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eClinical Viewpoint Blog

DIA: Where Innovation, Regulation, and Patient Priority Intersect

Last month, I had the opportunity to attend the annual DIA Conference in Chicago.  It was my first time attending the conference and WOW! DIA was a delightful juncture to meet new people and learn from an impressive group of speakers and presenters. This year’s theme was “Driving Insight to Action” and below are some of the key takeaways from this remarkable conference.

Patient Centricity, Patient Engagement, Patient Priority

The industry now seems completely on board with focusing on the patient first and foremost. Several speakers discussed the challenges and opportunities around applying advanced technology solutions and where data needs to connect in a meaningful way to better serve patients through clinical trials.

James Seaton, Executive Consultant of Seaton Associates, LLC., emphasized specific strategies during his discussion that can optimize and increase patient engagement, and how patient’s perceptions can be validated against lab test/examinations to evaluate the side effects or negative impacts during trial phases. Discussions, such as the one James Seaton presented, showcase how valuable a patient accessible ePRO system is within our industry.

Regulation and Patient Priority

James Valentine, Juan Garcia Burgos, and Paul G. Kluetz covered how patients can contribute to the understanding of their diseases, and the way medicines are regulated; how patient engagement can lead to added value, better outcomes, and transform the way medicines are regulated.

In line with this industry, a transformation is the FDA’s support of reliable, representative patient input data to advance patient focused drug development with updated PRO data and clinical guidance documentation.

Integration of the data: Wearables

Innovative technology is making its way into our industry at a higher speed than expected and has an impact on the way we manage and monitor our clinical trials. Rob DiCicco, PharmD, Vice President of Clinical Innovation & Digital Platforms at GlaxoSmithKline, described the driving forces in the modernization of clinical trials. He discussed the role of the patient in the evolving clinical trial model and how there are several strategic drivers for the integration of digital/mobile technologies.

As innovative technology adoption intensifies, there is an increasing desire to collect and gather greater, richer data at a higher frequency. Discussions were strongly focused on how eSource can provide tangible benefits to sites, patients, sponsors, regulators, and drug and device companies through wearable and smartphone apps like mPower by Apple.

Moving Toward Data Standardization

Vaishali Popet, MD MPH, Associate Director of Biomedical Informatics at FDA touched on the impact of the Binding Guidance for standardized study data.  She emphasized how more complex and specialized products have become and how the technical demands have increased.  Data standardization will streamline the flow of data collection through submission and allow reviewers the ability to work with the data more effectively with less preparation time. In her review of the Binding Guidance, Popet went into depth on FDA suggested Technical Guides, Business Rules, and the FDA Data Standards Catalog and how these standards will provide a consistent general framework for organizing study data.

Changes are coming and the changes that are a high priority for organizations are, patient centricity, industry regulations, and data integration and standardization in a digitally changing industry. As a Product Manager at MedNet Solutions, I am always researching and looking for ways to improve our products and services. As a company, we are always abreast of upcoming changes in our industry and make sure we are navigating our product in the right direction. After attending DIA, it is encouraging to see that MedNet Solutions is on a parallel path with the industry and can provide our partners with an agile, efficient and effective EDC and eClinical technology.

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