A year or two ago, the team at Clinical Ink noticed a lot of growth in CNS and pain trials. These trials are demanding from a data capture standpoint: complicated eligibility criteria, extensive monitoring requirements, comprehensive data collection, and substantial demands on patients all must be overcome.
Knowing this, we facilitated conversations with key opinion leaders from CROs and pharma in eCOA, ePRO, and direct data capture (DDC), or what might be thought of as an EDC model (learn the difference in this blog). We wanted to know their pain points and expectations for service and technology in this space.
We expected these thought leaders would outline useful bells and whistles — and they did cite a few. But even more importantly, they expressed a universal hunger for experience-based guidance. They understood that trial success depends on both teams and technology: It’s not enough to just be given ePRO/eCOA/DDC as a commodity. These customers wanted an experienced, consultative partner that could offer not only the most useful tools, but also the best practices for how to use those technologies in the client’s therapeutic area.
These conversations culminated in Clinical Ink’s specialized pain/CNS/neurology offering. As a bonus, they also gave birth to a whole constellation of other therapeutic area-specific offerings:
- Lupus – eLAS (electronic Lupus Assessment Suite)
- Question to question edit checks
- Autocompletion for duplicate data
- Respiratory (COPD/Asthma)
- Infectious Disease
The common denominator for all of these offerings is well-thought-out functionality specific to the therapeutic area coupled with highly consultative, experience-based guidance that ensures clients receive a complete data collection solution that fulfills their exact needs.
A Service-First, End-to-End Methodology
From initial meetings through data archiving, facilitating specialized therapeutic area solutions requires specialized services and specialized technologies. To ensure the proper functionality is implemented with exceptional quality and timelines, feedback, guidance, and support are needed for everything from translation services to IRB/EC submission to logistics management and help desk.
Specialized technologies encompass optionality for BYOD, indication specific questionnaires, eligibility requirements, edit checks, and remote monitoring. Further, patient engagement and patient centricity are extremely important and we design our solutions accordingly. Clinical Ink delivers an end-to-end methodology incorporating best-in-class services for full therapeutic area suite solutions built on experience with more than 435 unique scales/questionnaires in 250+ global studies.
Breakdown of Studies With Clinical Ink’s Support by Therapeutic Area
CNS: An Example of a Therapeutic-Area Strategy for ePRO/eCOA & Direct Data Capture
It’s easy to see why CNS is a therapeutic area that can really benefit from a unique data capture application.
First, CNS primary indications range from Alzheimer’s disease to ADHD to bipolar disorder, epilepsy, and PTSD. Individually, these indications and diseases are complex. As a group, the requirements for clinical trial applications encompass a broad range of challenges that include:
- Varying cognitive levels of participants
- Utilization of caregivers or proxies
- Specialized qualification algorithms
- Unique compliance requirements
- Eligibility criteria driven by scores of various assessments
- Combination of on-site and at-home data collection
- Criteria-dependent tasks (timed assessments)
Development and Implementation: A Working Model and Solutions
From initial protocol review through deployment, our team engages the sponsor in a step-by-step collaboration, providing guidance, recommendations, and support to arrive at the best solution for the protocol based on best practices gained through our extensive experience. Study builds are protocol-driven and study-specific. Prototyping begins early with input from our PM and SME in collaboration with the sponsor study team, and continues through user acceptance testing (UAT), driving better experiences for study teams, patients, and site users.
Our tools are set up with a number of functionalities that enable complex assessments and structured diagnostic interviews. Standard questionnaires may be included, along with capabilities for recording audio, video, and images, including drawing and handwriting directly on the tablet.
When home data collection is necessary, our fully integrated ePRO and patient engagement application includes capability that accommodates easy-to-use, standard scheduled and event diaries as well as dynamic timed response diaries that improve compliance via real-time adaptive reminder notifications. There's even a compliance meter to help subjects gauge their own performance and compliance. Further, once-daily conditional email alert summaries for sites and monitors ensure full range support for the best possible questionnaire compliance outcomes . All of this may be set up for provisioned (Clinical-Ink-provided patient smartphones), BYOD (patients’ own smartphones), or hybrid (a combination of both provisioned and BYOD devices) solutions.
Standard or custom reports display diary data, including compliance status, eligibility detail, and custom scoring. Qualifying algorithms can also be incorporated to sort out, for example, what qualifies as a migraine to be treated or measured or to support rescue medication workflows.
In parallel, data management, site, and study teams may have need for data surveillance dashboards supporting detailed and accessible status overviews for key monitoring criteria across the entire study. These might show how enrollment and screening are progressing or provide insight to date/time stamp anomalies, or other risk areas identified for a specific trial.
These functionalities and more are applied to build a robust solution for ePRO/eCOA and direct data capture that supports proper protocol execution and helps patients adhere to the sometimes confusing and burdensome demands of these complex protocols.
Success Depends on Both Technology and Consultative Guidance to Make Good Choices
To make data central to your CNS and pain trials, working with an experienced, consultative partner is the key to success. A company with a service-first methodology ensures that you have a partner throughout the process so you receive guidance, support, and recommendations based on decades of experience.
A complete review of your needs in combination with strategies developed specifically for your therapeutic area will help us arrive at the best solutions for your protocol. Being able to review prototypes and see the build in action very early on allows you to be certain that it's patient centric and you're not placing any unnecessary burden on the patient.
A provider offering a robust set of capabilities — such as video recording for central rater review — is more likely to be able to accommodate the needs of your trial, providing you with the necessary tools to simplify monitoring and oversight.