Clinical Researcher—December 2022 (Volume 36, Issue 6)

SCIENCE & SOCIETY

Jim Reilly

 

Over the past few years, managing clinical trial data has become more challenging as decentralized patient data sources grow and volumes reach terabyte levels. Instead of seeing clinical data management as a technical, back-office process separate from clinical operations, progressive leaders recognize its crucial role in improving trial efficiency to speed patient access to new and better therapies.

These leaders are developing innovative programs to integrate clinical operations and data management, driven by the need for a closer understanding of patient needs, especially in areas such as oncology. In 2020, for example, GSK set ambitious new goals for its clinical programs. The company has since exceeded those goals, reducing study builds that ranged from 12 to 21 weeks to eight weeks. GSK’s explanation for its new benchmarks was simple: Every slowdown in study startup or lock times delays the availability of oncology treatments, negatively impacting patient lives.

Clinical leaders at Boehringer Ingelheim, the world’s largest fully family-owned pharma company, also began to examine the gap between clinical needs and technology limitations much more closely to better serve patients. “Patients cannot wait to get innovative drugs,” says Dr. Uli Broedl, MD, the company’s senior vice president of global clinical development and operations, who discussed the history and goals of Boehringer Ingelheim’s One Medicine initiative at Veeva Systems’ recent R&D and Quality Summit.

The initiative aims to establish an end-to-end development platform that connects different operational and clinical data flows and automates processes. This will help Boehringer Ingelheim build a core technology engine to enable a unified, connected approach to clinical trials and product development.

Establishing a Strong Foundation for Change

Ultimately, technology is the key to improving clinical trial execution, Broedl says, but it requires a foundation based on process improvement and standardization. It also depends on having teams that approach their work with a patient-first mindset, possess the right skills, and are comfortable working at the intersection of clinical research and information technology (IT).

Change efforts at the company started with a transformative initiative called Medical Excellence, focused on developing the right employee mindset and consolidating and optimizing existing processes. Boehringer Ingelheim is also building a data lake to organize and centralize data, an effort that will eventually allow clinical data to improve decisions in areas such as quality and recruitment.

The company shifted from a “best of breed” IT system landscape to establishing a core technology engine to enable a unified, connected approach to clinical trials. This year, Boehringer Ingelheim launched One Medicine Platform, implementing cloud-based systems across clinical operations and data, regulatory, and quality management that are built on a single platform. Taking this approach will enable process automation by connecting data flows. “Once we have a good interface and uniform data layers, we can build bolt-ons to drive predictive analytics along the clinical development journey,” Broedl says.

The Need for Connected Data

Change is essential to improving clinical trial efficiencies because today’s clinical IT systems at Boehringer Ingelheim are complex, fragmented, and slow, forcing teams to focus on system maintenance and limiting their ability to bring added value to patients.

Broedl emphasizes the need to prioritize connectivity both within clinical and across functions.

Instead of various sources of truth due to multiple different systems, sponsors need one source across all systems. This approach will eliminate the scenarios playing out at many life science companies today, which include:

• multiple IT systems that cannot speak to each other without custom connections;
• complex workflows requiring expensive workaround solutions; and
• user interfaces that are difficult to work with and require end-users—especially at research sites—to log in and out of multiple systems daily.

Understanding Patients and Their Needs

Despite the industry’s focus on patient centricity, clinical teams may still need to refine their perceptions of what patients need most. Instead of taking a transactional approach, in which performance is evaluated based on classical key performance indicators, teams should adopt a broader, patient-based perspective from the beginning when clinical programs and trials are being planned.

This approach will change their view of end-to-end customer engagement and lead to better results. Embracing connectivity across functions allows information flow and enables clinical teams to work together instead of in silos with separate data within electronic data capture products, clinical trial management systems, and trial master files.

Unifying Healthcare and Clinical Data

Broedl envisions a future where patient and site experience can be further improved as data from clinical and business platforms, such as for customer relationship management, come together. After all, he notes, healthcare professionals and clinical investigators “are the same people.”

Change on that scale will take time, but Boehringer Ingelheim’s business leaders are optimistic that One Medicine will improve clinical efficiency by unifying clinical data and operations to create a greater connection with research sites and patients. In the end, a focus on patients must drive these efforts and others like them in the industry. Success will be based not on incremental operating improvements, but on patient outcomes.

 

Jim Reilly is Vice President, Veeva Development Cloud strategy, with Veeva Systems in the Greater Philadelphia area.