Last OCTOBER, one of the largest pharmaceutical companies in the world, GSK, announced that it would make patient-level data available and publish the results of both clinical study reports (CSRs) and clinical trials.
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From January 2014 the European Medicines Agency will publish all clinical study reports - the data behind medical trials, which often run into hundreds of pages.
Dr Heneghan has also spent 'four to five months' negotiating access to data from GSK, makers of Relenza but has yet to receive the clinical study reports.
Dr Heneghan said that GSK had provided him with all 30 clinical study reports (CSR) - regarding its anti-viral flu drug Relenza whereas he had received just one regarding Roche's drug Tamiflu.
Roche says it has published 71 out of 74 Tamiflu trial results but these can be just short summaries and not the raw data of clinical study reports which can run into hundreds of pages.
They asked Roche for full clinical study reports, with study protocols, the reporting analysis plan, the statistical analysis plan and individual patient data so that all they could more fully determine what could be concluded from the studies.
Pushing a pill is not simply a matter of sending reports of clinical trials to doctors and hoping they will read them.
The study - which focused primarily on Seroxat - looked at clinical trial data and reports of adverse effects and found possible links between SSRI antidepressants and violent behaviour.
Third, Pfizer will disclose payments made to authors of Zyvox studies, reports, and clinical guidelines.
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Hopefully the reports of these clinical trials will convince the big pharmas to look for alternative strategies to combat dementia in AD.
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The class labeling is based on FDA evaluation of all statin labels, entry of new interacting drugs on the market, and a review of clinical data and post marketing reports.
Surely if DMAA was as dangerous as it has been made out to be in the media coverage, there would be a confluence of evidence from the risks identified in clinical studies and a substantial body of case reports tying those risks to adverse and fatal outcomes?
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Even after the long-awaited reports of two large long-term clinical trials designed to answer the question, we still have uncertainties.
The documents related to sponsors, clinical trials, overseas regulatory status, names of experts consulted and post-marketing safety reports.
The review team looked at several serious incident reports which revealed behavioural issues and dysfunction in relationships between the surgical unit and medical, clinical and managerial staff.
It added: "We do not believe there are any clinical concerns regarding the care of patients, but rather there are questions that need answering about how the trust reports information about their care for administrative and financial purposes".
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