Contributed Commentary by Kyle Hogan

November 16, 2020 | In CNS studies, to overcome the pileup of complicated eligibility criteria, extensive data collection, relentless monitoring requirements, and hefty patient burden, sponsors, research sites, and patients need a first-rate technology solution. Standard electronic data capture (EDC) applications into which data, once collected, is transcribed for easy handling are inadequate; the transcription step risks error and necessitates time-consuming validation and edit checks.

Noting an uptick in CNS trials, our team set out to develop a focused technology solution to overcome these obstacles and make data collection for these trials manageable. Based on our learnings and expertise, here are considerations for choosing a CNS technology solution.

1. Direct Data Capture (DDC) vs. EDC: Why eSource Matters

Source documentation is what it sounds like: that initial entry in the EMR, paper form, or electronic patient-reported outcome (ePRO) tool. eSource is the direct digitization of source data with no intermediate steps. This form of data collection improves overall data quality and visibility: Compared with standard workflows, it’s faster, more accurate, more consistent, and simplifies audit tracking. Ideally, eSource integrates ePRO, eCOA, and eConsent, including DDC for miscellaneous trial data: ECGs, blood or urine screens, images, videos, etc.

DDC and EDC may sound the same, but fundamental distinctions influence clinical research workflows, data quality, and timelines profoundly. Crucially, in DDC, researchers enter data points into the DDC tool in real time, as they are collected. By contrast, in standard EDC workflows, data points collected during the patient visit are later transcribed into the EDC tool. DDC is direct data entry at the moment that matters, when the patient is still present (and errors can still be corrected easily). Resultant clean source data engenders far fewer queries and increases productivity for sites. Avoiding the transcription step saves time, reduces error, and eliminates the need for source data verification (SDV)—a major burden of study monitoring—while making data immediately available for study teams to review. 

2. eSource Alleviates Numerous Pain Points in CNS and Pain Trials—But Nothing’s That Simple

The efficiency and real-time data availability eSource data capture technologies enable go far to help streamline site requirements and shorten study timelines in demanding CNS and pain trials. But, even in the context of an effective application, is this enough?

When we surveyed key pharma and CRO opinion leaders in eCOA, ePRO, and DDC, the answer was, no. They value a service-first, end-to-end approach that includes highly consultative, experience-based guidance in how to best apply our technologies in their specialties.

3. A Broad Range of Challenges Demands a Comprehensive Approach

From Alzheimer’s disease to headaches to epilepsy and PTSD, CNS indications are multilayered:

• Cognitive levels of participants vary
• Qualification algorithms, eligibility criteria, and compliance requirements are complex
• Data is collected on-site and at-home, sometimes from caregivers
• Criteria-dependent tasks abound, such as timed assessments

  For success, patient/caregiver engagement is crucial. Specialized technologies encourage protocol adherence and ease processes with options such as edit checks, remote monitoring, BYOD, and indication-specific questionnaires. For timely, functional implementation, everything from translation services to IRB/EC submission to logistics management to help desk requires feedback and support.
  

4. A Unified Platform Enables Efficient, Multimodal Study Builds

From initial protocol review through deployment, step-by-step cooperation, recommendations, and support produce the most apt solutions. A single design, interchangeable across smartphones, PCs, and tablets, delivers the best study team, patient, and site user experiences. Collaborative prototyping should begin early and continue through user acceptance testing (UAT). Easily configured tools enable structured diagnostic interviews and complex assessments. Standard questionnaires and graphics capabilities should be included.

 A user-friendly ePRO and patient engagement application with dynamic timed-response diaries can improve compliance via real-time adaptive reminder notifications delivered on provisioned or patients’ smartphones.

For sponsors, surveillance dashboards facilitate monitoring of patient diaries, eligibility, and safety data as well as enrollment and screening stats or date/time stamp anomalies. Algorithms can be incorporated to determine, for example, what qualifies as a migraine and to support rescue medication workflows.

A compelling solution for ePRO/eCOA and DDC must include functionalities that promote correct study execution, afford study teams real-time data visibility, and help patients stay engaged and adhere to demanding CNS protocols.

Powerful, Adaptable Technology Must Be Backed By an Experienced Partner

Finding an experienced, consultative partner that offers highly adaptable eSource data capture and integration solutions (ePRO/eCOA and DDC) can streamline site requirements and shrink study timelines for CNS trials. A fast and successful study build configured to your needs requires therapeutic area-specific strategies and guidance from an attentive, knowledgeable team. Review prototypes and test out the build early to ensure the design is patient-centric. BYOD, real-time adaptive reminders, rescue medication capabilities, and video recording for central rater review may further facilitate your trial.

Kyle Hogan is responsible for the strategic alignment of Clinical Ink’s application for ePRO/eCOA and patient engagement. With 15 years of experience in clinical trials, Kyle has managed global ePRO trial deployments and has been instrumental in development of Clinical Ink’s mobile solutions for patient-centric ePRO/eCOA. He can be reached at kyle.hogan@clinicalink.com.