StemCell Therapy

We are in an age of scientific breakthroughs, particularly in areas such as personalized medicine, genomics-based research, and immuno-oncology. While science advances, theres 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.

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. Thats 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 PartnersStreamlined 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. Its hard to start a study when youre waiting on signatures on financial disclosures.If the ink signature requirement is whats 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 SourcesThere 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.Were 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 ClinicalAs 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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Better Collaboration Is Key To Speeding Trials - Contract Pharma

This entry was posted on October 21, 2019 at 10:45 am and is filed under Personalized Medicine. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed. |