Does Clinical Operations Need a Makeover?

At Veeva Systems’ R&D conference last September, Rob Metcalf, VP of medicines development at Eli Lilly, held a fireside chat with Henry Levy, general manager, Vault CDMS, at Veeva Systems. During the chat, Metcalf discussed his views around the current state of drug development. He shared: “One of the areas that I’m very focused on is the translation of design into delivery, and the role that clinical operations plays in actually informing great design.”

He continued, “In Lilly, people are hearing me talk less about clinical operations and more about clinical delivery as a capability, as a fundamental drug development capability that has a role in partnering with our therapeutic area groups in terms of great drug development, great study design. And I think we need to position more traditional clinical operations; it’s really a core capability about delivering, delivering great outcomes, delivering great experiences for our investigators, our investigative sites, and ultimately delivering great medicines to patients who are in need.”

Metcalf said that changes in patient engagement in clinical trials, study designs, and advances in technology, including digital biomarkers, are all ways that will improve clinical development and delivery, which accelerate new medicines to patients in need.

In the spirit of change in clinical operations to clinical delivery, or maybe something else reimagined, Applied Clinical Trials decided to ask a few experts in industry if they think clinical operations needs a makeover.

Anders Persson, Clinical Transformation Leader, Digital Health R&D, AstraZeneca

Prior to leading the clinical team in digital health R&D, Persson most recently worked as head of clinical operations enablement and has been in various project and line management positions with AstraZeneca since 1995. He is passionate about finding ways to make life better for patients, partners, and society.

Persson believes that putting our faith in “new technologies, automated processes, and advanced analytics” will create the solid foundation needed, as AstraZeneca steps away from solutions originating from paper-based systems into greater digital working. He cares deeply about the company and pharma and is using his considerable experience and facilitation skills to lead the implementation of a new Unified Clinical System, which includes replacing a spaghetti of outdated clinical trial management systems and reporting processes. 

Persson shared the following thoughts:

■ “Across pharma, the backbone of ClinOps is largely paper-based, which is not sustainable or effective. Embracing technology to digitize and automate is essential to shorten timelines, drive down costs, and build in efficiency, but, most importantly, to deliver improved patient outcomes and experience.” 

■ “This is easy to say but much harder to deliver. It is paramount that organizations are ready to adopt new technology and approaches and then maintain them in order to ensure success. New system capabilities require very close collaboration across ClinOps and related functions, including IT teams, and with external partners, to achieve constant development and innovation.”

Jim Reilly, VP of Clinical Strategy, Veeva Systems

Reilly has led teams responsible for sales and delivery of clinical data standards and regulatory technologies at Accenture (formerly as part Octagon Research Solutions), and has extensive consulting experience from his time at Octagon Research, as well as HighPoint Solutions, where he led business process improvement and technology selection programs in clinical and regulatory operations at a number of large pharmaceutical

organizations. Here are some insights from Reilly:

■ “Clinical operations need a makeover to overcome the increased complexity of today’s clinical studies. Science is evolving rapidly to bring about breakthrough innovations such as personalized medicines, cell and gene therapies to fight cancers, and novel treatments for rare diseases. While these advancements bring new hope to patients, they also introduce complications, involving more partners, creating supply chain issues, and introducing patient recruitment challenges. At the same time, biopharmaceutical companies are under significant pressure to reduce costs. Speed and efficiency have become as crucial as the science, yet trials are as slow today as they were a decade ago.”

■ “Collaboration is one of the biggest issues impacting speed. Last year, former FDA Commissioner, Scott Gottlieb challenged the industry to improve collaboration across study partners with modern technologies. However, advancements have been stymied by a lack of technology solutions geared toward the unique needs of sites. While sponsors and CROs have made significant progress in adopting purpose-built technology, clinical research sites often get left out because they may lack the resources needed to invest in infrastructure, or the technology solutions are not designed to meet their specific workflows and business processes. As a result, sites rely on sponsors and CROs to provide technology for managing trial activities and collaborating during a study. With each sponsor providing a unique system to sites running dozens, or even hundreds of trials, the use of technology can become overwhelming, adding unnecessary administrative burden and preventing trials from getting started quickly.” 

■ “We need to ease the burden on sites. Advanced technology can enable a more collaborative clinical trial environment by seamlessly connecting trial partners, systems, and processes throughout study execution. The resulting gains in efficiency, visibility, and quality will enable trials to run faster, simplify data sharing and collaboration, and ultimately, accelerate delivery of breakthrough drugs and treatments to the market amidst a more complex clinical trial environment.”

