When we talk with sponsors, the vast majority of them say that data integration across clinical trial applications—EDC, CTMS, ePRO, IxRS, labs, safety, etc.—is the one thing that would most benefit their teams. Clinical trial data unification is a key springboard for numerous improvements that can help sponsors complete trials in a timely manner, with a better chance at approval.
With the overall clinical trial approval rate in the mid teens, it’s important to note that about half of study rejections are due to controllable factors, such as poor data quality and inferior audit readiness. It’s one thing for a trial to be denied because a drug or device doesn’t work, but quite another when a rejection comes from data issues that could have been prevented. In such cases, the pain of the lost investment, missed revenue potential, and the failure to treat patients is even more acute.
Comprehend’s experience using data science to deliver better transparency, collaboration, and oversight capabilities for sponsors has helped us determine five important improvement opportunities that you can take advantage of when your clinical trial data is unified into a standard data model. Here’s a quick explanation of each one:
1. Issue Identification—Closing Operational Gaps
With a centralized data depository, or a single source of truth as we like to call it, missing data, problematic data, and other issues—by study, site, CRO, visit, subject, etc.—can bubble up to the surface much faster than they can via team meetings or manually going through spreadsheets.
2. Actionable insights—Responding to Every Situation
When data is properly integrated and standardized, you can drill down to determine root cause, run what-if scenarios, and set automated alerts that notify you when key metrics are falling short of plan. The ability to analyze trends and anomalies in context can reveal correct action and speed your trials to better results.
3. Faster Issue Resolution—Leveraging the Right Solutions
Once issues are identified and made actionable, the right people must be notified, assigned tasks, and have a system in place to document the entire resolution process. Unifying your operational and clinical data enables the analytics that drive decisions, with data governance processes built right in.
4. Real-Time Communication and Transparency—Achieving Compliance
Unified data aligns every stakeholder and makes it easier to establish priorities that can streamline workflows and focus attention where it’s needed. Replacing emails, voicemails, and meetings with documented processes is a huge opportunity that allows accountability to take root across your study teams.
5. Audit Readiness—Getting to Yes
Being able to tell the story of your trials, with data and proper documentation at all times, can help ensure adherence to mandatory regulations, guidelines, CRO plans, and other rules that allow for more seamless data audits. Automated, real-time data views and reports at the site, CRA, subject, CRO, study, and portfolio levels will enable you to document the who, what, and why of every action taken.
In a recent webinar, Capturing the Value of Clinical Trial Intelligence, we asked attendees which of the five improvement areas would bring the most benefit to their organization or team. As you can see in the graphic above, the results were pretty even across the board, with Faster Issue Resolution just edging out the others.
I believe that the results are so evenly spread out because it’s really difficult to isolate one of the improvement opportunities. For sponsors today, all of them are important and contribute to getting trials completed faster and more successfully.
Why Isn’t Everyone Unifying Their Data?
We know that most sponsors and CROs want unified data, and we know that such action aligns with ICH E6(R2) guidance for adopting data-driven approaches to quality management and clinical trial monitoring.
So why isn’t everyone doing it? The short answer is that integrating data and reporting across applications create big challenges, which only increase with a greater number of systems used. If you use three or more data systems, as most sponsors do, then it can become somewhat of a logistical nightmare to bring everything together.
Fortunately, however, sponsors don’t have to go it alone. With solutions like Comprehend’s Clinical Intelligence Suite, you can be up and running with unified data in a matter of weeks. In our work with sponsors, we’ve seen the benefit of setting up implementations as a series of “quick wins.” This is a great way to manage change and get users to buy into a more data-driven paradigm. In addition, documenting goals and results throughout the implementation process, including screenshots, actions taken, and lessons learned, gives you a valuable document you can use for training and onboarding.
When you look for a solution that unifies your clinical trial data, be sure that it offers the following features:
- SaaS-Based
No capital expense or on-site installation costs. - Pre-Packaged Convenience
Faster to deploy than custom developments. Purpose-built data connectors, reporting capabilities, and role-based dashboards enable new trials to get started fast, on a single, stable platform. - Scalable Cost Structure
Pay by the trial, and scale for different study sizes and phases. - No IT Admin Costs
Users should be able to create their own reports, run their own investigations and queries, and ask what-if questions.
For more information on how Comprehend can help you exploit the five opportunities for better clinical trial outcomes, please watch our clinical intelligence webinar now. If you want to capture the value of clinical trial intelligence right away, please call us at 650-521-5449 or request a demo.
