Examination of Clinical Trial Costs and Barriers for Drug Development. E.3.8 Barriers at Academic Institutions

07/25/2014

  • Sponsors might be compelled to select academic centers as sites due to the presence of key opinion leaders or specific patient populations.
  • Ethical and Regulatory Requirements
    • Academic institutions can take their responsibility to provide ethical and regulatory oversight to extremes and create excessive barriers to conducting clinical trials.
    • One study found that the average number of steps necessary to open a clinical trial at academic centers was over 110, in contrast to fewer than 60 steps at non-academic centers.
  • Low Priority of Clinical Research in Academic Institutions
    • Many academic medical centers undervalue or fail to incentivize clinical research.
    • Fundamental principles of clinical research are not included in academic medical curricula at the graduate or undergraduate level.
    • Those studying to be physicians are not adequately trained to interpret clinical trial results, impairing their ability to use such results to inform their clinical care and practice evidence-based medicine. For example, in a survey of 367 residents only 37.4 percent knew how to interpret an adjusted odds ratio from a multivariate regression analysis.

 

View full report

Preview
Download

"rpt_erg.pdf" (pdf, 1.89Mb)

Note: Documents in PDF format require the Adobe Acrobat Reader®. If you experience problems with PDF documents, please download the latest version of the Reader®