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The good news is that such violations are rare, Seife told HealthDay. During the 2013 fiscal year, about 2 percent of the 644 inspections the FDA carried out at clinical trial sites were classified as OAI, according to background information in the study. But when these violations are uncovered, they can be serious enough to undermine the findings reported from the clinical trial. For example: The FDA deemed an entire trial devoted to the blood-thinning drug rivaroxaban unreliable, due to systematic and widespread scientific fraud. Despite this, the findings from the trial were published in a journal with no mention of the FDA's condemnation.
originally posted by: GetHyped
a reply to: machineintelligence
This is definitely an issue that needs to be clamped down on but let's keep a level head. This is far from normal practice:
The good news is that such violations are rare, Seife told HealthDay. During the 2013 fiscal year, about 2 percent of the 644 inspections the FDA carried out at clinical trial sites were classified as OAI, according to background information in the study. But when these violations are uncovered, they can be serious enough to undermine the findings reported from the clinical trial. For example: The FDA deemed an entire trial devoted to the blood-thinning drug rivaroxaban unreliable, due to systematic and widespread scientific fraud. Despite this, the findings from the trial were published in a journal with no mention of the FDA's condemnation.
Access to the information on the birth certificates allowed researchers to assess more complete information on race as well as other important characteristics, including possible risk factors for autism such as the child’s birth weight, mother’s age, and education. This information was not available for the children without birth certificates; hence CDC study did not present data by race on black, white, or other race children from the whole study sample. It presented the results on black and white/other race children from the group with birth certificates.
I regret that my coauthors and I omitted statistically significant information in our 2004 article published in the journal Pediatrics. The omitted data suggested that African American males who received the MMR vaccine before age 36 months were at increased risk for autism. Decisions were made regarding which findings to report after the data were collected, and I believe that the final study protocol was not followed.