Accelerating Cures: Addressing Need While Avoiding Risk

The Annual International Meeting for ISPOR, the International Society for Pharmacoeconomics and Outcomes Research, presents much like a “buffet” of information. After feasting on what is sure to be a great variety of informational “snacks” from the short courses, symposiums, and poster sessions, be sure to leave room for the plenary sessions.  The first plenary session, “Accelerating Cures: Addressing Unmet Patient Need or Putting Patients at Risk,” is bound to kick-off an attractive discussion.

Many would agree that it takes too long to bring innovative drugs to market. According to the 21st Century Cures Discussion Document, there exist only 500 treatments for 10,000 known diseases, it takes approximately 14 years and $2 billion to develop a new drug, and nearly 95% fail during development.

Accelerating the delivery of a valuable innovation to the right patient at the right time is absolutely a key objective of the healthcare system as a whole. This particular discussion has prompted the introduction of many different pathways for speeding good products to market.

Whether it be the incorporation of patient perspectives into the regulatory process, public-private partnerships geared toward accelerating the discovery, development, and delivery of cures, or modernizing clinical trials – we must not lose sight of the importance of patient safety. In light of these pathways to acceleration, it will be increasingly important that we evolve efforts such as Sentinel to aid in picking up safety issues quickly.

Though the title of the session suggests a “this or that” mentality, as long as we keep patient safety in the forefront of our agendas, we may be able to address unmet patient need while avoiding putting patients at risk.

Though the emphasis is on accelerating cures, we must also remember the importance of quickening the generation of real-world evidence of the safety and effectiveness of new technologies.

The quality and availability of such evidence currently determines and will continue to determine the degree to which the information generated by patient surveys, collaborations, or clinical trials – is actionable.

We are pleased to see that regulatory pathways are being reconsidered, and look forward to seeing how this evolves further. In harmony with these efforts is our version of real-world evidence; trying to accelerate the generation of relevant evidence so that decisions can be made sooner.

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