Tokyo- The scientist at the center of allegations of data manipulation in the study of a large Alzheimer strongly defended the data integrity, but acknowledges gaps in project management.
in its January 10 edition of the morning, Asahi Shimbun , one of the leading newspapers in Japan, said the researchers involved in the disease continues $ 31 million Japanese to Alzheimer neuroimaging Initiative (J-ADNI) changed some memory tests details long after the data has been collected and some participants were incorrectly included in the study.
"the Asahi story is completely false," said Takashi Asada, a neuropsychiatrist at the University of Tsukuba who is in charge of the clinical aspects of the study. In an interview with Science Insider, Asada said a check for prepublication data subject to standard project turned datacenter to enter suspected errors incidents reported by Asahi . We asked the researchers to first line to double check their records, and corrections were made, where appropriate. "This has not been falsified data but rather to correct data errors," said Asada.
A second problem that Asahi marked was the inclusion of patients who did not meet the study criteria. Asada said there are some cases that have resulted from human error. for example, he said, only patients up to 85 years were to be included, but some older patients were included in the test either because researchers have misunderstood or do not follow the study protocols. data from these patients will be omitted from the analysis and publications, said Asada. J-ADNI directors discussed how to deal with data processing problems when the story Asahi appeared, Asada said. the missteps of the study management, he said, stemmed in part a lack of experience in handling large clinical trials in Japan.
Asada claims he was misquoted by Asahi and said he and his university have demanded that the newspaper is running a correction. The Asahi stands by its report. "The article is based on reliable reports," wrote newspaper's public relations department said in a statement faxed to Science Insider. Despite his assertion that Asahi charges are based on misunderstandings, Asada recognizes that they should be put to rest. The University of Tokyo, where an ethics committee approved the draft protocol, accepted a request from the Ministry of Health to investigate, but how and when is still to be decided by a public relations officer in the university. "We are convinced that new surveys will find no deliberate falsification in the J-ADNI data," said Takeshi Iwatsubo, a neurologist at the University of Tokyo, who leads the J-ADNI effort. Researchers from several US d Alzheimer expressed support to their Japanese colleagues on Alzforum.
Funded by the Government and a consortium of pharmaceutical companies, J-ADNI involves 38 institutions across the country. It is modeled on neuroimaging Initiative Alzheimer funded by US National Institutes of Health and several pharmaceutical companies and foundations. Asada said Japan's efforts following the same protocols as the US study, so that the data can be merged. An objective says -it is to establish a basic progression of Alzheimer's disease to test drug efficacy.
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