A checklist for ensuring your decentralized clinical trial can report on and analyze its clinical data
The following checklist offers considerations for reporting, analysis, and insights of your clinical data, helping to accelerate your move to decentralization.
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Actionable intelligence via reports and dashboards
With all your data collection components in place, you’ll need to consider how you will track study progress and identify possible issues. Good reporting is especially important in a decentralized trial because you’ll be relying less on sites to help ensure things are happening in the right way. So, start by developing a list of key metrics that will matter. These could be organized into different categories, such as:
- Safety (e.g., relationships between treatment and AEs)
- Protocol compliance (e.g., number of events out of window)
- Recruitment (e.g., screen failure rate)
- Data cleaning (e.g., query resolution rate)
While you should start out with a target set of metrics, it’s nearly impossible to predict what you might want to analyze as the study progresses. Therefore, it’s important to have a flexible analytics toolset that gives you access to slice, dice, and visualize all your clinical data and metadata.
Things to consider when planning your reporting needs:
- Make sure you have immediate access to operational and clinical data (so team members can act quickly on everything from queries to adverse events). It should also be easy to access the data underlying a given report.
- Set-up different dashboards (collection of reports) around different themes and/or specific dashboards for specific stakeholder groups containing the set of reports most relevant to that stakeholder.
- Assign permissions to ensure you maintain appropriate confidentiality and enable users to access the reports they need to do their job.
- What’s the best way to compare performance, trends, patterns, and outliers by cohorts? Be sure you’re able to visualize a given set of data in flexible ways (e.g., via bar charts, scatter plots, stacked line graphs, goal lines, data tables, etc.).
- To ensure your reports are as actionable as possible, they should be able to push alerts and updates automatically to relevant stakeholders.
- The system should be easy enough to use so that you can quickly create new reports, update existing ones, and enable your colleagues to build their own reports without requiring specialized technical skills.
What a good reporting solution can do for your trial stakeholders:
- Data Managers, Monitors, Sites, and Sponsors: Historically these stakeholders have relied on Excel spreadsheets as the glue to fill in the gaps of rigid reporting systems. However, sites, monitors, data managers, and sponsors can now perform all their reporting in a collaborative manner online. This makes it easy to share and reuse reports resulting in better communication, organization, and faster decision making.
- Statisticians: Statisticians are responsible for ensuring that the study is constructed in a way that will help the sponsor draw conclusions from the trial data. They focus on the questions the study needs to answer. A system that makes it easy for statisticians to understand and navigate the data, and provides flexible tools for interpreting this data, enables statisticians to maximize the value they deliver in their essential role.
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How to pick the right partner for your hybrid trial
There are 4 key factors to consider when evaluating technology partners for your decentralized clinical trial.
- Software: Write down and prioritize your requirements to serve as a “shopping list.” But keep in mind that while it’s important to check off a certain number of requirement boxes, it’s also important to realize that the toolset itself isn’t the sole determinant of a successful trial. Just because you have a box full of hammers, saws, and wrenches, doesn’t mean you’ll be able to build a house. How reliable is the system? Can the features you need sufficiently scale and adapt? Evaluating ease-of-use is particularly difficult to distill into written requirements. Ask the vendor you’re considering to provide a sandbox where you and your team members can get hands-on with the software.
- Support: Every clinical study requires a certain level of support when it comes to onboarding new technology. How long does implementation take? What skills and resources are required? What does training look like? You’ll need more than just responsive tech support. Your vendor should also make it easy to demonstrate ongoing compliance with regulations such as ICH GCP, 21 CFR Part 11, HIPAA, and GDPR.
- Professional Services: Most technology companies offer a variety of professional services, but make sure you investigate the availability and expertise of the support personnel that will be the key to your success. Believe it or not, some vendors hire and train people with very little industry experience. Search for a partner that hires people with field experience, such as former clinical data managers or clinical research coordinators. You’re bound to have a much better experience by working with a company whose people understand what it’s like to be in your shoes.
- Cost: Cost is always a critical factor. Consider not just the direct cost of the software, but how other costs may be impacted as well (such as data entry/cleaning costs, monitoring costs, site payments, etc.). The correct way to assess costs is to look at them holistically.
OpenClinica: The partner you can count on to drive the future of your digital clinical trials
OpenClinica is available to help you with all your decentralized clinical trial needs. We pride ourselves on making the complex easy. Our eClinical platform is the product of more than 15 years of refinement and input from our community of clinical data managers, researchers, study participants, and other clinical trial stakeholders.
We obsess over user experience. We believe that electronic data capture shouldn’t be difficult or require specialized expertise to implement. For these reasons, we’ve worked hard to make our platform easy to adopt so that you can stay focused on what matters most: your clinical research and the advancement of healthcare for patients that live happier, healthier lives. Plus, our support staff is here to help you in whatever ways you need.
In today’s increasingly virtual world, we can help you bring innovative, immersive experiences to life for your clinical research. The end result? Better data, faster.
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Driving the future of digital clinical trials
OpenClinica is transforming healthcare through innovative cloud technology that simplifies running clinical trials. Proven in over 10,000 trials worldwide, the OpenClinica platform is trusted by leading biopharmaceutical companies, contract research organizations, academic institutions, and government agencies.
OpenClinica is used across a wide spectrum of clinical research, including drug, device, and diagnostic trials, global health studies involving over 2 million patients, adaptive platform trials, and clinical trials for some of the first gene therapies to be approved for market. Hundreds of small, midsize, and large research teams leverage OpenClinica to capture better clinical data faster, and to do so in a way that meets the highest standards for security and regulatory compliance (ICH GCP, 21 CFR Part 11, GDPR, HIPAA).