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A study led by a professor at the federal technology institute ETH Zurich has found that many medicines are approved for use in groups of people who weren’t part of the clinical trials.
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People under 60, with no underlying health conditions or previous treatments – these are the kinds of patients typically included in clinical trials. Strict criteria mean only a narrow slice of the population is tested. That’s a problem, because the effectiveness and side effects of a drug are only measured in this limited group.
However, medicines are often approved by regulatory authorities for use in a broader population than the one tested. A new study highlights just how common this gap is between who gets tested and who ends up taking the drug.
An international team of researchers, led by Kerstin Vokinger, Professor of Law and Medicine at the University of Zurich and ETH Zurich, has taken a closer look at how medicines are approved. They wanted to find out how often the people tested in clinical trials differ from those who end up being prescribed the drugs.
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The team analysed all 278 medicines approved between 2012 and 2023 across Switzerland, the European Union (EU), and the United States (US). The findings are striking.
Medicines often approved for broader use than tested
In Switzerland, for example, 14.7% of medicines were approved for age groups that hadn’t been included in the clinical trials.
One case involved a melanoma drug trial that excluded people with heart conditions or organ damage. Despite that, the drug was later approved for patients with exactly those health issues.
In every category examined, and across all three regulatory authorities, medicines were consistently approved for broader use than they had been tested for. The most pronounced differences were seen in what researchers refer to as “patient fitness” – meaning patients’ overall health or general well-being. In nearly every case, there were mismatches.
People who received the approved drugs were often in significantly poorer health than those in the trial groups.
“These patient groups weren’t part of the trials. That makes it hard to predict how well the medicine will work or what side effects might appear,” says Vokinger.
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In other words, some patients may not benefit as much from the treatment or could experience side effects that weren’t picked up during testing.
Regulators acknowledge the gap but stress access matters
Swiss medicines regulator Swissmedic says it’s aware of the mismatch between trial groups and real-world patients. But it also stresses the importance of making treatments available to as many people as possible.
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Eveline Trachsel, who heads the agency’s authorisation division, says: “Even if we don’t limit the approval, this information is always included in the official documentation. That way, doctors can make informed decisions together with their patients.”
Swissmedic, along with other European regulators, has recently urged the pharmaceutical industry to design clinical trials that better reflect the diversity of patients who will actually use the medicines.
The research looked at every medicine approved between 2012 and 2023 in Switzerland, the EU and the US. It examined whether the people included in clinical trials matched those the medicines were later approved for, across five key areas: age, type of illness, severity of illness, general health and previous treatments.
The study was carried out by researchers from the University of Zurich, ETH Zurich, and the universities of Yale and Harvard.
You can read the full study hereExternal link.
Translated from German with DeepL/sp
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