Opening the digital front door to clinical trials means creating a great user experience for patients, clinicians and ultimately sites and sponsors. As anyone in healthcare knows all too well, it has historically been much easier said than done. However, the potential results are compelling: improved patient enrollment, patient consent, patient engagement and clinician satisfaction.
Why Implement a Digital Front Door: Clinical Trials Need Participants and Clinicians
Patient enrollment in clinical trials, as OpenClinica recently shared, is time-intensive, costly and challenging. Patient diversity and retention are too. Patient-related statistics for clinical trials are sobering:
- Patient Recruitment
- 67 percent of sites fail to meet patient enrollment.
- As many as 50 percent of sites enroll one or no patients in their studies.
- Patient Demographics
- The distribution of trial participants does not match the demographics of the population. For example, Hispanics are represented at a level that is only 53 percent of their overall U.S. demographic level. African American participation is even lower at only 43 percent1.
- Trial diversity is at the lowest rate in 10 years.
- Patient Retention
- 30 percent of enrolled patients drop out before studies are completed.
- 85 percent of trials fail to retain enough patients, increasing expense and time to market.
The statistics for clinical trial researchers are even more problematic:
- Clinician Participation
- 50 percent of sites say staffing is the top issue.
- Clinician Burnout and Burden
- Clinical research coordinators are stretched very thin.
- 60 percent of site staff spend 25+ percent of each day transcribing data.
- Retention
- Turnover rates for patient-facing staff range from 35 to 61 percent, approximately double the pre-COVID rate.
The digital front door addresses these challenges in a number of ways:
- It minimizes the need for patients to travel (e.g., remote screening, eConsent),
- Leverages pre-existing data sources and
- Reduces the burden of data cleaning and verification.
A good digital front door breaks down barriers between healthcare and clinical research.
For example, OpenClinica, in partnership with the Quantum Leap Healthcare Collaborative / University of California San Francisco and the U.S. Federal Drug Administration (FDA) as a part of Operation Warp Speed, built technology that auto-populates the EDC system through direct capture from EHR systems without need for manual abstraction.
This award-winning technology was deployed at eight clinical sites in the multicenter phase 2 I-SPY-COVID-19 platform trial (an adaptive platform trial of repurposed therapeutics for patients hospitalized with severe COVID-19), after the trial had been initiated with traditional transcription practices.
“The first four months of the trial were completely manual,” said Amy MK Rovitelli, Critical Care Research Coordinator at the University of Rochester. “My entire Monday morning and the better part of the afternoons – depending on the number of subjects I had on study that weekend – were dedicated to pulling data for the multiple subjects over multiple days.”
The introduction of automated source data capture through EHR-to-EDC integration led to an average time savings of 61 percent over sites using manual data abstraction, while eliminating most data errors and the downstream costs associated with cleaning and validation.
“The switch from manual data entry to digital data transfer enabled hours of data collection work on some of the most tedious and I would argue probably some of the most queried data to be completely accurate in just minutes,” emphasized Rovitelli. “The subsequent monitoring visits went so much quicker, and the number of queries dropped dramatically.”
Why Implement a Digital Front Door: Clinician, Patient and Sponsor Benefits
EHR-to-EDC integration enables digital clinical trials to auto-populate eCRFs on study day one, reducing manual data transcription from 25 percent of the day to mere minutes. This key component to a digital front door also means clinicians have more time for research, patient care and the application of scientific knowledge, and are able to work at the top of their license.
For patients, the digital front door in clinical trials delivers an easy, frictionless experience. It also satisfies patient preferences to use digital channels2 while improving communication and engagement opportunities. It means they’re not burdened with new technology and are able to use the devices and interfaces they already have and know. Smart digital tools help patients understand what they need to be doing and when. It means they only need to travel to sites when absolutely necessary.
For sponsors, the digital front door enables a more diverse trial population, a more predictable enrollment and improved patient and site retention.
To learn more about how to open the digital front door in digital clinical trials, read Opening the Digital Front Door to Clinical Trials.