Sponsors of clinical trials must deal with growing amounts of data, generated by an average of six different sources during the planning and conduct phases. While many sponsors are getting away from spreadsheets and paper, the diverse ecosystem of data systems, financial software, patient-reported assessments, and mobile devices are only adding to the data complexity.
Good data governance practices require that sponsors manage both the integrity and agility of their data. Data integrity covers security and compliance concerns, while data agility involves issues surrounding availability and usability. Too often, the competition between these four pillars of data governance can damage the important work of clinical teams.
In our recent webinar about data governance, we asked attendees what aspect of data governance was most concerning to them. Compliance was by far the top choice at 64%, followed by usability at 21% and security at 14%. While no one cited data availability as a primary concern, it may be because sponsors are awash in data and think it’s available just by its mere existence. What makes data truly available, however, is the ability to visualize it, quickly report on it, and make informed, contextual decisions.
Figure 1. By a wide margin, webinar attendees named compliance as their most important data governance issue.
Nine Data Governance Principles to Support Your Clinical Trials
While our poll question gave us an interesting insight into what sponsors are thinking, it probably wasn’t completely fair to ask for a primary concern when all four aspects of data governance are intermingled. We recognize the fact that focusing too heavily on data integrity limits data agility, and vice versa.
So how can a sponsor strike the right data governance balance across all the phases of a clinical trial? In our webinar, my colleague Sean Svedja outlines nine best practices you can use to prevent integrity and agility issues from slowing down your trials.
In the conduct phase, for example, one of the most important things you can do is address security by moving data storage to the cloud. This will allow you to implement security protocols without restructuring data or changing your workflows.
Source data review compliance is another big issue in the conduct phase. One way to address this is by leveraging open data standards and metrics, like those laid out by the Metrics Champion Consortium. These can help inform your decision-making processes and keep your compliance checks from stalling.
Figure 2. Nine data governance principles can keep your trials at peak performance across every phase.
Make Data Unification the Cornerstone of Your Data Governance Initiative
In order to focus equally on data integrity and agility, it’s important to enable the free exchange of structured data between clinical systems so data can be entered once and used multiple times without manual re-entry. This requires a solution that can standardize data from all your different systems, sources, and vendors. For unstructured data, like patient-reported outcomes, special care must be taken in deciding what data is useful and how and when it should be gathered. Looking for certain keywords or phrases in patient responses, for example, is a governance practice that can save time during data review.
The goal for any clinical trial sponsor is to establish a centralized data management repository that enables high- and low-level performance views of studies, sites, and vendors; data standardization across systems; automatic updates in near real time; and the ability to aggregate data from the past, present, and future. Such a solution will empower you to strike the right balance between operational efficiency and rigor when it comes to security and compliance.
Figure 3. Data that’s aggregated and standardized for effective analytics and reporting can benefit every team involved in getting new medical treatments approved.
Until recent advances in data science, it has been next to impossible for sponsors to gain the agility they need to operate effectively while meeting increasingly stringent compliance and security requirements. It’s still prohibitive to take a DIY approach to unifying data for better data governance, but technology partners exist who can help you create a unified data pipeline that your teams, and your studies, can benefit from.
For more information on how Comprehend’s Clinical Intelligence Suite can improve your data integrity and agility, please watch our data governance webinar now. If you like what you see and want a trusted partner to help you implement proven data governance best practices, call Comprehend at 650-521-5449 or request a demo.
We’re Here for You!
Let us help you overcome your clinical trial challenges.