Friday, June 7, 2013

Should the government-funded clinical trials system be reviewed?

Yesterday, I came across the article US clinical-research system in need of review written by Gretchen Miller which pointed out that the pace and speed of clinical trials has left many government run organizations with out the proper time, individuals and information to make the proper decisions on how the clinical trials are conducted.

With this in mind, Miller has defined these as the main problems facing government funded clinical trials.
  • - There is inadequate expertise
  • - There can be conflicts of interest
  • - Exclusivity issues
  • - Increased cost of clinical research and fewer treatment-naive individuals (those who have not been treated with any drugs of the class in question) in the United States
  • - A common defense is that breaches of ethical and scientific guidelines are rare
With these main problems in mind, Millers is calling for a reconsideration of the way that government funded clinical trials are funded and performed.  He points to the fact that Institutional Review Boards don't have the expertise to fully understand and pass judgement on clinical trials.

Do you think that that government run clinical trials need to have their processes re-written?  Why or why not?

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