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For years now, there’s been lots of discussion about electronic source (eSource) and its potential to transform clinical trial processes. The shift from an environment in which what is currently considered “source data” – essentially a combination of paper and electronic data recorded at the point of generation – to a future state in which data is only initially recorded in electronic format is already increasing efficiencies in clinical trials, enabling faster access to research data and more rapid decision making.
While eSource is here to stay, its adoption in clinical trials has been fragmented and slow, particularly among resource-constrained emerging biotech and biopharma startups. Understandably, among them, concerns include a range of different potential challenges, including those related to regulatory compliance, technology barriers and costs of change management. These concerns, however, should be considered in the context of the success of early adopters and growing interest and support from the FDA.
Innovative new technologies and increasing access to them are enabling exciting opportunities to collect higher quality data more quickly than ever before. These technologies have enhanced speed, efficiency and data quality for clinical trial sponsors and their CRO partners, eliminating the burdens of paper-based data management. And now, eSource is bringing these benefits to the site level.
Still, implementing and scaling eSource is a daunting challenge. It can, however, be managed with the right strategy and framework, even by smaller companies with limited budgets and less experience. What’s important is to understand the process of moving to a more electronic process in data capture does not need to be an “all-or-nothing” approach.
Below are questions that frequently come up in our discussions with startups and emerging biotechs. We hope the responses provided will be helpful in guiding discussions on eSource and how to navigate its adoption.
How should we define eSource?
Source documentation, according to the FDA, is the initial documentation of data within a clinical study.For example, source data may include initial blood pressure, height, weight and temperature recordings. Throughout the clinical trial process, integrity is then maintained by using an audit trail to track any changes or modifications that may occur to these recordings.
eSource is the digitization of this process. Instead of recording source data manually and then later transferring this data to an online data base, eSource captures data electronically from the start, directly into an CDMS (clinical data management system). With eSource, all source data must be electronic and must be followed with a detailed electronic audit trail.
What is the difference between eSource and eCOA (and ePRO)?
Simply put, eCOA (electronic Clinical Outcome Assessment) is a type of eSource, a method of capturing data electronically in clinical trials, and ePRO (electronic Patient Recorded Outcomes) is a type of eCOA. ePROs and other forms of ECOA use handheld devices, tablets and the web to enable patients, clinicians and caregivers to directly report outcomes, resulting in more granular endpoint data.
Beyond those focused on clinical trial sites, what benefits does eSource offer?
eSource has huge cost and time-saving implications for clinical trial stakeholders across the industry and sponsors of all sizes. For starters, using eSource results in greatly reducing the need for paper storage, source data verification (SDV) and travel among clinical trial site monitors. Utilizing eSource also lends itself to improving data integrity by allowing direct data flow from the source to the sponsor’s system, with minimal or no human intervention. Furthermore, by enabling real-time remote data sharing, eSource facilitates collaboration among trial stakeholders and across geographic barriers.
Does eSource Replace EDC?
It depends on how clinical trial sites capture study data. Electronic data capture (EDC) is used when sites capture data on paper source forms and then transcribe the data into a database. eSource is used when the site’s paper process is replaced by electronic capture of patient data. For example, when data is entered directly into a tablet and paper is not used to capture information.
If a company decides to only capture source data electronically, directly into a database, then, yes, eSource can replace EDC. However, if only few components of source data are captured electronically (for example, only patient feedback forms) and the majority of patient visit data are still captured on paper (and then transcribed into a database), a company can still use an EDC database and integrate the electronic source data into the EDC database.
Similarly, if the majority of data will be directly entered, electronically, into an eSource database, but one or two components may need to be manually transcribed (for example, a specific evaluation score or laboratory result), then an eSource database can be used. Those specific transcribed forms can be labelled “transcribed forms” andmanaged as such by the clinical team.
What are the pros and cons of adopting eSource?
Experience has shown us that the advantages of using eSource include high-quality data with less queries and no entry delays, and real-time access to insights that enable more informed decision making. However, experience has also shown us that the change management process can be challenging, especially because of how deeply embedded paper processes are in most companies’ SOPs. Proper planning and monitoring of eSource adoption is critical, particularly for site documentation management and clinical monitoring teams. It’s important to ensure necessary changes are being made and, for example, remote monitoring is taking place and source document verification (SDV) is reduced where possible.
While change management is often associated with increased costs, the transition to eSource can be done cost effectively. Forming partnerships with the right service providers, who can provide training on eSource data capture and the associated change management processes is also a key factor to enabling success.
What’s the best way to get started with eSource?
We highly recommend identifying service providers with the right experience, who can be true partners and support you in developing a strategy that fits your needs and through the change management process. We have also found that learning more about different eSource technology platforms is helpful. Requesting demos from various service providers is a good way to do that and also get a feel for which eSource solution will meet your organization or study’s needs. Lastly, when adopting eSource in your clinical study, ensure data management is included in study design discussions, by the protocol formation phase. Doing so will help enable time and cost efficiencies, and contribute greatly to optimizing study design quality.
Continuing the eSource Conversation
Acceleration of eSource adoption is a critical step in modernizing the conduct of clinical trials. Realizing this vision – one in which all source data, acquired through any context, whether via a healthcare professional, patient or caregiver, are completely electronic, high in quality, and meet the standards of regulators worldwide – is a significant effort. It will involve alignment and dedication from all industry stakeholders, including patients, clinical trial participants, sites, technology vendors, standards organizations, regulators, payers, and sponsors, whether from large multinationals or small companies. That’s why raising questions and creating a dialogue on the topic is so critical.
What else would you like to know about eSource? We’re eager to continue this discussion, incorporating as many perspectives as possible, so please feel free to send questions or thoughts to firstname.lastname@example.org.
About Tanya du Plessis
Tanya is Vice President of data strategies and solutions at Bioforum. She has vast experience across the industry through her current role at Bioforum, as well as the 14 years she spent with IQVIA (legacy Quintiles). Throughout her career, Tanya has worked with multinational pharmaceutical companies as well as small-to-mid size biotech and startups. She has led various data management operations and programs, heading numerous innovation teams and spearheading the development of strategies for customized data delivery solutions, focusing on timely, quality data.
A certified clinical data manager (CCDM, SCDM), Tanya holds a M.Med.Sc in Hematology and Cell Biology from University of the Free State in South Africa. She also has a project management professional certification (PMP, PMI).
About Bioforum the Data Masters
Bioforum the Data Masters is a data-focused Contract Research Organization (CRO), supporting clients in the utilization of their clinical data and guaranteeing its integrity and accuracy. Our goal is to consistently improve and innovate data processes to allow for the most efficient data submissions for our clients across the life sciences industry and the patients they serve.