Apr 6, 2018 03:59 AM
http://www.sciencemag.org/news/2018/04/c...nimal-data
EXCERPT: If you sign up to take part in a clinical trial, you can trust that scientists have solid evidence from animal studies that the test drug might work, right? After all, a study based on flimsy evidence would needlessly put your health at risk and potentially waste money.
But your trust might be misguided, according to a new study. So-called investigator brochures—the documents that researchers produce to convince regulatory agencies and ethical review boards that a proposed trial is worth the risk—are often lacking crucial information about the efficacy of the proposed therapy in animal models. As a result, it’s often impossible to tell how good the evidence is.
[...] Over the past few years, researchers have repeatedly shown that many animal studies lack scientific rigor [...] The team behind the new study looked specifically at the information researchers prepare to justify clinical trials in humans [...] The team found that 89% of the animal studies were not published at all, making it impossible for the IRBs to know whether the study had been reviewed by other experts. Additionally, fewer than 5% included important information on whether bias-reducing methods such as randomization of the experimental groups were used [...] Lastly, 82% of the brochures only reported studies that had positive effects. That suggests that trial sponsors leave out the less flattering studies...
MORE: http://www.sciencemag.org/news/2018/04/c...nimal-data
EXCERPT: If you sign up to take part in a clinical trial, you can trust that scientists have solid evidence from animal studies that the test drug might work, right? After all, a study based on flimsy evidence would needlessly put your health at risk and potentially waste money.
But your trust might be misguided, according to a new study. So-called investigator brochures—the documents that researchers produce to convince regulatory agencies and ethical review boards that a proposed trial is worth the risk—are often lacking crucial information about the efficacy of the proposed therapy in animal models. As a result, it’s often impossible to tell how good the evidence is.
[...] Over the past few years, researchers have repeatedly shown that many animal studies lack scientific rigor [...] The team behind the new study looked specifically at the information researchers prepare to justify clinical trials in humans [...] The team found that 89% of the animal studies were not published at all, making it impossible for the IRBs to know whether the study had been reviewed by other experts. Additionally, fewer than 5% included important information on whether bias-reducing methods such as randomization of the experimental groups were used [...] Lastly, 82% of the brochures only reported studies that had positive effects. That suggests that trial sponsors leave out the less flattering studies...
MORE: http://www.sciencemag.org/news/2018/04/c...nimal-data