The Industry’s Move Toward Digitally Connected Clinical Trials

This video provides an in-depth exploration of the pharmaceutical industry's rapid adoption of digitally connected and decentralized clinical trials (DCTs), based on findings from the Veeva Digital Clinical Trials Survey. The discussion, led by Veeva executives April Lewis and Oriol Serra, establishes that while the industry has shown an unprecedented willingness to innovate—driven largely by the "agile operations" necessitated by the pandemic—it is struggling to operationalize these new models effectively and realize expected efficiency gains. The core of the presentation focuses on three major areas where fragmentation and lack of interoperability are creating significant challenges: site experience, patient experience, and data management.

The speakers highlight a critical disconnect: 87% of respondents are now conducting DCTs (with a forecast of 95%), yet the number one challenge remains the adoption of technology by sites. This is attributed to technology being designed primarily for sponsor needs rather than providing tangible value or removing transactional burden for sites. For instance, only 29% of respondents reported improved site engagement, suggesting that simply providing single sign-on access to a fragmented suite of low-value solutions is insufficient. Furthermore, the push for patient optionality in study design (hybrid trials) is creating a "niche-mosh" of working styles for sites, increasing complexity and potentially leading to high PI turnover.

The analysis concludes that achieving scaled, steady-state digital trials requires a foundational commitment to interoperability. CROs are currently leading the adoption pace, implementing four new patient/site-facing solutions on average, nearly twice the rate of sponsors. However, this rapid, fragmented adoption introduces significant risk to data quality and speed. The speakers stress that data governance must be established first, treating data connectivity as an extension of existing core systems (CTMS, TMF) rather than a new, ad-hoc effort. The ultimate goal, as championed by Veeva, is to create a fully connected ecosystem that links people, processes, and data—vertically and horizontally—to ensure seamless information exchange and proactive risk management across the entire trial journey.

Key Takeaways: • DCTs are now mainstream, but efficiency gains are lagging. While 87% of the industry is conducting decentralized trials (projected to hit 95%), operationalizing these new models effectively remains a major hurdle, with nearly half of respondents challenged by implementation and only 56% seeing positive impacts on patient retention. • The primary bottleneck is site technology adoption. Despite significant industry effort, only 29% of respondents report improved site engagement. The speakers argue that this is because technology is often built for sponsor needs, not to provide value or remove transactional headaches for sites. • Technology must be multifaceted to succeed. Effective solutions should remove administrative/tactical burden, provide visibility into study and patient status for all stakeholders, and offer necessary training and support embedded within the application to simplify the user experience. • Rethink site selection criteria. Given the shift in operational models, the industry must move beyond outdated KPIs and incorporate new indicators, such as a site's network connectivity, early adopter status for technology, and performance against new digital key performance indicators (KPIs). • The rise of the "Digital Research Navigator" signals fragmentation failure. The emergence of specialized roles at large institutions dedicated solely to helping sites and patients navigate new technologies indicates that the current fragmented technology stack is creating significant complexity and barriers to entry. • Sponsors must adopt a portfolio-level commitment to digital transformation. Allowing study teams to pick and choose technologies ("not my trial, it's too complicated") compromises scale and value. Enterprise standardization, though challenging, is necessary to effectively manage the complexity introduced by patient optionality. • Data strategy and governance are foundational. With the mean number of endpoints increasing and trials collecting millions of data points, establishing formal data strategy and governance models is crucial to manage compliance, accessibility, and ensure that data collection is purposeful ("collect what we're going to be using") rather than speculative. • Interoperability must connect people, process, and data. Veeva’s framework emphasizes connectivity not just between systems but also between stakeholders, ensuring that data captured at any point (e.g., patient data collection) flows seamlessly for oversight, risk management, cleaning, and archiving. • Technology vendors must treat patients and sites as customers. The patient experience is often fractured because technology is built without a direct customer relationship. Accountability for the patient experience is shared among the tech company, the sponsor, and the site, necessitating a human-centric model. • Avoid treating technology as an inclusion/exclusion criterion. While technology is a great enabler for access, the industry must plan for different levels of adoption and support, ensuring flexibility in data capture methods to avoid alienating patients without internet access or necessary devices. • Leverage technology to rebuild human connection. By automating tactical and administrative tasks, technology can free up time for sites and sponsors, allowing virtual visits and other interactions to focus more on relationship building, trust, and patient adherence, rather than just task completion.

Tools/Resources Mentioned:

• Veeva Digital Clinical Trials Survey
• Veeva Vault Clinical Operations Suite (Implied core platform)
• CTMS (Clinical Trial Management System)
• TMF (Trial Master File)
• eConsent and ePRO (Examples of patient-facing applications)

Key Concepts:

• Digital Trials: Defined as how data is collected and shared through technology, applicable across all trial models.
• Decentralized Trials (DCTs): Defined as where the trial is conducted (e.g., patient homes).
• Agile Operations: The rapid, iterative, daily reorganization and prioritization of clinical processes adopted by sponsors during the pandemic to maintain business continuity and accelerate innovation.
• Human-Centric Model: A proposed approach to clinical development that acknowledges that industry professionals (sponsors, sites) are also potential patients, leveraging this universal experience to drive better design.

Examples/Case Studies:

• Pfizer's Pandemic Pivot: Oriol Serra, formerly of Pfizer, described upscaling agile methodology to all operations, forming daily alliances with epidemiology centers, and rapidly incorporating new algorithms/products to manage the chaos and maintain study continuity.
• GSK Portfolio Visibility Challenge: April Lewis shared her experience at GSK trying to maintain portfolio visibility during the pandemic, requiring integration of four data sources (CTMS, enrollment forecasting, Johns Hopkins data, and local country feedback), highlighting the enormous effort required for even minimal visibility.
• Leopharma: Mentioned as an early adopter committing to Veeva's full digital platform (site, patient, and clinical operations) at an enterprise level.