"Clinical research is seen as more of a box-checking exercise, where we run fairly cut-and-dried randomized, placebo-controlled studies based on established protocols. "Many of us think of innovation as something that only happens in the laboratory," said Lenz. More recently, another promising strategy has emerged that could also boost success in the clinic by changing the way that clinical trials are designed. To tackle this challenge, Amgen has placed a large bet on human genetics, which can help to pinpoint drug targets that are more likely to lead to new medicines. "As an industry, we need to increase the amount we spend on drugs that reach the market and decrease the amount we spend on those that don't." "The single biggest category of spending in R&D is clinical development, and the overwhelming majority of money spent on clinical trials goes toward programs that fail," says Rob Lenz, senior vice president, Global Development. The cost of success is so enormous because of all the money invested in drugs that fail: 90 percent of test drugs that enter clinical trials never get approved. The price tag for new drug approvals has risen to roughly $2.6 billion, and $2.9 billion if you count the expense of required post-approval studies. The world's tallest structure, Dubai's Burj Khalifa, cost $1.5 billion to build, which is roughly half the average cost of delivering a new medicine to patients.
It's another example of how we're applying the power of innovation to meet the needs of patients who are facing serious illness. That's why Amgen is using the latest statistical models and real-world data to design studies that are more flexible and informative. They can help patients by stopping a study sooner if the test drug isn't working, and they also enable promising drugs to move ahead more rapidly. Learn which types of patients the drug really helps and bring in more of them.Ĭompared to conventional studies, these adaptive clinical trials have the potential to be faster, less costly, and better at showing a drug's true risks and benefits.Make the trial larger or longer to better show the drug's real impact.Eliminate doses that don't look safe or effective.Depending on the rules you set before the study begins, you can: Even then, you can't always know if a study failed because of the drug or the study design.įortunately, there are newer ways of designing clinical trials that let you change the design if the data you're collecting supports that change. You may be wrong in assuming which types of patients the drug will help.Since clinical trials are blinded to prevent bias, wrong assumptions may be hard to spot until the trial is finished.The doses you decide to test may be too low or too high.The study might be too small or too short to show the drug's real benefits.In fact, designing a trial often involves at least some educated guesswork, so there's always a risk of making a wrong assumption. In some cases, though, the drug itself might actually be pretty good, but the trial wasn't designed in a way that would show its true effectiveness and safety. Normally, when you hear that a clinical trial was unsuccessful, you assume the drug being tested wasn't very effective or safe. Clinical Trial Diversity and RepresentationĬlinical Trial Transparency, Data Sharing and Disclosure PracticesĪdverse Event and Product Complaint ReportingĮnvironmental, Social & Governance Report 2021Įnvironment, Social and Governance StrategyĬommunity Investment and Amgen Foundation
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