IDBS Blogpharma regulation approves of knowledge management systems

IDBS Blog | 23rd April 2018

Knowledge Management Systems: Now FDA Approved?

“But I want to highlight one initiative, in particular: our efforts to build a knowledge management platform as part of our drug and medical device review programs.” – Scott Gottlieb, FDA Commissioner

In light of Scott Gottlieb’s announcement before Congress that the FDA is seeking funding for an electronic-based federal knowledge management system as part of its efforts to modernize, we delve into the importance of these platforms.

The collected experience of the FDA’s medical staff is immense. Building such a platform will not only allow the FDA to store and manage their findings across multiple functions, but allow every finding and scientific review precedent to be captured and stored on a daily basis, as a treasure trove of insight able to be searched and leveraged across the agency, in the years to come.

The FDA’s proposed initiative shouldn’t come as a shock: collaboration and connectivity is now more important than ever in the drug development and delivery world and other industries. It shouldn’t come as a surprise even government agencies like the FDA are looking to these practices for help. Using technology like an Electronic Laboratory Notebook (ELN), a knowledge management system will enable FDA staff to search for particular decisions made previously, understand the process of how those decisions were made,  and leverage this knowledge across their organization exactly like an ELN.

The problems the FDA are encountering aren’t uncommon. When Gottlieb says “we can’t store and interrogate the scientific precedent we establish every day,” he could be talking about the difficulty of capturing, managing, and leveraging the depth of knowledge their agency has gained over the years across the review process to responsibly and confidently approve life improving and saving drugs to market.

Given the scope of the FDA’s review-based work, it would simply be impossible to store and interrogate the scientific precedents established daily using a paper-based system. With the adoption and implementation of a digitized knowledge management system, the FDA will now be able to revolutionize the way its knowledge is stored and used for decades to come, allowing them to tap into the wealth of information and experience accumulated by their thousands of staff.

In his comments to Congress, Gottlieb summarizes the benefits of an electronic system nicely: “This platform would enable us to store and manage the collected experience of our medical review staff – to have a way to identify how decisions are made across different functions, the scientific precedents we establish in the course of our review process, and the knowledge we develop.”

“This sort of knowledge management system is essential to how we’re modernizing medical product review programs and the scientific precedents established every day.”

While the use of data and knowledge management systems like ELNs are already an accepted, but not necessarily fully adopted, tool in the private drug and clinical development sectors, their adoption by the FDA is a welcome addition as a recognition to their value, and one that could hugely streamline the drug development and delivery pathway as a whole.

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