The length of the medtech product development lifecycle, three to seven years from concept to approval,¹ drives the industry to find ways to accelerate clinical trials. But clinical leaders face many challenges that slow down studies, including study build timelines, protocol amendments, data management activities, and patient recruitment. Factor in the additional obstacles added by COVID-19, and more companies are rethinking how trials are run. 

The pandemic fast-tracked modernization efforts out of necessity to keep studies going. Medtech embraced digital ways of working and new technologies that enabled remote execution and data management, like remote monitoring. Building on this momentum, companies are now optimizing clinical research to create digital links with study stakeholders for seamless information exchange in trials. Efforts are shifting to establish a global, digital foundation that enables a more patient-centric and connected approach. 

Advancing Transformation in Clinical Trials

The rate of mergers and acquisitions in medtech makes it hard to establish a connected global infrastructure. For companies with numerous disparate systems, significant change is needed to understand what critical processes exist, how they can be improved, and what processes are unnecessary. To start this journey, you must first evaluate how trials are conducted, ensure the right internal and external teams are involved, and prioritize technology evaluation.

John Acampado, senior manager of clinical affairs at BD, continuously explores ways to drive efficiency across the clinical organization: “We wanted to have everything under one roof and work with a forward-thinking partner to help us streamline,” he said.

With processes mapped and the right people in the room, look for systems that enable connectivity across the clinical ecosystem. Rethinking trial strategies, moving beyond using multiple function-specific eClinical solutions, and promoting better collaboration with research sites can elevate trials for greater efficiency and speed.

Improving Collaboration with Research Sites

Site monitoring has been primarily conducted in person and takes four to eight weeks to complete.² A lack of access to sites during the pandemic led many clinical leaders, like Marla Kuleszynski, senior clinical study manager at Exact Sciences, to implement remote monitoring as an option for her studies. “I used to pull that out of our contracts,” she said. “Now, sites are expected to have a plan in place for remote monitoring.”

By using digital and connected systems for clinical execution, BD makes things simpler and more efficient for sites. “There have been high attrition levels at sites,” said Acampado, so they are focusing on finding ways to make information transfer from sites a seamless process. “Automation will be our friend,” he added.

The shift to digital has improved the sponsor-site relationship by streamlining processes, making it easier to access information, and simplifying reporting. For Exact Sciences, examining their site management and data review strategies revealed opportunities.

“Advanced clinical systems track metrics and issues and allow us to spend our extra effort with sites that need the attention,” said Kuleszynski. “This approach allows us to be smarter about handling our site monitoring.”

Standardizing remote monitoring is a priority across medtech to help reduce the burden on sites. With the proper tools, sponsors can speed execution and proactively identify issues, and sites can spend less time on administrative requests.

Driving Value and Efficiency

“The way we’re going to deliver value to our patients is to be forward-thinking. We can’t continue to do trials the same way, and the momentum from the pandemic has pushed us to learn how to do things better and smarter,” said Acampado.

“How can we take advantage of the resources and infrastructure we’ve already created to find efficiencies?” asked Kuleszynski, who began to use the same forms and edit checks to save on time and resources at Exact Sciences.

Adopting patient profiling instead of using more traditional models, like risk-based study management, can streamline execution. Clinical teams can quickly access data to identify essential issues and reduce the study’s administrative requirements. BD, for example, uses past data to identify critical points in a trial, adding resources and edit checks that increase efficiency.

Maintaining the Momentum with Digital

As more medtech companies embrace digital strategies, clinical trials have increased remote activities and data collection. This makes it easier for patients to participate in trials and allows sites to focus on value-added processes. The advancements will improve the patient experience and lead to better retention while positioning the industry to manage unforeseen challenges like the pandemic. Medtech companies have realized significant improvements, including:

Speed and data quality: By collaborating on documentation digitally, staff can execute processes faster and ensure the accuracy of information. Patients can also report outcomes more quickly instead of scheduling an appointment or calling in results.

Patient enrollment and participation: The use of digital tools like virtual visits or eConsent, an application that enables digital patient consent, makes it easier for patients to participate in trials. It also provides more flexibility to expand studies beyond the zip code of a research site, improving patient access to treatments and sponsor reach into more diverse patient populations.

Participant retention: Dropout rates in trials rose to 19 percent in late-stage studies globally during COVID-19, up from 15 percent in 2012. Digital solutions deliver greater convenience for patients, and both sponsors and investigators report that it helps increase enrollment and lower dropout rates.³

Collaboration across stakeholders: With a digital and connected clinical ecosystem, information sharing is seamless. This ensures high-quality data and lets teams execute workflows to move processes forward quickly.

Medtech companies focus on maintaining the momentum from advancements made during the pandemic by continuing to establish more efficient ways to share information and conduct studies. The clinical trial operating model is evolving as the industry embraces new, more connected ways to execute clinical research for greater efficiency, high-quality data, and improved site and patient engagement. Medtech leaders are implementing technology and processes that will streamline study execution, make it easier to share information, improve collaboration across stakeholders—and ultimately, get safe and effective products to patients faster. 

References

1. TWI, What is the Medical Device Design Process? 2022
2. FDA, Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring, 2019
3. ACRP, The Modernization of Clinical Trials: COVID-19’s Lasting Impact, 2021

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Ami Dudzinski Mehr is a results-oriented senior leader with over 20 years of professional services experience. Ami has devoted her career to implementing EDC and IRT/IVRS software for clinical trials. Ami is currently part of the Vault CDMS leadership team, responsible for strategy in the medtech space. Earlier in her career, Ami was responsible for trial build and enablement delivery at Oracle and Phase Forward. She holds a B.A. in the mathematical and physical sciences from Wells College, Organizational and Strategic Leadership Certificates from the Simmons University School of Management, and a Leadership Certificate from Babson College.