Improving Clinical Studies and Benefitting Patients

Improving Clinical Studies and Benefitting Patients

By Margaretta Nyilas, MD, SVP, Clinical Management & Business Operations, Otsuka Pharmaceutical Development & Commercialization

Margaretta Nyilas, MD, SVP, Clinical Management & Business Operations, Otsuka Pharmaceutical Development & Commercialization

Technology has become an indispensable part of our lives as the convergence of technology trends, from cloud computing and smart devices to 3D printing, machine learning and the Internet of Things, is leading to an ever expanding digital ecosystem, connecting people, devices, processes and data. The steady pace of new disruptive technologies continues to transform our personal lives, as businesses also continue to realize increasing efficiencies and cost reductions.

"Near real-time risk- and remote-based monitoring of clinical data enables opportunity for real-time action"

The biopharmaceutical industry has in some ways been slow to embrace this new technology wave. But it is clear that increasing efficiencies in the overall development of pharmaceuticals will help bring new and targeted therapies to patients much sooner than the traditional model allows. Technology can be the catalyst that drives these new efficiencies.

My colleagues and I recognized that implementing truly real-time data observation, processing and analysis could dramatically improve the quality and efficiency of our clinical studies.

The traditional clinical trial process is labor-intensiveand complex, and delayed access to analyzeany data emerging from the study is inevitable. Patient consent forms are particularly cumbersome and can lead to regulatory findings if there are errors in the consent process.

We wanted to increase the quality, efficiency and precision of data collected by implementing a single, integrated and secure automated platform utilizing a unified hub to manage the clinical trial process. This is our digital trial platform, comprised of several components covering the clinical trial approach, from sourcing, consent, scanning and surveillance. Every component of our platform has been fully tested and validated, is HIPAA compliant and follows FDA guidelines.

With our digital trial soultion, data flows in real- or near real-time and we can remotely conduct risk-based monitoring of all aspects of the study. The study team can immediately access information on a single digital platform to analyze study performance and collect data from hundreds of sites in multiple countries. Visualization of data is available in real- or near real-time to all study partners to ensure high quality and safety surveillance.

This real- or near real-time risk- and remote-based monitoring of clinical data enables opportunity for real-time action. Long transfer wait times are eliminated, data trends and inconsistencies are quickly identified, duplicate entries are eliminated, data anomalies are addressed instantaneously, trend review and decision-making are faster, and current and future errorsare minimized. A real-time data view also allows monitoring of site/country performance, helps address issues around screen failure rates, and decreases enrollment and randomization of poor-quality subjects.

With real-time data analytics available, site visits are more strategically focused on site needs and addressing identified risks and sites needing more support, while ensuring GCP compliance and proper protocol adherence. Data quality is enhanced for all subjects through ongoing review of safety and scale data, demand is reduced on both sites and patients, and compliance is increased on all levels.

The way our automated system allows us to so closely monitor the study performance was simply not possible before, and activities that once took 6-12 weeks are now being reduced to just a few days. The reduced timelines mean we can obtain regulatory approvals and provide new drugs to patients much sooner. For study participants, the platform provides a mechanism to enhance patient engagement through targeted patient-facing videos and content to ensure the patient understands the demands of the trial. The entire consent process is greatly simplified for the patient. Additionally, the use of digital sensors and electronic diaries reduces burdens on study volunteers by allowing them to provide real-time data electronically. Importantly, real-time patient data improves patient safety by allowing for faster and more precise data review and ensuring the right study compound is being administered to the right patient.

We began piloting two components of the digital trialsuite in 2012. Now, two trials utilizing the full platform have been completed.

The full digital platform will be the standard for all studies initiating in the third quarter of 2016 forward. Two Phase 3 trials are live, with two Global Phase 3s starting this summer. All additional studies planned over the next 18 months will be utilizing the full platform.

Implementation of the digital platform was enthusiastically embraced within our organization. With the many benefits that the digital platform offers, our study teams have become full and active participants in our innovation R&D culture. Software has become a new core competency within our organization. By re engineering our internal capabilities into one integrated system, the execution of true paperless trials and submissions is becoming a reality.

We are excited to be pioneers and leaders in the effort to bridge healthcare and the power of digital technologies. What keeps us continually motivated to further advance the frontiers of innovation is knowing that our efforts help serve patients by developing new treatments for their needs faster and more efficiently.

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