When a group of researchers from McGill University in Montreal led by Dr. Jonathan Kimmelman conducted a study evaluating the relationship between preclinical studies and the efficacy of anticancer drugs, they found these studies overestimated anticancer effects by 45 percent.
Specifically, they analyzed the cancer drug sunitinib in all available animal studies.
This drug is an oral capsule taken to treat advanced renal cell cancer, gastrointestinal stromal tumors, and advanced pancreatic neuroendocrine tumors.
Kimmelman’s team discovered a number of issues throughout their investigation.
First, they noted standard practices like blinding or randomization were used in few of these studies, which are typically implemented as safeguards to ensure “personal expectations do not bias results,” according to the study.
Next, the authors found it was often unclear how many animals were tested because sample sizes were not reported. Test subjects tended to focus on juvenile female mice with compromised immune systems rather than be administered to a wider range of animal models.
These studies claimed the drug, sunitinib, was tested against multiple types of cancer and all showed statistically significant anti-cancer activity.
Kimmelman, though, found that result “strains credibility.”
“Preclinical research is plagued by poor design and reporting practices, exposing patients to harmful and inactive agents, wasting time in the lab and driving up the price of drugs,” said Kimmelman in a statement.
Some recommendations the authors have for avoiding these problems include constructing a method for easy replication of study results or implementingin vitro tests with drug levels that couldn’t be achievable for human use.
No concerns were raised, however, about the clinical use of sunitinib. - biosciencetechnology
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