shutterstock_567828658.jpgAs the abundance of patient data continues to grow, the healthcare industry is continuing to find innovative ways to employ it. At the eighth-annual Summit for Clinical Operations Executives (SCOPE) held Jan. 24-26, attendees from across the life sciences space gathered in Miami to discuss how this abundance of data can be used specifically to improve clinical and observational research.

I was lucky enough to both attend and present at SCOPE, and I observed a few key themes throughout the presentations and discussions. Here are three:  

  1. The use of real-world data to inform clinical trial design: It’s no secret that clinical trials rarely go as planned. It’s well known that on average, 80% of clinical trials fail to meet milestones due to operational delays, such as limited patient enrollment. Insights culled from real-world data can help, but until recently, real-world data in clinical trial design has been used to determine trial feasibility at a high level. Now companies are going further and implementing a wider-reaching, systematic approach to real-world data, using it to enhance overall trial design and execution from the outset. Insights from real-world data sources—like patient journey data, competitor value propositions, electronic medical records, claims data and reimbursement information—can help companies identify the right patients for clinical trials, define the right drug attributes that will communicate value to stakeholders, and help position the product.
  2. The need for increased collaboration: In order to effectively employ real-world data—within clinical trial design and elsewhere within the drug development life cycle—collaboration is a necessity. Case in point: Some experts I spoke with in the clinical development field haven’t been exposed to real-world data at all. As a result, they have misconceptions of what’s possible. This misunderstanding—this lack of collaboration—could lead companies to either sit on the sideline or purchase large amounts of data without understanding what it can do. But by collaborating with stakeholders across your organization—and partnering with the right data and analytics vendors—companies can get the most out of their data-driven efforts.
  3. The promise—and challenges—of connected health: While the consumer market has seen tremendous growth in the connected health space, specifically with consumer devices like Fitbits, these devices aren’t medical device grade, so they don’t have the accuracy and reliability required to be effective within clinical trials. However, I participated in many roundtable discussions that revolved around cross-industry collaboration with a focus on applying and enhancing the technical innovations for the right use cases, and making digital health technology a more reliable element of clinical trials and research (such as patient engagement and novel end-point designs). This understanding, though, is just the tip of the iceberg. I’m hopeful for the advances to come.

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Topics: Qin Ye, SCOPE, clinical trial design, connected health, real-world data