Audrey Rossow, Senior Director, Clinical Operations, Pulmatrix, Inc.

To Audrey Rossow, it’s not so much as clinical operations needing a makeover as needing or setting an expectation level. Rossow’s background is in project management, clinical operations, and consulting for the past 10 years, prior to joining Pulmatrix full time last fall. In her opinion, clinical operations can be defined in different ways; so it basically depends on the background of the individual. Some companies have clinical

 project leads, clinical trial leads, lead clinical research associates (CRAs), but ultimately, what a clinical operations makeover would truly look like depends on the size of the company and what the expectations are around the ClinOps role as well as the needs of the organization.

However, Rossow notes, clinical operations is very tactical vs. strategic. “People may be saying ‘I’m too in the weeds, I need to be more strategic,’ but, again, that depends on your background and the size of your company,” she says. In larger companies, clinical operations is less diffused and more defined and integrated within larger teams. In small companies, such as Pulmatrix, where Rossow is a department of one, she has more influence in bringing to bear such solutions as patient recruitment initiatives, selecting CROs and functional service providers to work with, etc.

The “extras”-the efficiencies promised by technology vendors, the getting rid of some archaic practice, or implementing a more modern one-are well-intentioned, but lost on the resources and bandwidth of the smaller biopharma. “For a company as small as mine, and highly dependent on a CRO, there is a limit to what we can implement,” Rossow told Applied Clinical Trials. “With technology solutions, sometimes people bite off more than they can chew, and if it’s not adopted and consistently utilized across the organization, then it won’t be successful.”

But a makeover? Not so much, Rossow believes. She says resources and bandwidth are where clinical operations needs to find a middle ground based on the company size and the true trial needs.

Mike McLaughlin, Associate Director, Clinical Operations, Dermavant Sciences, Inc.

Amid the global COVID-19 pandemic and current social and physical distancing measures implemented to attempt to quell the spread, Mike McLaughlin, who helps lead clinical operations at Dermavant Sciences, noted that, “As a technology fan, I appreciate that innovations in clinical operations allow us to continue working in a 

safe environment. However, it is during the new daily norm of remote working and distance living that I’ve experienced feelings of missing closer human interaction.” He said he began to ask himself the following questions about technology’s impact on clinical trials.

• Is the amount of human interaction decreasing due to technological advances in clinical trials?

• Is there a gradual extinction of the human elements of clinical trials?

• Is there a reduction of valuable and quality working personal relationships?

• Are we creating shallow and false relationships between sponsors, CROs, and investigators/sites, and, more importantly, are we emotionally or socially disconnecting study participants? 

• Is there a need to refocus on growing meaningful human interactions within clinical trial operations to reconnect people and create memorable experiences? 

McLaughlin said: “We are working at a time when technology is useful and can accomplish great things, but cultivating a positive work experience that connects study participants and allows clinical operations to improve people’s health should be valued in the long run. When the clouds of the COVID-19 pandemic clear, I believe that we’ll refocus our efforts, utilizing the best components of technology with the valuable aspects of human interaction. After all, human clinical trials are about people.”

Darcy Forman, Vice President, Clinical Operations, Science 37

Darcy Forman, who earlier this year joined Science 37 from Firma Clinical Research, a CRO, believes clinical operations is “definitely in need of a makeover.” The following are her thoughts:

■ "Embracing innovation and change is difficult, especially for pharma and biotech clinical operations teams that are tasked with delivering studies within timelines. Implementing innovation or piloting something new can be perceived as a disruption, can make project teams feel that they are being tasked with additional work, on top of

 the original goal of delivering their study, and could be perceived to put timelines at risk. This stagnant thinking has caused innovation to stall.”

■ "There are two areas that are ripe for disruption: decentralized trial execution and clinical monitoring. Decentralized trial execution includes digitalizing clinical endpoints to provide broader use of telemedicine and adoption of mobile nursing support. The progression of these areas will accelerate the acceptance of decentralized study operations, which results in greater clinical trial enrollment potential by providing broadened geographies and accelerated drug development timelines.”

■ "Embracing technology to allow for greater direct data capture and capitalizing and solving for electronic medical record (EMR) data mining should reduce the burden and spend on classic clinical monitoring activity. Clinical operation teams needs to empower remote monitoring tasks, reduce source document verification (SDV) requirements, and innovate the way clinical trial data is monitored. By innovating clinical monitoring, the industry should see cost savings with a reduction and/or near elimination of travel costs for monitors.”