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Compliance In Focus
Posted by Stephani Hulec on Mon, Apr 9, 2012

Outside U.S. Clinical Trial Data

Drug TrialsSeveral weeks ago, I came across a Dateline NBC episode, which was entitled The Hansen Files:  Drug Trials.  The episode focused on clinical drug trials, which were being conducted outside of the United States, particularly in India.  There is a growing trend for companies in the U.S. to outsource recruitment into their clinical trials.

Possible benefits to doing so, as outlined in this 2008 article, may include:

• Cost savings
• Avoiding strict regulatory laws imposed by U.S. agencies
• Larger pool of potential study participants 

The issue is that in countries like India, many of the potential study participants may have neither healthcare coverage nor wealth- therefore, being asked to participate in a clinical trial where the opportunity for regular health screenings and monetary compensation may be too good to pass up.  The Dateline investigative report shed light on the possibility that the CROs and recruiters in countries like India working for pharmaceutical companies may not be operating under the most ethical practices.

However, several other articles, such as seen here and here, explore the other side to this issue.  These articles discuss how the Drug Trials episode did not explore all aspects of the issue; for example, that recruitment does not occur in this manner into Phase III clinical drug trials.  It was also stressed that the vast majority of clinical trials run in places such as India are well-conducted, and with leading CRO companies, unlike the lesser-known CROs interviewed in the report.

Do you think that the recruitment process for U.S. pharmaceutical companies is ethical?  Should any changes or regulations be imposed on this practice?

Photo Credit: GenBug

Topics: Clinical Drug Data, Dateline

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