A Patch? YES – A Fix? NO: This Emperor Has No Clothes

The NIH Department of HHS released its Final Rule on “Clinical Trials Registration and Results Information Submission” [1]. This Rule is meant to address frustrating maintenance and compliance issues in the ClinicalTrials.gov database, especially the results reporting section which has Continue reading A Patch? YES – A Fix? NO: This Emperor Has No Clothes

Moving Towards Greater Transparency – One Step At A Time, Inexorably

Sharing trial data has been a controversial topic for quite a while. Recently the editors of major medical journals decided to take a stand. They will make access to trial source data a requirement, as a condition of publication, arguing that Continue reading Moving Towards Greater Transparency – One Step At A Time, Inexorably

Does The Taxpayer Get Rewarded For Funding Such Studies?

Cabotegravir (S-1265744) is an integrase inhibitor similar to dolutegravir.  When formulated as a long-acting drug using crystalline nanoparticle technology it is called GSK’744 LAP.  When injected intramuscularly, ‘744 LAP it has a half-life of >1 month which makes it ideally Continue reading Does The Taxpayer Get Rewarded For Funding Such Studies?

Ebola and “Breach of Protocol”: Makes Me Bristle…

We are told by Tom Frieden / CDC that it was a “protocol breach” when a nurse in Texas taking care of US Ebola patient no. 1 got infected?  At the same news conference, he tells us he doesn’t know what Continue reading Ebola and “Breach of Protocol”: Makes Me Bristle…