A Q&A with Deepu Joseph on eSource
Medrio recently interviewed industry thought leader, Deepu Joseph, Vice President and Global Head of Clinical Data Management of Quanticate, about the trend toward increasing eSource technology adoption, and the resulting benefits in improved data quality and patient-centricity. Deepu has over fifteen years of experience in managing and driving clinical data management operations delivery across major CROs experience.
- Medrio: What do you define as “eSource technology”, and which technologies do you believe hold the most promise for clinical trials?
DJ: Technology that enables us to initially capture data electronically can all be called eSource. This could be EMR/EHRs, ePROs, eCOAs, mHealth tools, wearables etc. From a clinical trial point of view, eSource refers to the part of the protocol defined data which is captured by sites directly in electronic platforms (e.g. Medrio DDC). This eliminates the step of primary data collection with paper or other platforms, where data is transcribed to make it available along with eCRF data or other data streams. Direct Data Capture enhances data quality and process efficiency, and increases the chances of accessing and analyzing real time data during the clinical trial process. This is critical from a patient safety perspective – timely decisions can be made and measures can be taken to ensure participant safety.
After the advent of policies like the 21st Century Cures Act, collecting data closer to the patient could be seen as the best way to ensure patient centricity and engagement. Some of the most promising technology advancements for future research are considered to be:
– AI/ML based platforms that support enrollment of subjects in clinical trials
– AI based medication and protocol adherence support
– Innovation in eCOA technology to facilitate a more patient centered approach to trial design and administration
– Interoperability: Platforms that enhance interoperability between various electronic data capture systems like EDCs, EHRs, mHealth, RWD sources, etc.
– Centralized Data Platforms: Smart technologies that integrate data from various streams to expedite analysis and understanding of the data
- Medrio: Is eSource perceived differently around the world?
DJ: The arrival of eSource signals a great shift in the conventional methods of data collection in clinical trials. The idea of improved data quality and process efficiency at sites is at an “all hands up” level of acceptance across geographies and regulatory bodies. However, regulators are apprehensive about the integrity of the medical records, which is a concern that needs to be addressed. By visibly streamlining upstream and downstream workflows during eSource implementation, we can help create acceptance and transparency. Adoption will begin with assurance that eSource maintains specific boundaries for data to be collected and processed by sponsors, as per existing data protection policies, and ensures the appropriate data is added to medical records at the site level – both for local patient engagement and treatments.
- Medrio: How does the use of eSource technology impact clinical trial design?
DJ: We are in the age of a patient centered research environment. eSource technologies can help us collect data specific to the patient experience, not just from a safety or efficacy perspective, but from a comfort, convenience of treatment, and outcome preference standpoint. eSource presents enormous potential for the industry to further investigate rare diseases and treatment options, especially compared to traditional methods, where participants are faced with geographic and logistical barriers.
- Medrio: How does eSource technology impact patients?
DJ: eSource can help patients participate in clinical trials in more comfortable ways. It also enables them to access and understand information about the trial more easily. Newer technology, like apps and wearables, help patients proactively manage health risks along with providing data for research. Strengthening patient engagement in research can in turn improve data quality and compliance, which are key to informing decisions based on the data collected.
- Medrio: How does eSource technology impact sites, sponsors, and CROs?
DJ: Creation of study specific source documentation consumes a significant amount of site staff’s time and transcribing those details to EDC/eCRFs adds to it. eSource eliminates these steps and gives sites more time to focus on patients. eSource also enables sites to conduct research in remote areas or satellite study villages with tablets and offline access. To maximize the benefits, there should be a focus on implementing sufficient infrastructure, tech support, and appropriate workflows at sites, especially when eSource is first implemented. In addition to the efficiency gain in trial conduct, Sponsors and CROs can access more real-time data, which promotes real-time monitoring of safety and data trends. This level of transparency is particularly beneficial for data management in adaptive studies.
- Medrio: What does receiving data in (nearly) real-time imply for the future of clinical trials?
DJ: Live data results in improved data quality, real-time monitoring of data, patient and site engagement, and better compliance. The key here is patient engagement, which is leading the way for us to solve a magnitude of chronic, acute, and rare health issues. Our communities are looking to us, those who are making advancements in research technology, to improve the health of our generation and the next.
- Medrio: What are your recommendations for implementing eSource technology and strategy?
DJ: Sites and patients should be the focus when implementing an eSource strategy. Understanding site level processes, standardizing workflows, and complementing eSource data collection should be prioritized. Exceptional customer support, guidance, and internal training are also critical to success. Making technology easier for patients to use and enhancing data capture quality benefits all aspects of clinical trials.
- Medrio: Are there regulatory guidelines, or considerations, that those interested in implementing eSource technology should be familiar with?
DJ: A critical consideration should be compliance with ICH-GCP, GDPR, and other data protection policies. Below are recommended guidances for organizations providing/planning to use such technologies in future trials:
– Electronic Source Data in Clinical Investigations from FDA
– Qualification opinion on eSource Direct Data Capture (DDC) from EMA on the Qualification application from Novartis Europharm Limited
Medrio: Thank you for speaking with us today!
DJ: Of course – thanks for a good conversation.
Quanticate is a global data-focused CRO specialized on the management, analysis and reporting of data from clinical trials and post-marketing surveillance. We provide high-quality teams that offer efficient outsourcing solutions including functional service provision models for clinical data management, biostatistics, programming, medical writing, data quality oversight, pharmacovigilance and consultancy.
Medrio’s eSource Suite includes ePRO, eConsent, and Direct Data Capture (DDC). Medrio’s eSource suite is unified with Medrio EDC to offer superior flexibility, streamline build and data management efforts, and offer feature-rich insight into real-time data. Offering the only offline data entry capabilities, and a 98% customer satisfaction rating, Medrio’s eSource Suite is uniquely suited to meet the needs of modern clinical trials.