Traditionally, convenience of protocol execution for sites has not been a major factor in clinical trial design. But you have to wonder why, given that sponsors depend on sites to properly perform the exacting, daily work of patient management and data collection. Common sense dictates that considering site workflows and providing tools that support effective protocol execution would benefit all stakeholders by easing the burden on sites while reducing errors and producing higher quality data. One such consideration is systems that allow sites to capture data electronically, during the patient visit. According to a survey by the Society for Clinical Research Sites, 79% of sites found it helpful to record data in a direct data capture (DDC) solution. (2017, Why Is Clinical Source Data Still Collected on Paper?)
The SLE Example
While investing in the most efficient, productive approach to help sites capture data accurately and reduce their workloads is always a good idea, it’s crucial in complex therapeutic areas.
Take lupus, for instance.
Systemic lupus erythematosus (SLE) is a difficult disease to study. To begin with, it’s a diagnostic challenge. Recruiting the right patients and collecting quality data for lupus clinical trials is problematic — so much so that only one therapy has ever been approved for this disorder.
Fortunately, Clinical Ink is offering new tools that make implementing trials in therapeutic areas as complex as lupus much more practical. By applying our clear and connected Lumenis™ platform, we create integrated technology solutions designed with site, sponsor, and patient input. These fit-for-purpose modules address the fundamental obstacles that hinder the development of novel therapies in demanding therapeutic areas.
Comprehensive, Labor-Saving Solutions That Improve Quality and Safety
Our electronic lupus assessment suite (eLAS™) facilitates data collection and patient engagement through eCOA, ePRO, and electronic informed consent (eConsent), helping make SLE research straightforward, efficient, and reliable. One challenge specific to lupus research is the combined use of multiple questionnaires. Not only are these questionnaires duplicative, but the symptom scoring criteria are different. eLAS solves both of these problems by sharing information between forms and displaying prompts that clarify the proper evaluation methods for that particular questionnaire. This is an excellent example of how a therapeutic-area-specific DDC solution can help make investigators’ lives easier and ensure correct protocol execution.
Experienced Clinical Ink project support services coupled with specialized, integrative data capture suites like eLAS give sponsors a clearer view of more reliable data for well-informed, optimal decision making. Specifically, Lumenis supports investigators with:
- One-time-only data entry for reduced workload
- Data shared across protocol-required questionnaires and visit histories
- Data entry screens based on familiar documents
- Data validation at the time of capture
- Queries minimized through real-time edit checks with pop-up data entry reminders so corrections can be made while the patient is still present
- Single tool for capturing all clinical trial data, including eCOA
- Clinicians able to enter structured and non-structured supporting data: numeric, text, VAS, audio, video, and handwritten notes
- Web-based data reports immediately available to study team
- Easier patient communications
Clinical Ink tools are designed to work completely offline to directly capture data and documents. Not only are they purpose-built with the right functionality to enable data corrections to be made before patients leave the facility, but time-consuming manual activities and the errors associated with traditional paper methodologies are eliminated.
Overcoming conventional data capture challenges helps sites and sponsors
With Lumenis’ fit-for-purpose, configurable clinical applications encompassing DDC, ePRO, eCOA, and eConsent solutions, you and your sites can expect a better clinical trial experience. With the support of eLAS, Clinical Ink has helped 1,100 sites execute their lupus protocols. Clinical Ink platforms and associated support services vastly reduce site workload and improve performance, data quality, and overall prospects for successful study completion.