The role that integrations play in decentralized clinical trials
EHR / medical data that already exists in the patient’s chart is becoming increasingly important, especially for decentralized clinical trials. Why? EHR data can provide access to patients that may not be geographically located near the site conducting the clinical trial. Also, integrations like this can save clinical researchers copious amounts of time traditionally spent transcribing data from the electronic health record (EHR) into the electronic data capture (EDC) system. This, plus other integrations such as wearables and telehealth technology are also explored in this guide.
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Each decentralized clinical trial is unique and has its own set of requirements and may require integrations between systems, such as:
- Remote patient monitoring: sensors, wearables, medical devices, and health apps Enabling outside sources to contribute valuable, accurate patient data into the EDC can save clinical trial stakeholders tons of time. Plus, it reduces the burden on patients. With virtually every person utilizing a smart device, integrating with them may be a huge benefit for your study.
- Telehealth technology: If you need to meet with patients but are not requiring that they visit a site, consider adding a telehealth component to your study. The COVID-19 pandemic greatly increased the number of appointments conducted over secure video conferencing, increasing patients’ confidence and affinity for this type of technology.
- Labs, IxRS, CTMS, EHR, payments: These are examples of technologies commonly used in clinical trials today that you may benefit from integrating into your study.
- APIs: The key to integration API (Application Programming Interface) refers to the modern technical interface software developers use to enable real-time interchange of data between systems. Not all APIs are created equal, however. They can be based on different technical standards, which can make them difficult or easy to work with. The APIs on each side of the integration need to have the right “hooks” available to support the use cases most important to you.
Leverage existing data from medical records (EHRs)
We all know that the source record for your clinical trial data matters a lot. We also know that it’s a real pain to have to track and manage source documents (especially paper ones!). The approaches mentioned earlier all enable your data to be electronically sourced. Such “eSourced” data means there is no separate source of the data in your study that must be manually reconciled and could introduce data quality risks.
Unfortunately, today, it is typical in clinical trials for research coordinators to manually transcribe data from the site’s system housing the patient’s health record (i.e., EHR system) into the EDC system. This, of course, is not eSource. The result is that your study’s source lives in the EHR, placing an enormous burden on the sponsor to ensure that what’s in the EDC system is consistent with what’s in the EHR.
Integrated EHR eSource
Consider the value that data from the patient’s chart pulled directly into your EDC could have on your clinical trial. Most sites must carve out considerable time and resources to transcribe EHR data into the EDC. Integrating directly with the EHR allows you to unlock latent data that sites would otherwise spend hours trying to input, data managers would spend hours cleaning, and sponsors might not be able to get their hands on for weeks or months.
Innovative technologies like OpenClinica Unite™ solve the problem of tracking and managing source documents by transferring data directly to your EDC system in a quick, reliable, and regulatory compliant manner.
EHR eSource benefits both sites and sponsors:
- Save countless hours expended by overburdened coordinators and clinicians. Reduce routine tasks from hours to seconds.
- Redirect attention to patient safety and care as opposed to data processing.
- Participate in research more easily and profitably.
- Obtain higher quality data that is cleaner and more complete.
- Get access to finalized study data faster.
- Reduce the costly practice of 100% SDV.
- Increase site satisfaction and compliance.
Learn more about OpenClinica Unite, an EHR eSource integration solution >>
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).