{"id":68395,"date":"2016-10-06T12:33:06","date_gmt":"2016-10-06T16:33:06","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=68395"},"modified":"2016-10-06T12:33:06","modified_gmt":"2016-10-06T16:33:06","slug":"what-to-do-the-final-rule","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2016\/10\/06\/what-to-do-the-final-rule\/","title":{"rendered":"what to do? the final rule?…"},"content":{"rendered":"
Recently, FDA\/NIH\/clinicaltrials.gov<\/font><\/em> issued their long awaited reforms with something of a media blitz:<\/div>\n
    <\/p>\n
  1. Toward a New Era of Trust and Transparency in Clinical Trials<\/a><\/li>\n
  2. Trial Reporting in ClinicalTrials.gov — The Final Rule<\/a><\/li>\n
  3. New federal rules target woeful public reporting of clinical trial results<\/a><\/li>\n
  4. HHS Issues New Rules To Open Up Data From Clinical Trials<\/a><\/li>\n

    <\/sup><\/ol>\n

    I’m impressed that the N.I.H.<\/font> and its ClinicalTrials.gov<\/font> registry under the respective direction of Francis Collins <\/font>[NIH Director]<\/font> and Deborah Zarin <\/font>[ClinicalTrials.gov Director<\/font>] have done a good job of identifying the problems and clarifying loopholes. Dr. Collins focuses on the government funded studies and Zarin on ClinicalTrials.gov procedures. While I have something to say about their solutions [below], they’ve definitely taken a long look at the sins of the fathers and sent down some credible commandments. However, I can’t say that I was at all reassured by the FDA’s response. If they had a Press Release, I couldn’t find it. It wasn’t mentioned on their FDA blog. Here are the quotes from Robert Califf from the articles above:<\/div>\n
    \n
    From the STAT<\/font><\/strong> article [New federal rules target woeful public reporting of clinical trial results<\/a>]:<\/div>\n