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Volume 40, Issue 3
Amid concerns over a potential 'wild west' climate for data analytics in pharma, taking a long-term, proactive, and enterprise view of your company’s data may be the best way to keep your organization and reputation safe.
We’ve seen the signs. Cambridge Analytica. Facebook. Even Ring-recently, the app and service that customers use to manage and control the Ring camera is sending personal data around in a seemingly public, not monitored or customer-acknowledged use of data.1 The bumpy ride of data in the consumer world has not gone unnoticed in pharma. Where this conservative industry may have the one-up on everyone else, is
exactly that conservatism. A penchant for compliance, an almost religious aversion to anything that might go afoul of FDA guidance and regulation (at least in drug submissions), and a need to follow SOPs at any and all levels-may actually help pharma, not hurt it.
Consumer concerns around data privacy were highlighted in a recent report2, which found that approximately 97% of consumers are somewhat or very concerned about protecting their data, but the majority don’t have the time or prowess to educate themselves. A further 91% want state or federal government to adopt strict regulations to protect their data; 43% of consumers would provide detailed data about themselves to a brand for a discount, and another 32% would for an exclusive benefit; and 72% said they would more likely read consumer-facing legal and policy agreements if they were shorter, and 61% would if they were more straightforward.
As I sat in a session on a Clinical Data Innovation at SCOPE (Summit for Clinical Operations Executives, held in February), it was clear that the executive leader from a large pharma presenting takes data to heart and he believes that any data breach that is publicized in the mainstream media has definitely hit the conscious of, at the very least, clinical trial participants. He suggested that maybe it is causing them to be more anxious about signing over their data in a clinical trial. They may ask themselves, what happens to my data? Who has access? As this executive said, “The concern may be unfounded, but it’s there.”
Further, there is an inherent trade-off between innovation and risk. The speaker said, “analytics could turn into the ‘wild west,’ where we risk doing things with data that we shouldn’t.” And not just at the clinical trial level; he views all data as an enterprise issue and one that pharmaceutical leaders should be honestly assessing.
Also in the big picture is the concept of individual data ownership. There is a lot of talk about data ownership and people being compensated for the use of their data “and we should think about that,” suggested the expert speaker.
To combat the possibility of a wild west analytics climate, he suggested that before anyone gets involved in data analysis for secondary purposes that it should be deemed appropriate and vetted by the right professionals at your organization.
And finally, the idea that any one functional area owns the data collected for its purposes is not valid. As the speaker stressed, “Enterprise owns the data. And technology that is put in place should structure the use of that data.”
Here are some recent Pharm Exec articles that discuss data, privacy, and security in pharma:
In the meantime, taking a long-term, proactive, enterprise view of your company’s data may be the best way to keep your organization and reputation safe.