How many people must participate in trials of new therapeutics before they are approved by the FDA? Elizabeth Tracey reports

July 20, 2021

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Bringing a new drug or biological agent to market is extremely expensive, a fact many manufacturer’s cite in pricing. Now a new study points to the fact that new agents are also very expensive in terms of human capital. William Nelson, director of the Kimmel Cancer Center at Johns Hopkins, explains.

Nelson: They ended up looking at 120 drugs and biologics. Thirteen of these secured FDA approval within this eight year span.  They found that almost 160,000 people had to be enrolled in more than 1300 clinical trials testing the agent, almost 48,000 in trials that led to approval, almost 111,000 in trials that didn’t lead to approval, and so they took a guess that there’s about 12, 217 participants in clinical trials per approved drug.  :30

Nelson says a single participant can cost between $10,000 to $100,000 to enroll and follow in a clinical trial. At Johns Hopkins, I’m Elizabeth Tracey.

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