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Blog: Best Practices in Safety Signal Analytics — Managing Today and Preparing for Tomorrow

With up to 30-50% annual growth in adverse event cases, how are pharmacovigilance teams managing with today’s constrained budgets, and what can Real-World Data (RWD) and Advanced Cognitive Computing do for tomorrow?

Safety experts from ArisGlobal and Blueprint Medicines discussed best practices in safety signal analytics during a recent webinar, with key takeaways noted below. Read on for a summary of the conversation.

Topics in this recorded webinar include:

  • Trends and Challenges with Safety Signal Teams Today
  • Near Term Improvements to Safety Signal Analytics
  • Setting Expectations with Real-World Data & Advanced Cognitive Computing
  • FDA’s Adoption of RWD and RWE, and the future of Life Sciences

Trends and Challenges with Safety Signal Teams Today

There are many macro pressures facing drug development and Pharmacovigilance Safety teams today, including:

  • Greater caseloads and volumes
  • Disparate data sources
  • Lack of budget and staff
  • Noisy data and safety signals environments
  • Slow and manual processes

For all these reasons and more, it is imperative for organizations to invest in new advancements in signal and risk management technology solutions so that their Safety teams can move with greater speed and efficiency when evaluating and processing signals.

“There are currently many labor-intensive human factors needed to assess before noise is considered a legitimate signal. Organizations must leverage technology in a more powerful, intuitive manner to be able to look at the data and weed out false positives. It’s just not possible to look at vast data sets and draw any meaningful conclusions in a timely manner without the technology to support it.”

– Anand Ananthakrishnan, Senior Director of Drug Safety and Pharmacovigilance, Blueprint Medicines

Near Term Improvements to Safety Signal Analytics

With 70% of biopharma seeing a maturity gap in safety signal analytics processing, what feasible steps will be taken toward improving safety signal analytics this year? Among the results of our audience polling, the group was split on what would be considered the greatest issue to solve for in signaling today citing equal parts:

  • High false-positive rates
  • Lagging signal detection time
  • Signal validation time
  • All the above combined/equal issues

“Organizations must utilize the assistance of advanced cognitive computing and predictive analytics to be able to adapt and process large volumes of data sets in the future or they will not be able to keep up with analyzation of signals,”

– Elizabeth Smalley, Director of Product Management, Data and Analytics, ArisGlobal

Setting Expectations with Real-World Data & Advanced Cognitive Computing

What can we really expect from Real-World Data (RWD), Real-World Evidence (RWE), and Advanced Cognitive Computing – and when?
According to the FDA’s definition, Real-World Data (RWD) is data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. Real-World Evidence (RWE) is the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD. Using real-world data processes in safety signal detection and analysis is still formalizing and evolving so it can be safely and widely used by all.

In an ArisGlobal webinar poll regarding the use of RWD in their current processes:

  • 20% of organizations said they currently use it in their processes
  • 7% said they plan to in the near-term
  • 40% said they plan to in the long-term
  • 33% said they were not sure

Of those currently using RWD in their processes, respondents cited the following sources for acquiring their data:

  • 44% are using registries
  • 33% are using EMR data
  • 11% both were using social resources and claims

“The value of data is game-changing, but many safety teams are not yet equipped to leverage it. Currently, almost 80% of healthcare data is created in unstructured formats, and contains multiple data sources.”

– Elizabeth Smalley, Director of Product Management, Data and Analytics, ArisGlobal

FDA Adoption of RWD and RWE, and the Future of Life Sciences

What does the FDA’s adoption of Real-World Data and Real-World Evidence mean for the life sciences industry? The FDA is committed to realizing the full potential of RWD and RWE in life sciences, with collaboration on many projects, such as Standardized Clinical Research Data (OneSource) and its mission related to automating the flow of structured EHR data into external systems.  Multiple FDA centers now incorporate RWD and RWE into daily activities based on the nature of their work and the scope of their regulations. Our Xtalks Webinar panel further explores the future impact of using RWD and RWE moving forward in life sciences …

“With the concept of detection, we are very focused on the process of adverse events – but what about the billions of research dollars spent each year trying to repurpose existing drugs? There’s also the potential with RWD/RWE to identify unexpected benefits of drugs, and if we can leverage this information to truly uncover the beneficial effects of products, RWD and RWE will go a long way in helping the validation.”

Emmanuel “Manny” Belabe, Vice President Solution Consulting, Global Commercial Organization, ArisGlobal

There are many things to consider when looking at how your organization manages safety signals. Download this Safety Signal Checklist and view our on-demand webinar hosted with Xtalks to learn more.

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