Contributed Commentary by Jill Johnston

October 27, 2016 | Contributed Commentary | Johnson & Johnson’s Yale Open Data Access (YODA) project (DOI: 10.1056/NEJMp1607342) pioneered a bold new model in life sciences: sharing data from clinical trials with external researchers – all in the name of scientific advancement. Typically, sharing information in the life sciences industry has proven more challenging primarily because of siloes in place between not only companies, but also functional areas within an organization. Disparate, legacy technologies have caused these areas to become even more detached over the last two decades.

This lack of information sharing is most noticeable in clinical development. As clinical trials began expanding both in scope and complexity, companies started dedicating teams to focus on specialized functions, such as study start-up or safety. Companies then either built systems to support these specific functions or purchased off-the-shelf solutions, one at a time, piecemeal. Work was passed to the next functional expert in line but with very little thought about what was needed before or after each individual task was completed. Trials expanded globally and functions continued to diversify, as did the systems used to handle those tasks. Today, most clinical teams work with many different applications that do not enable collaboration externally or easily allow for sharing of documents and data internally.

“The clinical development process is highly inefficient due to a number of factors, including the inconsistent use of a large number of incompatible technologies,” said Ken Getz, associate professor at Tufts University School of Medicine and chairman of the Center for Information and Study on Clinical Research Participation, in an interview.

It’s not unheard of for clinical operations teams to use as many as 20 different non-integrated systems to manage global trials – from electronic data capture (EDC) systems and study start-up applications to clinical trial management solutions (CTMS)  and electronic trial master files (eTMF). In fact, the life sciences industry has invested millions of dollars in various on-premises, enterprise systems since the 1990s and now these aging technologies are hindering information sharing because none of these systems are interoperable.

Opening the Lines of Communication

In Veeva’s 2016 industry-wide survey, nearly half (49%) of all respondents cited integration between their eTMF and CTMS applications as a key need. But today, clinical and operational data resides in multiple disconnected systems, including EDC, eTMF, and CTMS applications. Study teams also obtain data from various third-party providers, which add further complexity to the clinical trial process. For example, information regarding investigational products can come from interactive response technology, a contract research organization, or an inventory management system. Endpoint data may come from various labs or imaging providers too, and few of the systems ever talk to each other.

Even with all of these technologies, most study managers rely heavily on manually compiled spreadsheets to get a view of issues across a single study or a portfolio of studies. According to another recent survey, more than 90% of study managers export data directly from their CTMS and EDC systems, only to manually roll them into a central spreadsheet with data from other systems. Spreadsheets are even still used for oversight of contract research organizations (CROs).

“Clinical operations in every part of the world are hindered by a tangled web of disparate, legacy systems,” said Michael McKelvey, executive vice president of clinical, inVentiv Health, in a phone conversation. "Interoperable technology is the foundation for unifying clinical processes – saving time, resources, and even lives. It could be transformative and set the direction for the future.” 

“We recognized the value an innovative technology solution could have in knocking down hurdles that slow progress during the study start-up phase, where improvements can have a significant impact on overall trial results,” added Rachel Stahler, CIO, inVentiv Health, in the same conversation. “An integrated, best-of-breed platform can maximize efficiencies and accelerate the delivery of much-needed drugs to patients.”

The main challenge for executives is the uncertainty that results from a lack of transparency. Gaps in the various handoffs during their key processes and lack of interoperability in their systems prevent them from knowing if the clinical studies are performing to plan. These executives lack the visibility of any impending challenges, such as lagging patient enrollment, where sites may require additional support, and what risks exist regarding study compliance. Ultimately, it prevents teams from investigating and mitigating issues in real time.

“Transparency, compatibility, and integration are critical factors driving technology adoption among clinical research professionals, patients, and the broader health care environment,” said Getz.

A unified clinical technology landscape can have a positive impact that ripples throughout the entire organization. For example, uniting three clinical systems can reduce the number of steps in the end-to-end processes of creating a protocol, collecting essential documents, supporting the submission, and finalizing the clinical study report by 60%, or from an average of 26 to just eight. With all stakeholders working on the same platform, team members can dramatically reduce the tedious back-and-forth, logging in and out of different systems, and downloading and uploading the same documents multiple times from multiple places. When systems are interconnected, information automatically flows between them seamlessly. Ultimately, this drives faster time-to-market.

Unifying clinical operations on a modern platform optimizes resources, ensures greater accuracy, and reduces risk. The biggest hurdle to this end state is unplugging legacy systems without impacting how business gets done today. In a recent executive symposium hosted by Veeva Systems, clinical executives agreed that business continuity during a technology upgrade was their biggest concern. According to participants, aging, on-premise CTMS applications can be a major bottleneck within an organization. Companies often build a custom integration between their CTMS and eTMF systems to funnel final investigational site trip reports and follow-up letters to ensure they have an inspection-ready eTMF for auditors at all times. As a result, the thought of replacing a legacy system with a daisy-chain of integrations makes management nervous. If one system is replaced, there is no guarantee that integrations will still work.

Ideally, the CTMS and eTMF, along with all other clinical systems, should be built on one, common platform, easily accessible in the cloud. This ensures that the most up-to-date documents and operational data automatically appear in the various clinical applications with the right metadata associated with them in real time, as it happens. Otherwise, the operational data and documents must be moved manually from one system to the other, creating extra administrative work and risk and hindering end-to-end visibility.

When the clinical landscape is unified on a single platform, this funnels all information into one source of truth that is always correct and up-to-date. Also, it’s easy to provide access to all stakeholders including CROs, investigator sites, and other external partners. A unified technology landscape provides one view within and across clinical trials for real-time visibility into clinical operations. The industry will be empowered to bring innovative new therapies and drugs to market faster at less cost. Sharing of certain pieces of data will allow researchers and clinicians to quickly build upon already proven theories and fruitful, efficient collaboration will finally become commonplace.