Ethical Concerns Over Outsourced Clinical Trials In Pharma Industry

April 21, 2011

According to published reports, there are frequent concerns in the pharmaceutical industry regarding the dangers involved in outsourcing clinical trials to contact research organisations or CROs. The key concern is that while rapid production along with cost savings are emphasized, ethical concerns and protection might take a back seat.

Analysts say that outsourcing drug development to developing countries puts the safety of drugs at risk. This is particularly pertinent in a sector where quick turnaround and cost cutting is the norm. It is imperative, under these circumstances, that there is better monitoring standards and mandatory registration of products with corresponding CROs.

In a report by SOMO, Center for Research on Multinational Corporations, a Dutch non-profit organization, the aforementioned concerned was raised, but industry watchers dismissed the concerns as being overly critical. Some also criticized the report for lacking in evidence of any harm done via loosely regulated oversight or improper functioning of sponsors.

As a result, the authors of the report acknowledged that their findings were not based on facts and that readers should jump to conclusions because their paper had stated that ‘extreme’ discrepancies in transparencies across the board in the pharma industry and among CROs was prevalent. Nonetheless, the paper did suggest some relevant suggestions in terms of improvement on this front.

The first of these guidelines includes a registration of all parties involved in a clinical trial. This should be a worldwide process and needs to include any subcontractors and contractors involved in the study as well. Additionally, the number of regulatory tests or inspections done on non-traditional areas should be hiked. In order to obtain 100 percent transparent along these lines, all audit results should be made 100% public, PRLog reports.

The cost pressures along with challenges during recruiting for trials is pushing clinical trials to non-traditional countries like China, Latin America, Russia and Eastern Europe.


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  1. Tatum on May 4th, 2011 2:26 pm

    There have been reports that the ability for companies to outsource drug manufacturing are becoming tougher. It will be interesting to see what new developments will be done abroad.

  2. Tatum on May 4th, 2011 2:27 pm

    There have been reports that the ability for companies to outsource drug manufacturing are becoming tougher. It will be interesting to see what new developments will be done abroad.

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