COVID-19 PROPELS A DIGITAL TRIAL REVOLUTION

COVID-19 impacts all of us significantly. Most notable are the lives lost, the struggling health care services, and the social distancing measures that affect our emotional wellbeing, along with the still unknown impact on the economy.

Clinical trials in trouble

In the area of clinical research, trial enrollment has dropped massively. A Medidata analysis showed an average reduction in trial enrollment of around 65%, comparing March 2019 and March 2020 (B. Adams, 2020).

The pandemic also poses obstacles to ongoing study conduct: lockdowns and social distancing impact compliance with visit schedules and assessments. In the worst case, trial facilities become inaccessible or unsafe, as hospitals are overloaded with COVID-19 patients. Efficacy and safety endpoints may be compromised, as COVID-19 results in excess deaths and complications throughout the study period. This can be especially detrimental to oncology studies, where survival is often a primary endpoint. Supply chain difficulties and availability and access to investigational products pose further challenges (F. Melhem, 2020; GlobalData Healthcare, 2020). Challenges drive opportunities Clinical trials are essential to developing new treatments. Remote patient monitoring, home care, and telehealth have been gaining momentum for some time, but COVID-19 is forcing through a (r)evolution in clinical trial execution, from the area of recruitment to that of data submission.

COVID-19 research is hungry for immediate access to real-world data in order to gain insights. Digital health technologies that enable continuous real-time data collection meet this need. Across COVID-19 clinical trials, social-distancing measures force the widespread use of virtual connectivity and remote monitoring and management, so we are likely to see a real acceleration in the uptake of new technologies and processes (D. Piekarz, 2020).

These technologies can significantly reduce the time, effort, and burden on investigators, clinical research centers, and participants. The industry has been discussing these benefits for years, but with the traditional ecosystem at a standstill, COVID-19 fuels the adoption of digital and virtual technology.

De EHR a EDC

One area in which to expect progress is the movement of clinical trial data points from electronic health records (EHRs) directly into electronic data capture (EDC), at scale.

Data entry and the verification of data entered in EDC is still mostly 100% manual. Transcription has long been the only method to get data into the study eCRF (electronic case record form) or EDC system. Transcription works across all data sources, but has significant limitations, especially human fallibility, which brings the need for validation and monitoring of the transcribed data. This monitoring is an additional resource and an extra effort. The resulting process can be one of the most problematic issues in clinical trials.

The reason we have transcription goes back to the beginning of the EDC industry. EDC was, and is, the method of digitizing subject data, so that this can become the clinical data reported to regulators, replacing paper. In the period of around 1998 to 2003, electronic hospital information systems were not yet generally available, but the ability to collect clinical data over the internet existed, and the industry needed a way to get valuable patient data into these new web-enabled EDC databases.

A new workstream developed around the manual transcription of source data into EDC, resulting in a “web-enabled paper process.” While EDC was successful at displacing paper, manual transcription created its own challenges, and still required source data validation (SDV).

Today, sophisticated EHR systems based on common data standards and interfaces have become available. In theory, therefore, we can make the EHR-to-EDC data transfer a reality. This would give us 100% accurate data, while eliminating the need for transcription and associated SDV and fulfilling the original promise of EDC: better data management that transcends data entry errors and focuses on clinical issues with the data. Bear in mind that we are talking about clinical trial data points and about transferring them from EHRs directly into EDCs.

In spite of the obvious benefits, remarkably little progress has been made in this area across the industry thus far (H. Levaux, 2018). But COVID-19 is propelling progress: I expect to see more studies where study data points are transferred from EHR straight into eCRF, and welcome an exciting new digitally-enabled future for clinical trials!

About the author Léon van Wouwe, MSc, is a versatile clinical research professional with over two decades of experience working in international drug development organizations, across a variety of therapeutic areas and development phases. Taking a holistic, ecosystem approach, Léon brings a broad cross-functional perspective and advocates for innovative approaches that address the challenges faced in drug development, facilitating more effective collaboration, in order to accelerate the development of new treatment options for patients.

Reference

1. Adams B, Global clinical trials take a major hit from pandemic, with endocrine targeted tests worst hit, FierceBiotech, April 8, 2020, disponible en: www.fiercebiotech.com/biotech/worldwideclinical-trials-take-a-major-hit-from-pandemic-endocrine-targeted-tests-worst-hit 2. Melhem F, The Global Impact of COVID-19 on Clinical Trials and the Way Forward, Technology Networks, April 20, 2020, disponible en: www.technologynetworks.com/drug-discovery/blog/theglobal-impact-of-covid-19-on-clinical-trials-and-the-way-forward-333652 3. GlobalData Healthcare, The impact of the Covid-19 pandemic on clinical trials, Clinical Trials Arena, March 20, 2020, disponible en: www.clinicaltrialsarena.com/comment/covid-19-pandemicclinical-trials 4. Piekarz D, Will the Impact of COVID-19 on Clinical Trials Fast-Track Digital Health Technology?, HCP Live, April 21, 2020, disponible en: www.mdmag.com/medical-news/impact-covid-19-trialsfast-track-digital-tech 5. Levaux H, Will the Impact of COVID-19 on Clinical Trials Fast-Track Digital Health Technology?, Clinical Pipe, June 19, 2018, disponible en: www.clinicalpipe.com/blog/why-pharma-needs-an-ehrto-edc-connection