We are in an age of scientific breakthroughs, particularly in areas such as personalized medicine, genomics-based research, and immuno-oncology.  While science advances, there’s still a major opportunity to improve how organizations work together across the clinical environment. The increased focus on a new class of medicines is creating new challenges across the drug development process that slow trial execution. Collaboration, for instance, is one of the biggest issues impacting speed.

This year, former FDA commissioner, Scott Gottlieb, challenged the industry to improve collaboration across all participants in research with modern technology. At the Veeva R&D Summit, I sat down with experts from clinical research sites, academia, CROs, and sponsors to discuss opportunities to automate information exchange, streamline processes, and leverage new technology and data sources for faster drug development.

Automating Information Exchange

In a recent industrywide survey, all clinical leaders reported the need to improve information exchange among study partners. On average, they utilize at least three methods to share trial data and documents among sponsors, CROs, and sites, with email as the primary tool. At clinical research sites, a lack of common technology creates obstacles to seamless data sharing between trial partners.

“One of our biggest challenges is working with so many different sponsors’ IT systems,” said Rachel Sheppard, clinical research director at the University of Louisville. “If any one undergoes a system or personnel change, we have to re-communicate information, even after we’ve collected essential documents in the trial master file. Managing a small change can become a big issue for us,” she said.
 
Sites can conduct clinical research for hundreds of sponsors at one time, requiring them to learn many different sponsor systems. Multiple systems also means multiple, individual log-ins to manage trials, which slows trial execution and adds to site burden. 
 
Dawn Hawkins East, director of clinical data management at Eli Lilly, pointed out one of the many data inefficiencies today. “Often, sites must enter everything twice. For instance, they have to re-enter patients’ EMR information into the sponsor’s EDC system, which makes up about 70% of the data entry at the sponsor level,” said East. “That’s too much and delays getting medicines to patients. We need to automate.”
 
Atlantic Research Group (ARG) is a global leader in oncology, immunology, rare and neurodegenerative disease clinical trials management. Acting as an intermediary between sponsors and sites, ARG faces its own collaboration challenges due to disconnected systems and processes.

“The lack of technology geared toward their unique needs can make sites jobs more difficult and distract from the important work that they are passionate about – the medicine,” said Hunter Walker, CTO at ARG. “Ideally, sponsors should be able to keep their finger on the pulse of our operations, too. That’s something that all CROs should strive for,” said Walker.
 
AstraZeneca is focusing on being a sponsor of choice for research sites and CROs, so the company is prioritizing efforts to automate information exchange. “The information we all need is sitting in isolated siloes across the clinical trial ecosystem but requires multiple emails back and forth to get it,” said Doug Schantz, executive director of clinical operations at AstraZeneca.
 
Streamlining Processes for Trial Partners
Streamlined process flow between sites, CROs, and sponsors remains an industrywide issue. As Schantz said, information sharing is the next horizon.
 
“We need a complete paradigm shift from transactional interactions with partners to connected relationships where what we need is already available in the clinical trial ecosystem,” said Schantz. “With better united, networked systems across stakeholders, no one wastes time emailing back and forth and can instead focus on the science and the patients.”
 
East discussed the importance of open lines of communication, particularly regarding feedback to sponsors after a trial is complete. “With more feedback to sponsors, we can improve process flow in the next trial,” she said. “We want constant communication from the sponsors and CROs to the sites. And that should happen in a more efficient way than email.”
 
Using eSignatures is another way to speed trial execution. “Physical signatures on paper slow everything down when there are physicians located in 11 hospitals as we have,” added  Sheppard. “It’s hard to start a study when you’re waiting on signatures on financial disclosures.”
 
“If the ink signature requirement is what’s holding up getting patients the treatments they need, we need to change,” East agreed.
 
Walker offered a potential solution. “One way forward is for sponsors to invest more in common technology platforms for sites. Very simply, fewer emails are key,” said Walker.
 
“The administrative minutiae are what hold sites back from getting trials going quickly. And these setbacks could be resolved with better technology,” added Sheppard.
 
Leveraging Patient-Generated Data and New Data Sources
There is an enormous amount of patient data collected during a treatment or therapy. Innovations like wearable devices and sensors offer promise in collecting new patient data. The question is how to use all this data to speed trial processes — and gain insight into disease.
 
“We’re sitting on a mound of patient data from sensors and wearables,” said East. “I once heard someone from the FDA say that 80% of the data we collect is only used once. That has to change. With the data collected from wearables, we can gain valuable insights into disease states, how drugs are operating, and how to design trials that provide better outcomes for patients,” she added.
 
Walker noted that we are still in the early days of using wearables to gather patient-generated data. “There are a lot of logistics,” he said. “We want to know how often things break and which tools are most effective. Are their systems to process all of this patient data through machine learning? Technologies like sensors and wearables are in their infancy, but we need to start now to get a jump on the experimentation needed to incorporate these devices into the process.”
 
An Exciting Frontier in Clinical
As scientific innovations continue to emerge, the panel agreed that advanced cloud-based platforms and data analytics technology can help processes keep up with breakthroughs in drug development. A day matters when manual processes get in the way of patients receiving life-saving therapy.  Automation in a networked clinical trial offers a solution.
 
“The life sciences industry is behind. Without automated processes, we will continue to send six emails and use Excel spreadsheets to review the safety data of a clinical trial. We went from paper to electronic, but we need to go from paper to digital so we can automate. Then we can better align and run trials faster,” concluded East.

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Jim Reilly is vice president of Clinical Market Strategy at Veeva Systems, where he is responsible for defining the market approach for the Vault Clinical suite of products. For the last 15 years, Reilly has held a variety of senior positions in life sciences technology, where he has led software delivery and sales efforts in regulatory, clinical data standards, and content management. Reilly holds an MBA in Information Systems from Villanova University and a B.S. in Neuroscience from the University of Scranton. He can be reached at james.reilly@veeva.com