CSTE logo
Clinical Trial Participants
Page 1 of 1
Thread Actions

12/31/2013 at 4:43:19 PM GMT
Posts: 1
Clinical Trial Participants

Recently, we discovered that some national clinical trials were not reporting lab results for participants living in Texas.  This was specifically an issue with clinical trials that process lab results (CD4's and VL) in house rather than sending the labs to a reference laboratory.  We contacted the clinical trial companies but did not successfully convince them that they needed to report lab results.  Have other states found this to be an issue?  Have other states had success in getting lab reports?

3/3/2014 at 4:14:43 PM GMT
Posts: 2
In NYS IRB approved clinical trials are exempted from public health reporting -- inclusive of lab reporting. This is a know, but not well quantified, gap in our laboratory reporting. Even if you are able to convince labs to report, they may not be able to report patient identifying information as many research protocols involve providing to the testing lab only coded names (i.e., the study ID).

This website uses cookies to store information on your computer. Some of these cookies are used for visitor analysis, others are essential to making our site function properly and improve the user experience. By using this site, you consent to the placement of these cookies. Click Accept to consent and dismiss this message or Deny to leave this website. Read our Privacy Statement for more.