Haven’t read yet.
ifp.org
“
In drug development, speed is critical. Each additional year a clinical trial takes can cost hundreds of millions of dollars, due both to ongoing trial expenses and the loss of valuable market exclusivity — the limited period during which a company has exclusive rights to sell a drug and can recoup its enormous R&D investments.
One way to shorten trials is through the use of surrogate endpoints. Traditionally, the Food and Drug Administration (FDA) approves drugs based on clinical endpoints: direct measures of patient benefit.1 These endpoints are definitive but often slow to observe, sometimes requiring years of follow-up. To accelerate development, regulators may rely on surrogate endpoints: measurable intermediate biological signals that reliably predict clinical benefit, such as biomarkers or imaging readouts. Rather than waiting years, surrogate endpoints predict clinical outcomes earlier, dramatically reducing the time and cost required to generate meaningful evidence in humans.
By lowering the cost and duration of clinical studies, surrogate endpoints make it possible to run more trials, test more hypotheses, and learn more quickly from failure — goals that sit at the core of Clinical Trial Abundance. A system with abundant, efficient trials is more likely to identify which treatments truly work, attract sustained private investment in medical innovation, and ultimately move us closer to what matters most: more effective therapies reaching more patients, sooner.
Yet behind this apparent simplicity lies a more complicated story. Within the biomedical community, surrogate endpoints are either treated with suspicion or revered with great hope. For example, many longevity researchers hope to discover new surrogate endpoints that reliably capture the aging process and unlock a path to approval for longevity drugs. By contrast, important voices in oncology, where surrogate endpoints have largely formed the basis for approval in recent decades, worry about an overreliance on these metrics.”
Proxy Praxis: How Surrogate Endpoints Can Speed Drug Development | IFP
A new series from the Institute for Progress
ifp.org
“
In drug development, speed is critical. Each additional year a clinical trial takes can cost hundreds of millions of dollars, due both to ongoing trial expenses and the loss of valuable market exclusivity — the limited period during which a company has exclusive rights to sell a drug and can recoup its enormous R&D investments.
One way to shorten trials is through the use of surrogate endpoints. Traditionally, the Food and Drug Administration (FDA) approves drugs based on clinical endpoints: direct measures of patient benefit.1 These endpoints are definitive but often slow to observe, sometimes requiring years of follow-up. To accelerate development, regulators may rely on surrogate endpoints: measurable intermediate biological signals that reliably predict clinical benefit, such as biomarkers or imaging readouts. Rather than waiting years, surrogate endpoints predict clinical outcomes earlier, dramatically reducing the time and cost required to generate meaningful evidence in humans.
By lowering the cost and duration of clinical studies, surrogate endpoints make it possible to run more trials, test more hypotheses, and learn more quickly from failure — goals that sit at the core of Clinical Trial Abundance. A system with abundant, efficient trials is more likely to identify which treatments truly work, attract sustained private investment in medical innovation, and ultimately move us closer to what matters most: more effective therapies reaching more patients, sooner.
Yet behind this apparent simplicity lies a more complicated story. Within the biomedical community, surrogate endpoints are either treated with suspicion or revered with great hope. For example, many longevity researchers hope to discover new surrogate endpoints that reliably capture the aging process and unlock a path to approval for longevity drugs. By contrast, important voices in oncology, where surrogate endpoints have largely formed the basis for approval in recent decades, worry about an overreliance on these metrics.”
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