Survey Finds Industry Taking Action to Address Challenges from Rapid Move to Decentralized Trials Amid COVID-19

Sponsors and contract research organizations (CROs) are accelerating digital transformation to advance toward patient-centric, paperless, and decentralized trials, according to the Digital Clinical Trials Survey Report conducted by Veeva Systems (NYSE: VEEV). The new global research shows life sciences companies are taking decisive action to improve operational challenges stemming from the rapid adoption of decentralized technologies during COVID-19, evolving to a study model that expands beyond just decentralization.

Today, most sponsors and CROs (87%) use some type of decentralized technology, up 59 percentage points from before the pandemic. With this change, companies added an average of four new applications to their clinical landscape, leading to issues with data collection and stakeholder collaboration and impacting study quality and speed.

Findings show that sponsors and CROs are taking action to address these challenges in order to streamline study execution and deliver a better patient and site experience. Nearly all respondents (95%) are working to establish a unified digital trial foundation to improve information sharing and collaboration across stakeholders, better support sites, and eliminate silos through a connected ecosystem. This will bring together patient-facing applications, sponsor and research site operations, and clinical data for end-to-end digital trials that are faster and more efficient.  

Improving engagement with patients and sites was consistently cited as a critical initiative and a driver for moving to a digital trial model. Major change is happening to address the key challenges with decentralized trials, including lack of site technology adoption (70%) and increased burden for technology-averse patients (50%). Sponsors and CROs are investing in making studies more accessible and convenient to patients by better supporting sites with technology and eliminating paper processes, efforts that can enable seamless trial execution and data flow.

"While decentralized approaches have driven positive change in clinical research, more work remains to deliver faster, more cost-effective trials," said Jim Reilly, vice president, Vault R&D at Veeva Systems. "True digital trials will connect the clinical ecosystem and deliver a better trial experience for patients, sites, and sponsors."

The full report is available online at veeva.com/DigitalTrialsSurvey.

About Veeva Systems

Veeva is the global leader in cloud software for the life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves more than 1,000 customers, ranging from the world's largest pharmaceutical companies to emerging biotechs. As a Public Benefit Corporation, Veeva is committed to balancing the interests of all stakeholders, including customers, employees, shareholders, and the industries it serves. For more information, visit veeva.com.

Research Highlights - Veeva Digital Clinical Trials Survey Report

The Veeva Digital Clinical Trials Survey Report examines the opportunities and implications of decentralized approaches on clinical trials by gathering the experiences and opinions of more than 280 clinical leaders worldwide. The report shares views on the industry's progress toward digital trial strategies, lessons learned, and key factors of success.

Accelerating Toward Trial Decentralization Models During COVID-19

• Most sponsors and CROs (87%) rapidly deployed decentralized trial approaches to minimize disruption, up 59 percentage points from 28% before the pandemic.

• Within the next 24 months, 95% say their organizations plan to increase the use of decentralized trials. 

• Investment in emerging digital trial technologies will continue, as 32% say they have adopted or plan to adopt eRegulatory / eISF for their sites within the next 12 months, followed by eConsent (31%) and eSource (27%).

Rapid Shift to Decentralized Trials Leads to More Operational Challenges

• Sponsors and CROs added four new function-specific solutions to their existing clinical landscape.

• Nearly all sponsors and CROs (99%) report significant challenges with decentralized trials.

• The top challenges with decentralized trials are site technology adoption (70%), internal change management/stakeholder alignment (59%), data protection and privacy (51%), and burden for technology-averse patients (50%).

Moving to Digital Trials to Improve Study Quality and Accelerate Clinical Research

• Nearly all respondents (95%) report having initiatives to address the system and operational challenges introduced by rapidly adopting decentralized approaches. 

• Highlighting the critical importance of reducing site burden, most CROs (66%) and sponsors (53%) are taking steps to offer sites better support with technology.

• Improving data sharing and collaboration, addressing system interoperability concerns, and eliminating paper processes are key priorities for sponsors and CROs.

What Clinical Leaders are Saying About Decentralized Trials

• "New systems and processes have led to inefficient internal workflows, challenges with collaboration, and getting information in and out of systems."

• "Decentralized trials introduce more technology, processes, and burden for the site. We need to provide a helping hand, a white-glove approach to help them with efficient execution."

• "It is essential to evaluate the relative merits of technologies but aim to use fewer applications with better connections between them."

SOURCE Veeva Systems