time to market for new drugs, devices, and therapies due to the higher-quality data, better participant compliance, more accurate representation, and lower overall study costs.”

Research organizations will also employ technology and real-world evidence to get products to market faster. The pandemic brought valuable lessons concerning how artificial intelligence (AI) and real-world data reduce production timelines. Mark Lambrecht of SAS asserted that to continue a real-world data-driven business trajectory, companies “will reorganize, merge, and bring together digitization experts across previously siloed departments, allowing clinical trials to run more effectively and efficiently. In addition, cell and gene therapies will become digitized and contribute to the drive for more precise personalized medicine.”

Here are the full trends and predictions, including additional forecasts for potential mergers and acquisitions among big-name companies, software-driven approaches to structure and analyze data, automated data collection and clinical operations, and digital biomarkers to objectively capture real-world data from patient behaviors and experiences. – the Editors

Featured eClinical Solutions leadership predictions

Venu Mallarapu, Vice President of Global Strategy and Operations

Data flows will become automated and clinical trials will be held in the metaverse: This year, we will see an increase in the adoption of digital data flows across the industry that will lead to the automation of study setup in data collection and clinical operational systems, as well as content creation for submission pipelines and analytics for decision-making across the R&D value chain. Half of the top 50 life sciences companies will invest in a unified clinical data and analytics platform with capabilities that aggregate diverse data sets and provide analytics capabilities for submission and secondary use pipelines. Some of these may be custom-built, while most will be commercial platforms. Additionally, the industry will adopt the metaverse in clinical trials within the next three years. Potential use cases include patient education for DCTs, site enablement, medical review, and real-world data collection.

Sreekanth Gudapati, Vice President of elluminate Services

AI/ML will optimize end-to-end clinical workflows, and social media will be leveraged to improve outcomes: We will see multiple trends picking up steam that run the gamut—affecting several aspects of clinical trials. Firstly, I believe that the penetration of AI/ML techniques for optimizing end-to-end clinical trials will become more commonplace in tasks like protocol digitization to predictive shipment tracking. When it comes to data, I predict there will be a concerted push for real-time integration of data sources to achieve data integrity across multiple sources. Finally, I foresee that adopting social media in the space will improve success rates related to enrollment and data mining.

Read the full list of predictions.