PLOS Medicine: Open Clinical Trial Data for All? A View from Regulators
peter.suber's bookmarks 2014-06-02
"Moreover, we take it as self-evident that the same standard of openness should apply to all (drug) trial data, whether sponsored by industry, investigator-initiated, or sponsored by public grant-giving bodies. Likewise, the same standard of third party scrutiny should be applicable to all secondary data analyses. Regulatory inspections of data and analyses carried out by commercial sponsors are routine. Would all sponsor-independent researchers allow the same level of inspections applied to their analyses?"