Regulatory Focus™ > News Articles > WSJ: Sponsors Find New Clinical Trials Difficult for Old Drugs

WSJ: Sponsors Find New Clinical Trials Difficult for Old Drugs

Posted 16 February 2012 | By Alexander Gaffney, RAC 

When pharmaceutical manufacturers take a second look at their drugs to look for additional therapeutic indications, it's often a win-win for manufacturers and patients alike. Manufacturers are given the opportunity to receive additional revenue and marketing exclusivity, while patients are given the chance to receive a drug with a well-established risk pedigree and efficacy for new-and possibly neglected-indications.

At least that's the theory.

Getting these products to market by demonstrating their safety and effectiveness is proving to be a great deal more difficult in practice, reports The Wall Street Journal.

The Wall Street Journal articles notes that pharmaceutical manufacturers are having a difficult time finding patients to enroll in clinical trials for the products, citing patients who would rather take the product off-label than risk not receiving the treatment until the trial is completed.

The problems associated with enrolling patients into clinical trials come after manufacturers, research institutions and government agencies take second looks at already-approved drugs in the hopes of finding additional therapeutic indications.

Manufacturer's troubles with clinical trials don't end at patient enrollment. Additional clinical trials can also raise new safety concerns for a drug that weren't known before, increasing legal liability and attracting regulatory scrutiny to manufacturers, notes The Wall Street Journal.

Added to the exorbitant costs of clinical trials, some manufacturers may balk at the prospect of seeking additional indications in the face of so many difficulties.


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