Jonathan Andrus (JA), chief business officer with Clinical Ink, will be presenting eSource Direct Data Capture: Making Virtual Your Reality on Thursday, March 4 at 10:30 am EST. He shared a preview of the session, his perspectives after a quarter century in the industry, and what the future might bring for trial data management.
OSP: Could you please share an overview of how the process of collecting patient data has evolved in recent years?
JA: It is hard to believe, but this is my 25th year in the industry. When I first started out as a clinical data coordinator in 1996, I was fortunate to work on “cutting edge” technology, DataFax.
DataFax, at the time, was a fax-based clinical data management system that allowed sites to fax their barcoded case report forms (CRFs) to our servers, which then converted them to TIFF G4 images, optically character recognized (OCR) them, and took a first crack at reading what was written on the forms (early days of natural language processing (NLP). Compared to three-part NCR CRFs, which were the typical approach, this was huge.
Many years went by and the approach taken by companies did not change much. Early remote data capture (RDC) companies came on the scene; these RDC companies were the trailblazers to what would later be known as electronic data capture (EDC).
I was fortunate enough to later work for one of the earliest pioneers in RDC/EDC and see, firsthand, how some companies were willing to try new and innovative techniques to clinical trial data collection. Unfortunately, to this day, most companies have fully entrenched themselves with EDC and continue to require sites to transcribe data and, as a result, require the laborious process of source document verification (SDV).
There have been, however, more progressive organizations that, early on, knew that there had to be a better way. A better way of collecting data directly from the patient at the time of the site visit. A better way to use modern technology to enable unique approaches to study design and collect data from where the patient was – home, work, and other remote locations.
Over this past year, early 2020 until now, more and more companies have realized that they must fundamentally change the way that they are collecting data if they want to keep their pipelines going.
Decentralized clinical trials (DCTs) have now emerged as the go-to buzzword. DCT is a blanket term that can also cover hybrid and virtual clinical trials too. Regardless of the term or acronym that you apply to it, companies are now embracing new approaches for survival.
Patients do not want to come in for site visits, are apprehensive in participating in elective procedures and assessments, and do not want to be unnecessarily exposed to environments that cause anxiety around unnecessary exposure to COVID. The evolution to direct-from-patient data collection, use of at-home data collection tools and devices, and remote site visits are among the aspects that are being dramatically embraced across industry in a manner that is unlike anything I have seen in the past 25 years.
Further, regulatory agencies from around the world are producing and publishing guidance and information for industry in a manner that I have never seen before. Industry groups are forming and working toward solidly defining and describing terms and best practices that should be embraced to enable success.
OSP: What are the dangers and disadvantages of staying in the ‘stone age’ and continuing to operate with something less than fully advanced, like a paper/EDC-centric system?
JA: As indicated in the question above, this past year has required that companies do something outside of the humdrum EDC approach for the sake of their pipelines. The danger and disadvantage of staying “status quo” is that organizations will NOT be able to recruit and retain patients in their studies.
Patients have come to expect the ability to interact with healthcare professionals from the comfort and safety of their home. Solutions must be embraced by industry that enable a patient-first approach.
At the end of the day, solutions must work and enable patients to be able to be involved in critical research but in a way that works in the current pandemic setting. Regardless of what the future holds with regard to COVID, the industry saying of “no going back” must be embraced!
OSP: Could you please share an overview of how DDC works, and how it benefits sites, patients and other stakeholders?
JA: Direct data capture, or DDC for short, is the method by which data are captured directly from the patient at the time of the visit (at the clinic, at home, or virtually). As the data are being entered directly into the DDC tool, the system is providing real-time feedback on incongruent, illogical, or inconsistent data.
Information, taken directly out of the clinical trial protocol, can be surfaced in the DDC tool and provided as a “guide” for the site to carry out the respective visit. This can include both written guidance as well as interactive guidance (e.g., videos) to provide instruction on how to perform a particular assessment or a tricky study procedure.
So, from a site perspective, the benefits become quite clear – little to no transcription, real-time guidance/instruction provided within the DDC solution (busy sites working on lots of studies – having this, right in front of them, makes study execution so much better), and instant feedback on the data that has been entered without having to wait weeks for a monitor to source document verify (SDV) and issue queries on old data – is game-changing for sites.
DDC, from a patient perspective, allows the site personnel to allow patients to be able to capture patient answered data directly into an electronic tool too. Further, extending the direct capture of data to patients in their homes allows patients to be able to provide input on their quality of life and other important aspects of the clinical trial.
From a monitor’s perspective, when tools like DDC are deployed, it allows them to be able to review data and carry out source data review (SDR) as opposed to SDV. Monitors can review and monitor data remotely and then, when required, focus on the important aspects of clinical trial execution when they are on-site with the coordinator.
Other stakeholders that benefit from a DDC approach include data managers, raters (as it relates to the execution of subjective assessments of patients), and statisticians, to name a few. At the end of the day, collecting data directly from patients with real-time feedback and guidance improves everyone’s interaction with the clinical trial process.
OSP: Why is DDC especially beneficial with remote monitoring operations?
JA: DDC has been around for over a decade. For those organizations that embraced this approach, they were able to blaze the trail with allowing their monitoring teams to carry out remote review before they arrived on site for site monitoring visits. This, even before COVID, allowed these organizations to reduce the number of times monitors had to go on site and allow the monitors, when on site, to focus on the extremely important reasons for a site visit – drug accountability, investigational product (IP) storage, patient progress, training and refresher training, and being available to answer any and all questions around the conduct of the trial.
OSP: Please walk us through your SCOPE presentation, eSource Direct Data Capture: Making Virtual Your Reality. Who is your ideal attendee?
JA: Anyone interested in knowing more about what eSource is and how it can help their clinical trial programs. This includes clinical project/program managers, data managers, and those involved in overseeing entire clinical programs within their organizations.
OSP: What information will you impart, and what will sitting in on the session empower attendees to do?
JA: The information imparted will be focused on real-life examples of how studies can be conducted in a DDC manner and what the benefits and considerations are with this approach. The intent of the session is to give the attendee information that they can use to consider implementation within their own organization.
eSource Direct Data Capture: Making Virtual Your Reality is scheduled Thursday, March 4 at 10:30 am EST. For more information about the presentation or other SCOPE Summit sessions, visit scopesummit.com.