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Q&A explores the evolution and challenges of new technology implementation in clinical trials.
Applied Clinical Trials spoke with Christine Hurley, chief operating officer for 4G Clinical, a new entrant into the randomization and trial supply management (RTSM) space, about making the transition from the industry sponsor side, where she was most recently associate director of clinical systems and technology with Biogen Idec, to the supplier business. She also discusses the evolution and challenges of technology innovation and its implementation across the drug development enterprise.
Q:It’s been over a year since you left the sponsor side for the vendor side. What is the most important thing you have learned-from either viewpoint-that you didn’t know before?
That there is no single best technology solution, or strategy, for every company. What does that mean? While it might be considered an emerging best practice to use a particular type of technology to support a certain business process. For example, buying and implementing a centralized temperature deviation database to manage cold chain excursions. It isn’t necessarily right
for every organization to buy one at this moment to meet their business goals. In fact, it can have the opposite effect and be so disruptive to the business that it backfires and turns companies off to innovation.
When technology implementation fails, it is often perceived as a fault of the system itself, when it is more often a change management failure. I am a huge proponent of applying technology wherever you can, but it is essential that an organization develop a technology strategy that enables their business goals and prioritizes technology implementation carefully. It is crucial that technology vendors understand their clients’ business and technology strategies and how their particular software fits into that strategy so they can best partner to help their clients succeed.
Q: When it comes to innovation, many seem ambivalent that it equates to real change or improvement. When do you know that an innovation is truly impactful? How is that measured?
I do think there is some weariness in industry about the term “innovation.” I’ve heard many comments along the lines of “oh, everyone says their system is innovative or they are innovating”-what does that even mean? Impactful innovation in our industry at the highest level, to me, means directly improving the lives of patients. How do you measure that? Does your software significantly shrink timelines and speed up a business process? Does your software improve the quality of data collected, which then, in turn, speeds up data cleaning and analysis? When clinical professionals are in the critical stage of starting up a clinical trial, have we simplified things for them? Have we removed steps in the start-up process? Have we made something simple that used to be feared-or simply wasn’t understood? The measure is a challenge for sure; if you can tie improvements to faster start-up timelines, you have a metric that everyone will relate to.
Q: It’s well discussed that the pharma industry does not quickly embrace change. How can people get more accepting of technological change in clinical trials?
What immediately comes to mind is how crucial it is that technology is built on a deep understanding of the business process it is enabling. When offering technical solutions in the clinical space where your customers are clinical experts, not software development experts, it is paramount that the software support their processes. In order to provide a compelling argument that the technology will improve their process/jobs/ time-to-patient impact, you have to demonstrate that you understand their processes and the challenges of their jobs.
This might sound simple but too often in this industry we see biotech and pharma organizations working their process around the system that they have and, inevitably, it doesn’t work as expected, or worse, there are quality issues. In an industry as regulated as ours, successful technology change must start with business expertise.
Q: There are clinical trial processes or areas that are ripe for technology innovation, which is how your company launched in the RTSM area. Do you see other processes that could be positively changed with new approaches?
Absolutely. As you’ve said, our industry has a reputation for being slow to change, especially in the technology area, and certainly there are opportunities across all aspects of clinical development that we could consider automating or improving. A few trends/areas that I’ve been especially interested in this year relate to clinical sites. I’ve been fortunate enough this year to work directly with clinical sites to get their input into our RTSM product, and I can’t stress how valuable that feedback is. Clinical sites, with tens of trials running at a time using multiple systems for each-all doing different things-layer onto that site processes that all must be followed independent of sponsor requirements.
After many years in the industry, it was truly eye-opening for me. One investigator, with about 30 years of experience, noted they had never been asked by a sponsor for feedback about the tools that they use. I think site engagement and communication related to clinical technology-both at start up and ongoing-is an area of deep possibility.
Editor’s note: Watch Christine Hurley discuss advances in clinical trial supply management on the ACT TV player on our homepage.