Clinical Data Management Solutions: Digital Source, Paper Source, or a Hybrid Approach?

Your Guide to Selecting the Right Clinical Data Management Solution

Researchers have a range of choices, and many reasons to consider them carefully.

Many people had thought data collection for clinical trials would be completely digital by now, but that’s just not the case. In fact, most trials still rely on some form of paper source data collection or include sites with limited connectivity. So, if your studies still include paper data collection, don’t worry. You are in good company. And there are many reasons for the continued use of paper. For one thing, the most advanced technology is not always the most appropriate. Paper is often the right choice for studies conducted in areas with limited connectivity, for instance.

Most trials still rely on some form of paper data collection or include sites with limited connectivity.

In a study comparing electronic and paper Case Report Forms (CRFs), the investigators’ findings suggested that eCRFs and pCRFs are options that complement each other and that each has its own indications. For example, investigators concluded that eCRFs were most effective in studies using larger numbers of patients and study centers, while pCRFs were more appropriate for smaller studies. The investigators wrote in their conclusion that the choice between paper and electronic CRF is a significant step in the design and execution of clinical studies “that should be discussed with the involved stakeholders and based on efficiency.”

COVID-19 As Agent of Change for Clinical Data Management.

COVID-19 has done a lot to move the world further down the path toward digitizing elements of clinical trials. Most researchers determined to continue their work during the pandemic arrived at a hybrid approach, retaining paper and in-person interactions where possible and pivoting to the digital and virtual where necessary. Where those changes have improved the experience of the trial for those involved, and/or the results, why look back? We won’t, according to Henry McNamara, GM and SVP of Oracle Health Sciences, in an article from Clinical Research News: “The shift to decentralized clinical trials and decentralized remote patient monitoring is not going away. The lockdowns of the COVID-19 pandemic had a major impact on clinical trials in 2020, leading to the rapid adoption of telemedicine and decentralized trial methods. The industry is not going back to ‘the old way.’ Therefore, sponsors and CROs need to set themselves up to operate successfully in this new model.” Commenting in the same article, Dan Vahdat, CEO and founder of Huma, noted that the digitalization of clinical trials enables researchers to “collect a lot more data, a lot more easily and from a lot more people.”

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.”

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Still, the Value of Paper Endures.

While the benefits of digitizing aspects of clinical trials are obvious, especially in the context of a global pandemic, so is the continuing importance of paper. To paraphrase an age-old adage, don’t throw out the baby with the bathwater. In fact, let’s remember that the trials that were able to continue despite the many challenges of COVID-19 were not entirely digital. They were hybrids. It’s vital to remember that quality data remains the ultimate goal of a clinical trial. In many cases that will still involve a paper element, and that is fine.

Get Connected. Be Informed.

Wherever your organization is today on the continuum between paper and digitalization, you need to be looking toward the future, however it might unfold. Get familiar with organizations and initiatives focused on building guidances and best practices for digital and hybrid clinical trials. The Clinical Trials Transformation Initiative is one such entity. See its guidance for the future of clinical research, “Transforming Trials 2030.” Certainly, you should also become as familiar as possible with the regulatory requirements regarding EDC systems. In the United States, they are contained in part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11). And get acquainted with important regulatory considerations related to electronic signature acceptance, privacy laws, and regulatory-compliant, traceable audit trails. In the EU, the European Medicines Agency provides oversight on electronic data capture.

You Have a Range of Options.

Wherever your organization is on the continuum between paper source and digital source, you can enjoy the fact that you have options for clinical data management. Today’s clinical trial might still be conducted entirely on paper, or it might be conducted electronically, via electronic data capture (EDC) or even direct data capture (DDC). There is also the option to conduct a hybrid trial. Let’s consider each of these scenarios in more detail:

The Paper-based Approach to Clinical Data Collection The paper-based trial is alive and well in the third decade of the 21^st century, although few thought that would be the case back in the 20^th century. Why choose paper in the digital age? There are several good reasons: Using EDC can mean duplicating efforts to some extent as the information is originally collected on paper and then must be entered into the electronic system. Many sites don’t want to take on the job of data entry. Why would a sponsor choose paper? To keep sites happy, especially highly experienced and productive sites. Something to the effect of paper IS the technology – there is no further technology to introduce or train.

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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.

Get the Support You Need to Transition with Ease.

Know that you don’t need to innovate solo. There are expert resources available to help you. We at DFnet, for example, successfully transitioned from paper to EDC ourselves several years ago. With that experience behind us, and our track record of creating more than 2 million clinical records for studies conducted in 35 countries, we are the perfect partner for a team that is ready to move to or expand its use of digital technology in clinical research. Turn to us for help with common questions and concerns like these:

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

On these subjects and many more, we are ready to help.

About DFnet

For more than 20 years, DFnet has offering tailored electronic data capture software and services to help research companies and organizations bring global trials to the world. To see for yourself how DFnet solutions can improve the speed and accuracy of your clinical trials, schedule a demo today.

FAQ

What does a hybrid paper-electronic approach to clinical data management look like?

“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

What does a hybrid paper-electronic approach to clinical data management look like?

“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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