he life sciences industry continues to innovate and develop breakthrough cures and treatments at a rapid pace. The US Food and Drug Administration (FDA) approved 46 novel drugs last year—more than double the previous year—and 2018 is expected to see a record number of new drugs introduced.

As innovation has increased, so has outsourcing to clinical research organizations (CROs) as a way for sponsors to run trials faster, improve efficiency, and add services with greater specialization. By 2020, sponsors are predicted to outsource 72 percent of clinical trials to CROs, up from just 23 percent in 2012. Adding further complexity, life sciences companies typically outsource to multiple CROs for a single study.

“The more people working on a project, the more complicated it becomes,” explained Rhonda Henry, vice president, site networks and patient centricity, PPD, a leading global CRO. “There may be one CRO doing the IVRS and another supplying drug to the sites, but they are all interdependent. The data hand-offs from one CRO to another may not always be smooth. Information can get lost in translation, and oversight is difficult. Collaboration is, at best, limited.”

As the mix of CROs, investigators, and regulators grows, information sharing and collaboration becomes challenging. Technology plays an important role in managing this complex mix of trial stakeholders, but because each trial participant uses a mix of different software applications, barriers exist in communication and exchanging clinical data.

“Too many technology barriers, layers of participants, and endpoints in clinical trials hinder collaboration,” said Jeff Kingsley, founder and CEO of IACT Health, an integrated clinical research site network with 13 locations. “We’re at a breaking point where people, processes, and technology must change to continue to innovate.”

There is a significant opportunity for the life sciences industry to find a common way to bring together trial stakeholders, simplify information exchange, and improve collaboration across sponsors, CROs, investigators, and regulators. A clinical network will be key to linking systems and automating the flow of trial data and documents for greater visibility, efficiency, and oversight.

“It’s all about maximizing efficiency,” said Kitty Yale, vice president of clinical operations at Gilead. “Information transfer is cumbersome; even if you use digital repositories, you’re still just picking up and dropping off documents. What we all want is an automated, pull-through solution.”

The Clinical Network: A New Approach to Sharing Trial Information

Imagine a network where everyone involved in a clinical trial sees and shares the same information. In travel, when a flight delay occurs, data is immediately available on airport screens, through a web search, and an airline mobile application. The same data is shared across multiple, separate systems so no matter where you are or what channel you use, you have access to the latest information. Applying the same automated connectivity to clinical trial information would make stakeholder collaboration just as fast and easy.
Interoperable systems are key to a clinical network connecting sponsors, CRO partners, investigators, regulators – and eventually, patients – and automating the flow of information across trial processes. A clinical network in life sciences would eliminate the need for emailing files, mailing flash drives, and other cumbersome methods of information exchange. And, unlike portals or investigative registries that require manual intervention to share information, a clinical network could eliminate manual data entry and potential for human error.

Fortunately, technology has matured to the point where the clinical network can become reality and the industry can overcome the three biggest roadblocks to collaboration.

1. Break down data siloes to improve visibility and speed

Data siloes have emerged as sponsors and CROs have increasingly replaced paper with function-specific eClinical applications. While the industry has progressed in adopting modern systems, disconnected applications prevent participants from getting a complete view of trial processes and significantly slow trial execution. In fact, the majority (74 percent) of sponsors and CROs cite integrating multiple applications and managing content and data across them among their top challenges.

“While modern eClinical technology is becoming the norm, clinical processes remain flawed as stakeholders use different applications that don’t integrate,” explained Jessica Ibbitson, vice president of Clinical Operations, ProQR Therapeutics, a Dutch-based biotech that develops RNA therapies for rare genetic diseases.
A clinical network would remove data siloes and speed up the flow of operational and patient data across clinical applications from sites to CRO partners, and eventually to sponsors and regulators. Instead of working in multiple, disparate systems, clinical teams could align on a single platform for full visibility of operational and patient data throughout their trials.

Trial participants could also eliminate redundant data entry in multiple systems and more efficiently hand off information. Sponsors, CROs, and investigators could skip the extra step of uploading data to transactional portals because information would automatically sync in real-time and changes would be reconciled in every system in the clinical network. Ultimately, this could significantly speed study start-up and overall trial execution.

2. Drive more efficient processes for investigators and CROs

Investigators often shoulder the burden of transcribing the same patient data multiple times into different systems such as an EDC, CTMS, eTMF, ePRO, and investigator portal—for the same study. A recent CenterWatch study reports investigators use an average of 10 or more software applications for one study. This creates redundant work and impacts team morale as staff are pulled from patient care to handle more administrative tasks.

“Stakeholders are overwhelmed by the number of technology options and how they all piece together,” explained PPD’s Rhonda Henry. “In one example, a sponsor employed five different wearable technologies plus other applications for one trial. While difficult for a CRO to manage, imagine the challenges for an investigator who must sort through all of these systems, especially as he or she is involved in multiple trials with different CROs and sponsors. It’s a lot for sites to learn and manage, considering patient care is their priority.”

