Clinical Data Management Solutions: Digital Source, Paper Source, or a Hybrid Approach?
Most trials still rely on some form of paper data collection or include sites with limited connectivity.
Digitalization of clinical trials enables researchers to collect a lot more data, a lot more easily, and from a lot more people.
Finally, Henry Levy, general manager, Vault CDMS, site, and patient solutions at Veeva Systems, spoke to his conviction that paperless, patient-centric trials will ultimately become the norm: “Getting participants to finish a clinical trial is not easy because of the heavy burden placed on patients. In 2019, dropout rates rose to 19.1% in late-stage studies globally from 15.3% in 2012. COVID disruptions and restrictions accelerated change in how trials are run as the industry looks to end its reliance on paper. To reduce the patient burden and modernize studies, paperless, patient-centric trials will be a top priority for life sciences companies in 2021.”Let DFnet help you build a better relationship with your clinical data. Contact us to get started.
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The Digital Approach to Clinical Data Collection
A “digital clinical trial” is one that leverages digital technology to improve participant access, engagement, trial-related measurements, and/or interventions, enable concealed randomized intervention allocation, and has the potential to transform clinical trials and to lower their cost, according to a 2020 article from Nature Partner Journals. Many thought leaders continue to state that the digital trial will ultimately be a paperless trial, but that day has not yet arrived, certainly not for global trials.
“In a single institutional setting where all of the sites are directly within your domain, a fully EDC or DDC, fully electronic trial is possible,” says Eric Bosch, Director of Software Development at DFnet. “But as soon as you start going out to other institutions, other countries, or other continents, a fully electronic trial is not going to work, not in all locations, not in 2021.”
For the time being, most elements of a clinical trial can, however, be cherry-picked as needed to enhance what is today by far the most common type of clinical trial, the hybrid.
The Hybrid Approach to Clinical Data Collection
Hybrid data management can mean a few different things: It could mean that for all clinical sites, some data collection forms are completed electronically and some are completed on paper. Or, it could mean that some clinical sites do EDC only while some do paper only. Another possibility is that paper forms are available as a backup in case of power/internet outage, usually where the CDMS is the data source and the site doesn’t have anywhere else to record data if there’s no internet.
What other reasons are there for a hybrid approach?
If the trial includes multiple sites, it’s often best to work with the system that meets each site’s needs, whether that is paper or digital. That can vary for many reasons, including the country and the technical infrastructure.
Where sites want to continue capturing data on paper, a hybrid approach would be for a partner like DFnet to customize the paper for the site, scan it, and do the data entry for the site. This also saves monitors the trouble of going to the site to review the paper, because the paper has been scanned into the DFnet system.
Why would a sponsor or CRO choose a hybrid approach? Maybe the study has already started on paper or the sites are not comfortable with technology. Maybe the participants are not tech savvy. Often, patient-completed questionnaires or other non-CRF data (lab results, pathology results, etc.) must be submitted via paper, but the actual CRFs can be completed electronically.
Keep in mind, too, that EDC platforms vary and sites that have used one may be asked to use a different platform in future trials. In such cases, they may push back and insist on paper, because that they know how to do, that remains the same from trial to trial.
Finally, the hybrid approach is a great way for sponsors and sites to venture into the digital world without committing entirely.
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You Can Innovate One Step at a Time. While paper-based and hybrid trials remain valid options, don’t hesitate to embrace digital where it makes sense. Remember, too, that you don’t need to go digital all at once. A manageable approach is to start with just one technology, such as electronic informed consent (eConsent). This digital solution streamlines the entire consent process, can support large portfolios, and enables decentralized studies. It can readily be the single digital element in what is otherwise a paper-based trial. Once comfortable with that, you might add an eDiary/ePRO to facilitate the collection of participants’ experiences. You can continue on at the pace that works for you from there.- Best practices for paper-based trials in a digital world
- Migrating from a paper-based form to an electronic consent process
- How to migrate from paper CRFs to electronic CRFs
- How to add eConsent and ePRO/eCOA to a traditional trial
- Best practices for managing global eConsent/reconsent for paper, digital, or hybrid trials
- Sensible approaches to compliant adoption of remote consenting and telemedicine
FAQ
“Hybrid data management can mean a few different things: It could mean that for all clinical sites some data collection forms are completed electronically and some are completed on paper. Or, it could mean that some clinical sites do EDC only while some use paper. Another possibility is that paper forms are available as a backup only in case of power or internet outage, usually where the CDMS collects source data and the site doesn’t have anywhere else to record data if there’s no internet.”
- Laura Joldersma, Clinical Data Management Specialist at DFnet
“Our hybrid approach lets the data tell the story and does not force a specific technology on the data. In effect, hybrid is data-centric and not solution-centric. If it makes sense to collect data on paper, or it is already on paper, then leave it there. A hybrid approach recognizes that the data is the end goal, not the technology.”
- Eric Bosch, Director of Software Development at DFnet
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Clinical Data Management Solutions: Digital Source, Paper Source, or a Hybrid Approach?
A guide to understanding the types of solutions available, determining what is right for your clinical study, and getting the support you need to ensure high-quality clinical data.
