Three Steps to More Connected, Efficient Clinical Research

Henry Levy
Veeva Systems

he life sciences industry is accelerating modernization efforts to reduce COVID-19 disruptions, keep existing trials on track, and start new studies faster. Yet, there is still more work to be done to improve information sharing and collaboration across studies. In fact, sponsors and CROs report a need for better information exchange in trials to reduce manual processes (75%) and improve visibility and oversight (58%).

Companies can advance how trials are run by leveraging the FDA’s Technology Modernization Action Plan (TMAP) as a guide to digitize processes, improve how teams work together, and accelerate towards paperless, patient-centric approaches. FDA outlines three parts to TMAP, including guiding decision-making with real-world use cases, bringing external and technology partners into the conversation to drive continued innovation, and modernizing infrastructure with a cloud-first strategy.

Here are three steps to run more connected and efficient studies.

1. Inform Decision-Making with Real-World Use Cases

Organizations that define specific use cases can identify what does not work and where there are process gaps. Use cases allow for testing and expanding real-world application of technology and help teams prioritize efforts to streamline. For clinical trials, pinpointing where modern solutions increase efficiency and speed execution is critical to accelerating studies.

For example, the FDA identified a use case in which they needed to figure out how to transfer seven- and 15-day safety data for INDs. Leveraging APIs, they were able to receive structured information directly from the source. Use cases provide insights for sponsors, CROs, and sites into the causes of delays and redundant user tasks in clinical trials.

As part of TMAP, the FDA is developing use cases that showcase different ways to leverage data. There has been an explosion in the amount of data available to the life sciences industry, but without clear application, many companies have not figured out how to use them. Modern systems that bring data together and applications that collect patient outcomes via wearables are a few ways technology can enable the industry to apply real-world data (RWD) into clinical research.

“More sponsors want to understand how they can leverage healthcare information derived from sources outside of typical research settings, including wearables, sensors, and smartphones,” said Tanya du Plessis, vice president, data strategies and solutions at Bioforum, a data-focused CRO. “They are interested in how RWD sources can potentially be used to more precisely define the types of patients who would benefit most from a given therapy and to provide a better picture of a patient’s quality of life. Such insights can enable smarter clinical trial design.”

“However, a concern is having the tools to collect, analyze, and integrate the data in a scientifically rigorous and efficient way to use the insights from these new sources in a timely and meaningful manner. It’s critical to thoughtfully map out a data collection and management strategy that, from the start, builds in flexibility to encompass RWD if needed,” du Plessis adds.

“We’ve been provided breakthrough designation or accelerated approval because of really great data,” said Leila Ponce, clinical trial manager at Seagen. “It comes back to our modern eTMF systems and how we’re able to aggregate, clean, and prepare information for even quicker submissions and approvals.” With advanced cloud systems that automate and optimize clinical processes, Seagen can prepare data for regulatory submissions faster.

2. Collaborate with Partners to Drive Progress

Involving stakeholders across clinical research is key to driving continuous improvement. When evaluating how to streamline clinical operations, include sponsors, CROs, sites, patients, or technology partners to collectively drive new ways of working together.

Governing bodies are recognizing technology as a vital part of the clinical research ecosystem. This means that new solutions are likely to be accepted faster because there will be ongoing communication between the industry and the technology communities. Maintaining an open dialogue with partners drives progress.

One area benefiting from industry collaboration is patient consent in trials, a process still collected mostly on paper and managed manually. eConsent, an entirely new approach to managing patient permissions, streamlines and simplifies the consent process from authoring to patient signature. Patients review documents and protocols and provide consent from their mobile phones. By using digital solutions for patient consent, sponsors, sites, and technology partners are working together on behalf of patients to make participating in trials easier.

3. Modernize Infrastructure and Operations to Streamline Processes

After identifying real-world use cases and collaborating with partners to explore innovative approaches, companies should focus on modernizing clinical trial systems. COVID-19 highlighted the limitations of legacy applications, including a lack of visibility and manual processes that slow down research. To speed trials, industry accelerated modernization out of necessity. But adopting clinical applications built on a cloud platform offers several long-term benefits, including digitizing data and processes, removing system silos, and dramatically reducing reliance on paper.

FDA’s move to the cloud through TMAP supports the industry-wide shift to progress clinical operations in the industry. “The first thing that we’re going to revitalize is the technical infrastructure of the FDA, ensuring that we are cloud-forward and have the people, deliberate processes, and right budget to succeed,” said Amy Abernethy, principal deputy commissioner of the FDA. “We want everything in place to make sure that we have an infrastructure that we can rely on.”

Establishing a foundation with cloud-based solutions allows sponsors, CROs, and research sites to apply more digital, remote ways of working like enabling virtual patient visits or remote monitoring during trials. Ultimately, cloud applications can streamline information flow, simplify processes, and deliver efficiencies that speed research.

Fast-Track Innovation in Clinical Research

FDA’s implementation of TMAP will help drive positive change in the industry and a more modern way of managing regulatory reviews. Organizations can apply the methods used in TMAP to streamline clinical operations and deliver drugs to patients faster.

Real-world use cases provide insights into what does and does not work. Collaboration with stakeholders can build strong relationships across the clinical research ecosystem and help advance trial processes. Clinical applications built on a cloud platform can set the foundation for decentralized trials that deliver more patient choice, lower patient burden of participating in studies, and reduce administrative tasks for sites.

COVID-19 has been a catalyst in life sciences to modernize how trials are run and advance clinical research. But industry is now entering an era where clinical development will be much more connected and efficient. With high-quality data, active collaboration with study partners and technology providers, and the successful application of modern solutions, organizations can reach new levels of improvement to deliver innovation and treat more patients.