How New Drugs and Medical Products are Tested

May 1st, 2008

Whenever a new drug or medical device comes on the market, the process leading up to FDA approval has been costly and time-consuming. Biotech companies spend many years working in their laboratories to develop new drugs to ready them for testing. Companies that can’t afford their own study staffs are increasingly turning to contract research organizations (CROs) to do the testing. Launched by entrepreneurs, an army of CROs is taking on the daunting task of testing for pharmaceutical companies without the time and resources to perform their own.

 In a few cases, these contract firms which have emerged over the past twenty years have not been up to the rigorous task of controlled clinical trials. Mistakes can lead to a product’s delay in being approved, or test subjects may develop unanticipated side effects.  Some bioethicists are urging more regulatory attention for CROs.  The FDA is looking at more stringent regulations of firms conducting clinical trials with human subjects, to hold them fully accountable.

Stages in the Drug Approval Process:

Preclinical trials Testing of a new drug is usually tried first on animals.

Phase I studies If laboratory testing of animals shows no harm to them, federal regulators often allow tests on 20 to 80 people, primarily checking for any ill effects.

Phase II studies These studies usually involve groups of up to 300 people in order to provide an initial assessment of the drug’s effectiveness.

Phase III studies Hundreds to several thousand people are involved in an attempt to determine whether a drug is safe and effective. If it holds up well and shows no unacceptable side effects, the medication has a good chance of approval and subsequent sale.

Source:  Oakland Tribune; April 25, 2008; business section

Entry Filed under: PRESCRIPTION DRUGS,SENIORS HEALTH