In a connected clinical network, information would be entered once and streamed to all stakeholders so organizations spend less time on administrative duties and more on trial execution, patient engagement, and scientific innovation. With data and documents available in real time, trial participants can collaborate more easily to focus on decision-making and proactively resolving problems.

Disconnected systems also interrupt daily work and add inefficiency. Research staff manage different login credentials across many systems, moving in and out of different applications to complete routine tasks. Norman Goldfarb, managing director of First Clinical Research and chairman of MAGI, explained, “A study coordinator might have 20 or 30 different log-ins across multiple studies.”

Managing different technologies also contributes to investigator attrition and why sponsors struggle to find seasoned investigators to run their trials. According to Ken Getz, associate professor and director of sponsored research at Tufts CSDD, many principal investigators retire from research after one study.

“We must urgently ease burdens on investigators conducting clinical trials, particularly as investigator turnover increases,” said Kingsley. “We have to change our processes to allow physicians to be successful in research by enabling easy collaboration and removing unnecessary strains, so we can increase the pool of experienced investigators.”

A clinical network reduces the workload for improved site engagement. Automating information sharing relieves busy researchers of burdensome administrative work and re-typing information in multiple systems. For sponsors, the ability to seamlessly transfer data during trials would also enable them to run smoother trials so investigators are more likely to support future trials.

3. Establish seamless connectivity for greater oversight

The recent addendum (R2) to ICH-E6 mandates sponsors be more accountable for trial execution and information quality, even when outsourcing to CROs. As CROs take on more trial responsibility, sponsors must actively oversee them all. But it’s difficult.

Legacy technology makes it challenging for CROs and sponsors to collaborate and automatically share information in the same systems. As a result, they often resort to passive methods such as sending reports or non-standardized data back and forth manually.

These outdated modes of information sharing cause technical and operational problems. For example, IT teams must develop and maintain complicated integrations and data standards across technologies and when this is too burdensome result in disconnected systems that hinder operational oversight.

“While sponsors contract CROs to serve as intermediaries with investigators, they sometimes inadvertently create barriers and hinder communications between the physician and sponsor,” said Kingsley. “These effects can be harmful to clinical trials and prevent innovation. We must open the lines of communication to better understand expectations and collaborate.”

By unifying clinical processes, systems and people, the industry can address these obstacles. In fact, nearly nine out of 10 (87 percent) clinical teams are making plans to unify operations so information can flow between applications.

The promise of a unified operating model can be fully realized with a clinical network that brings together sponsors, CROs, and sites and provides total visibility across both internal and external trial processes. Both sponsors and CROs would also gain comprehensive trial oversight and greater control. Regulators would see all important documentation with their audit trails, while investigators enjoy more direct communication with sponsors and CROs.

“Unified clinical technology not only benefits trial sponsors but also investigators, which allows them to focus less on administrative burdens and more on meaningful work,” added Gilead’s Yale. “Any solution that frees up resources for sites benefits all—patients especially.”

“Many companies will implement new technology to meet a specific regulation or need rather than investing in a robust solution,” explained Ibbitson. “As more people talk about unified technology systems, sponsors are starting to evaluate the upside of making a more significant upfront investment to gain long-term benefits. This is crucial to collaboration—and success—in clinical trials. It’s time to switch to a platform that enables a clinical network.”

A clinical network automates clinical data exchange across all parties involved in a trial. This model connects eClinical applications to enable true collaboration from study start-up to close. Stakeholders benefit from the following:

• Full transparency into trial activities from study start-up to close, allowing greater oversight and better decision-making throughout trials.
• Automated information flow and elimination of manual tasks, redundant data transcription and administrative activities for greater focus on trial execution.
• Real-time communication between all constituents for greater engagement, oversight, and problem-solving.

Improved Collaboration Will Bring New Life to Life Sciences

In the era of outsourcing, the success of the life sciences industry in bringing new products to market rests, to a large extent, on the ability of sponsors, CROs, and investigators (plus regulators and patients) to work together successfully in a collaborative partnership. This partnership must operate with open communications to foster a foundation of trust and mutual commitment. Fortunately, the industry is starting to form more collaborative partnerships, seeking to incorporate investigators and patients more directly into the trial process with modern technology.

“It is critical that industry continues to work together to identify new ways for collaboration between sites, sponsors, and CROs, to create space for real change to occur, and to be receptive to new and innovative ways of performing trials and treating patients,” concluded Jimmy Bechtel, senior project manager at the Society for Clinical Research Sites (SCRS). “In five years, we hope that participants will have a much closer relationship where collaboration is enabled and supported by advanced, integrated technology designed with users in mind. Technology will not be a hindrance, but rather will make the trial process faster and more efficient by unifying trial operations.”

We are at the stage where a clinical network can make this a reality and improve trial collaboration throughout the life sciences industry. Yale concluded, “An automated network will deliver significant time savings, where everyone benefits with more time for research, patient care, and life-changing science.”

References available upon request.