An electronic data capture (EDC) platform is an essential tool for clinical trials. EDC software systems sort, clean and present data accurately and efficiently. These systems can save time and protect the quality of the research. In many ways, they are the future of clinical research.
There are many such tools on the market — and not all of them have optimal features. If your organization invests in a system that doesn’t perform, your team could be held back or you could lose time and money during another software transition.
Consider the needs of your team and the patient users of your therapies. Here are five key features that you should look for in an EDC platform.
1. Cloud Functionality
The clinical trial field is starting to explore the power of cloud data and what it means for security and data sharing. Admittedly, the healthcare field was wary of cloud functionality at first, but more regulators, researchers, and pharmaceutical organizations are realizing the benefits of this storage and sharing system.
“When we originally started looking at the cloud, most regulators had the 'cloud is bad' mentality — you shouldn’t put medical data in the cloud, period,” says U.K. lawyer and co-author of “Managing Risk: Technology and Communications,” Jonathan Armstrong. “It’s not as binary as that…If that cloud-based app is structured correctly, it’s less likely someone can ID the individual, because the software can help us use anonymizing techniques more efficiently.”
Even as regulators approve cloud storage options and encourage companies to invest in these systems, some organizations are still wary of making the transition. So far, internal server-based on-prem storage systems have proved secure, despite limited sharing capabilities.
As more healthcare cloud service tools hit the market, entrepreneurs are developing better tools to protect patient identification data. The demand for secure health data continues to rise, and EDC system creators are responding to their customer needs.
As you research EDC platforms, ask about the cloud functionality and security features. Learn how you can upload and share data while protecting it from hackers.
2. Data Cleaning
The COVID-19 pandemic might further drive companies to embrace EDC platforms. As clinical trials continue to become more remote and researchers meet fewer patients in person, teams need to ensure data still gets collected, sorted and cleaned.
Data sources need to be filtered and organized, then presented in clear reports that prove the value of the treatment option or new medication choice.
“Data collected may have errors that arise from multiple sources—data manually entered in a [case report form] may have typographical errors, whereas data obtained from data warehouses or administrative databases may have missing data, implausible values, and nonrandom misclassification errors,” explain Miren B. Dhudasia, Robert W. Grundmeier, and Sagori Mukhopadhyay, all from the Children’s Hospital of Philadelphia. “Having a systematic approach to identify and rectify these errors, while maintaining a log of the steps performed in the process, can prevent many roadblocks during analysis.”
An EDC system with data cleaning features can identify outliers or issues with sets of data. This allows the technicians to review the information to see if it needs to be corrected or if some data points need to be removed from the full set.
3. Remote Verification
Along with data cleaning, clinical researchers need to verify the accuracy of the data and the protected patient information. The use of remote information and digital tools is also on the rise because of the pandemic.
Michael Mezher, senior editor at the Regulatory Affairs Professionals Society, highlights changes to EU guidelines related to clinical trials held during the COVID-19 pandemic. Previously, researchers could only use remote source data verification (rSDV) in the final data cleaning steps, and it would only be approved in limited circumstances. Now, trial leaders can use rSDV for a variety of data needs, including on-site, centralized and off-site monitoring.
As remote data verification proves its value, more regulators feel comfortable using this method. The use of rSDV now may pave the way for expanded usage in future non-emergency trials.
“Data may be messy, but it’s due to the process, not the data itself,” says Nechama Katan, data science lead at Pfizer. “If we can control the process, we can control the data. That doesn’t mean trying to control every little step, but to control the big picture.”
With an EDC platform, your organization will have clean and verified data, ensuring better clinical reporting that proves your results.
4. Electronic Medical Record Integration
One major data source that clinical trial leaders rely on is electronic medical records (EMRs). When these are integrated with EDC tools, researchers can better sync the information with data collected throughout the trial.
“With modern health systems, it’s possible to capture a lot more information about how medicines are taken by patients and the effects they have on patients,” says Brendan Barnes, director of IP and data protection at the European Federation of Pharmaceutical Industries and Associations. “This really transforms the whole way that we do medicines research and development.”
Some medical experts are calling for changes to EMRs. They want better data that paints a clear picture of the patient and lays a path forward for treatment.
“An overhaul of the electronic health record is overdue,” says John Glaser, executive in residence for Harvard Medical School Executive Education. “The electronic health record must transition from an emphasis on a person’s medical record to an emphasis on a person’s plan for health and from a focus on supporting clinical transactions to a focus on delivering information to the provider and the patient.”
This process is not unique to clinical trial leaders and healthcare providers. The software industry as a whole continues to make strides for better, more intuitive technology that its users can easily adopt.
“Any time you change technology, you tend to change the whole work system to some extent,” says Daniel Morrow, professor of educational psychology at the University of Illinois Urbana-Champaign, in regard to his research on the adoption of Electronic Health Records. “It’s important to take a user-centered approach to designing these systems and have users’ perspectives in mind so you can forecast how their work processes will change.”
5. Report Customization
Once the data is collected, cleaned and reviewed, researchers can present their findings for FDA approval and eventual distribution. EDC platforms can also help with this process, because researchers can create customized reports that highlight tiered results.
“Electronic data capture systems used in clinical studies commonly feature a wide range of report types, with several relevant reports for various roles,” says Maëva Roques, clinical trial leader at Canadian oncology CRO Scimega. “The effort invested by clinical operations team members to familiarize themselves with pertinent report functions is time well spent.”
The reports generated and reviewed will be an essential part of the clinical study report (CSR). They can provide detailed information showcasing the results and add context to the work that researchers set out to do.
Sheryl Stewart at medical device provider Edwards Services, emphasizes the importance of data and key messaging in CSRs. She explains that both the International Council for Harmonization and the FDA have templates for creating CSRs but researchers are not required to stick with them. If they can create better explanations and discussions with an EDC platform, then their reports can hold more value.
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