Clinical data management
Rise to the
ur biggest competitor is paper,” Andrea Bastek, director of innovation at Florence Healthcare, tells me. “I speak to software developers all the time who say [this],” she explains, “and I talk to people in the clinical trial space [who] say, ‘paper works great.’” Only, as Bastek well knows, it doesn’t. Running through a hospital, paper in hand, trying to track down a doctor for a wet-ink signature is hardly an efficient way of working. Nor is archiving medical records in rooms full of ring-binders or sending trial monitors halfway across the world to check on something they could just as easily have seen on a video call.
“O 30
challenge
Running a clinical trial can be a diffi cult process at the best of times, but the level of complexity can be orders of magnitude higher when it comes to rare disease research. Technology can help overcome some challenges, but are there methods out there that could lead to a paradigm shift for the better? Mae Losasso asks Andrea Bastek, director of innovation at Florence Healthcare, and
Sir Mark Caulfi eld, professor of Clinical Pharmacology at the William Harvey Research Institute in Queen Mary University of London and a primary investigator on the ‘100,000 Genomes Pilot on Rare-Disease Diagnosis in Health Care – Preliminary Report’.
“The goal is for clinical trials to go faster and be more efficient, so that we get new drugs and devices to patients and medical professionals as fast as possible,” Bastek explains. “[But] there are a lot of things standing in the way of that goal.” Many of these challenges are related to time expenditure, like the time to develop a protocol, get regulatory approval and funding to run the trial, as well as selecting sites that have the right patient population and expertise. But there’s also the issue of recruiting the patients themselves and keeping them onboard so that the data is complete. As if these constraints weren’t enough, clinical trials are also faced with “overarching issues of
Clinical Trials Insight /
www.worldpharmaceuticals.net
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Shutterstock.com
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