A knee-jerk reaction to the technology would keep pharma from its benefits.
Cloud technology opens up the potential for exciting innovations when it comes to the design and execution of clinical trials, but data security and privacy concerns are holding innovation at a snail’s pace.
Despite these misgivings, cloud-based solutions could in fact offer greater security, as well as the ability to access large pools of data that would improve an organization’s ability to find the right volunteers.
“When we originally started looking at the cloud, most regulators had the ‘cloud is bad’ mentality — you shouldn’t put medical data in the cloud, period,” Jonathan Armstrong, a technology and compliance lawyer at London-based legal services firm Cordery, told MobiHealthNews. “It’s not as binary as that.”
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He pointed out that for a small company doing clinical trials, the cloud may in fact be more secure and more likely to protect sensitive data because it’s not on someone’s personal laptop. Further, it could allow pharmaceutical companies to use that data more proportionately.
“If it’s a critical trial, that company could use a platform that would suit anonymized data more rapidly,” he explained. “If that cloud-based app is structured correctly, it’s less likely someone can ID the individual, because the software can help us use anonymizing techniques more efficiently.”
Pharmaceutical companies are very complex organizations in respect to their info and data needs. And for those involved in clinical research, a lot of information is collected about individuals, much of it extraordinarily sensitive.
“Every application is going to be different, and people are putting a lot of thought into the use of cloud,” he said. “But you’ve got to plan privacy data into that equation.”
Dr. Abed Saif, founding partner and director of cybersecurity advisory services specialist AbedGraham, noted there are a number of ways the cloud can help drive innovation when it comes to clinical trials, depending on the perspective you want to take.
“If the transition to the cloud is well executed, it can open up development options and enhanced computing power that organizations can utilize to develop a range of digital solutions,” he told MobiHealthNews.
These include the ability to enhance the identification, selection, onboarding and monitoring of patients that are considered eligible for clinical trials.
“Pharmaceutical companies are so slow with this — using the cloud to share information,” Dr. Larry Ponemon, chairman and founder of the Ponemon Institute, told MobiHealthNews. “A clinical is about getting people who are willing to participate — say you want to recruit people who have a certain disease — and this requires sharing different clinical trial data; a meta-anaylsis of more than one study.”
Cloud-based technologies would allows these companies to more easily bring together actual patients who want to volunteer their lives, Ponemon said while noting that cloud could help with recruiting and identifying doctors and researchers working in the right areas.
He pointed to the “right to try” laws in the US, which give people with deadly diseases the ability to try a new drug before it’s been approved.
“Cloud-based research and patient matching technologies would provide an opportunity to reach out to people who are eligible for this right to try program,” he said. “We want pharmaceutical companies to use the cloud to innovate with clinical trials, but the security concerns are still there.”
Date: July 07, 2019