While paper and pen were perfectly adequate means of capturing clinical trial data in the past, the sheer scale and complexity of studies have increased to the point where this is no longer feasible. The obvious solution is implementing electronic data capture (EDC) into an electronic data capture system (EDCS).
The benefits are significant and include more efficient data capturing and faster processing, cleaner and more accurate data, as well as savings in time and money.
But before we explore the efficiency gains in greater detail, let’s look at what goes into making an effective electronic data capture system.
The Five Basic Requirements of an EDCS
Biometrics CRO Cytel writes that the basic anatomy of an EDCS can be distilled into five key considerations.
- Cost. This varies based on whether sponsors opt for licensing, subscriptions, pay-as-you-go or pay-per-protocol models.
- Operational concerns. The system needs to be powerful enough to deliver data according to trial protocol.
- Technical support. The system needs to be simple enough for the end user, and support must be in place should any modifications to the system be required or issues resolved.
- Ease of implementation. The level of knowledge and training requirements for those involved in using the system must be taken into consideration.
- Vendor stability. The vendor that supplied the system needs to be well established and consistent in service quality and pricing.
Every EDCS Needs To Meet These Core Functionalities
While there are many different types of electronic data capture systems on the market, each with unique offerings, Forte Research says there are certain core functionalities that have to be met.
One is the electronic case report form designer. Designed in the same format as commonly used paper forms, eCRFs eliminate the need to create new forms and ensure data standards are met.
Other functionalities include easy data entry and data export, along with built-in metrics for reporting. Additionally, the EDCS should be able to manage automated and manual queries among monitors, managers and coordinators.
What an EDCS Vendor Should Provide
Major EDCS providers have dominated the market for years, but consultant Phillip Strickland at Ennov writes that it is not necessary to limit your choice to just these providers. Reluctance to explore alternatives stems from the fact that many pharma/biotech/CRO companies find the task of choosing an EDCS provider rather complex and simply default to the most familiar.
However, Strickland says it’s not as daunting as it seems. The two factors to look for in an EDCS pertain to the vendor itself and the data capabilities.
First, it is important that trial sponsors have complete control over the EDCS and should avoid getting locked into agreements in which the system vendor needs to be called in regularly to update the system. This means that the trial team won’t waste time and money sorting out basic administrative rights.
It’s worth noting that most CROs do not have large IT teams and, therefore, opt for SaaS or cloud hosting models. While this is easier, it does lock them into long-term hosting contracts.
However, if companies do have internal systems with in-house IT skills and datacenter infrastructure, they should look for vendors that can accommodate on-premise hosting and SaaS or cloud solutions.
Secondly, and after vendor considerations, there are decisions about data capabilities. An EDCS, Strickland says, needs to grant “easy and instant access” to trial data. That data must be delivered in real time and in multiple formats, including online reports, Excel exports and SAS.
Connecting the EDCS
When it comes to EDCS software, OpenClinica explains that it is often web-based and uses “a thin client.”
In other words, the software runs on a web server similar to Google and users can rely on an ordinary web browser to access the EDC software. The results are more efficient data capture and analysis. OpenClinica says data is cleaner as edit checks can be programmed into the software to make data comply with designated formats and ranges before entering the trial database.
The EDCS can also help researchers in the trial by requesting specific data for particular patients at specific moments in the study. This means there is no excess or unnecessary data involved and smooths over any data discrepancies.
The web-based EDCS also means faster and real-time access to data, which facilitates rapid changes to the study should these be required.
Commercial, Open Source and In-House EDCS
Depending on the trial needs and the budgets of pharma companies, an EDCS can be commercial, open source or in-house developed. Techopedia adds that the EDCS could be “standalone, server based, or a multi-site, Web-based system.”
Each should offer the ability to streamline data, often across various devices and systems. Additionally, an EDCS needs to provide clear and easy-to-use data audit trails, and the ability to inspect data changes. This will help ensure easy and cost-effective compliance with regulations.
EDCS Gone Mobile
An advantage of building a mobile device-based EDCS (mEDCS) is ease of use, Thomas Beaton, editor at Xtelligent Healthcare Media, writes.
He says that when researchers from the George Institute of Global Health at Peking University Health Science Center developed a mEDCS, even doctors unfamiliar with using an EDCS found the process straightforward and easy to navigate. The mEDCS trial was implemented in 14 hospitals and accurately captured data from 1,037 patients, with 144 data entry questions completed by patients in an average of 53 minutes.
The doctors involved had historically transferred manually obtained data on paper records into an EDCS. With data collection, monitoring and project management in real time provided, the mEDCS saved doctors a lot of time.
Challenges That Arise When Using an EDCS
However, as with any tech, an EDCS is not without challenges. Interoperability between electronic medical records (EMRs) and EDCS can be an issue as the latter is not always designed to extract data from the former in an accurate manner.
The result is a challenge to process data from trial patients whose data is contained in incompatible EMRs.
According to a 2017 Tufts survey, most trial sponsors use 78 percent of their EDCS to run electronic case report form (eCRF) data. The problem with this is that it fails to offer a multi-dimensional view of the data, which is constantly increasing in scope and volume.
The report argues that there is a “need for EDC applications to better access and centralize clinical information” but adds that by 2020, 93 percent of respondents plan on using electronic patient reported outcomes (ePRO) and electronic clinical outcomes assessment (eCOA) as primary data sources.
An EDCS Makes Small Companies Mighty
A major empowering aspect of an EDCS is how it levels the playing field for companies. Previously affordable to big pharma companies only, the way an EDCS integrates with cloud technology provides smaller companies with “advanced and sophisticated solutions,” says Ale Gicqueau at software developer ClinCapture.
He regards the EDCS as a facilitator of a new kind of clinical trial in which retroactively tracking results allows researchers to spot patient safety issues sooner.
The result has been that smaller companies, through clinical trials analytics and electronic data capture, have been able to capture and analyze better quality data and, therefore, have greater success when submitting to the FDA.
Combine Your EDCS With a Strong Clinical Team
An EDCS works best when used by a trained clinical team, explains Carrie Cameron at Clinlogix. Having study coordinators well-trained in using an EDCS is a strong start as different studies are better suited by different EDC systems that all operate differently.
Cameron’s advice is to choose the EDCS based on the study protocol complexity; collect data for regulatory review and submission approval only; and have guidelines in place when filing the eCRF data into the EDCS. Finally, study coordinators should regularly interact with clinical data managers to resolve queries and review data in the EDCS.
Whether or not to use an EDCS is not really up for debate. With many models on the market, companies of any size can find a cost-effective solution that is easy to use. The gains in data efficiency and savings in time and money should convince any trial sponsor or coordinator to implement an EDCS immediately.
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