A Leading Global Japanese Drug Manufacturer, recognized for its leadership in the Central Nervous System (CNS) space, was embarking on an early-phase clinical trial for a new epilepsy drug. As part of their research strategy, they aimed to better understand the natural history of epilepsy and medication adherence patterns. They needed access to a robust, patient-level real-world data (RWD) set to inform their trial design and recruitment. Additionally, they wanted to engage with a live community of epilepsy patients to gather prospective data on medication adherence, including using connected devices to measure actual intake.

Despite their extensive experience in CNS research, the manufacturer faced a significant challenge: they lacked a combined retrospective database for natural history insights and a live patient community for real-time data collection. Traditional methods of acquiring disparate datasets from multiple vendors proved inefficient and costly, leading to challenges in integrating data and gaining timely insights.

The Challenge

The key challenges faced by the manufacturer revolved around the need for comprehensive, cohesive data and effective patient engagement. Existing approaches required gathering data from various sources, resulting in fragmented datasets that lacked the consistency necessary for reliable, patient-level analysis. Additionally, the manufacturer needed a platform capable of offering historical data while simultaneously fostering real-time community engagement to support prospective research. Data integration posed a significant hurdle, as stitching together disparate data sources was both time-consuming and error-prone, leading to delays and increased costs. Moreover, accurately tracking medication adherence using connected devices proved essential for evaluating the drug’s efficacy, yet existing solutions fell short of delivering precise, real-time intake data.

The Solution: The BET Platform

To overcome these challenges, they partnered with Embleema to leverage the Battling Epilepsy Together (BET) platform. BET provided a dual advantage:

1. Retrospective Data for Natural History Studies: Embleema’s database contained comprehensive, patient-level data on seizure history, medication usage, and clinical outcomes.

2. Live Patient Community for Prospective Research: Through BET, the manufacturer could directly engage with a community of epilepsy patients, facilitating real-time data collection on medication adherence using connected pills.

Embleema’s HIVE platform played a central role by integrating patient-reported outcomes (PROs), electronic medical records (EMRs), and device data into a unified, high-quality dataset. This integration not only streamlined the data collection process but also ensured that all collected data met stringent regulatory standards, enabling the manufacturer to confidently use the data in their clinical trial submissions.

The Impact

By adopting the BET platform, they achieved the following:

• Enhanced Data Quality and Completeness: More than 95% of BET participants actively responded to surveys and reported seizure data, while over 70% shared their medical records, creating a comprehensive and robust dataset.

  
  

• Faster Recruitment and Data Collection: The manufacturer gained access to an actively engaged patient community, which accelerated the data collection process and reduced recruitment delays.

  
  

• Reliable Real-Time Medication Data: The use of connected pill devices through BET allowed them to accurately track patient adherence, providing essential insights into real-world medication use.

  
  

• Improved Data Integration: HIVE’s architecture enabled seamless merging of clinical, device, and patient-reported data, significantly reducing the manual effort previously required.

Curious how integrating patient communities with robust data solutions can improve your trial outcomes?