Ignorance is No Excuse - Pharmaceutical Executive


Ignorance is No Excuse
Keep up with individual state clinical trials requirements or face liability exposure

Pharmaceutical Executive

What trends do you see in states' involvement in clinical research?

The trend is that these state laws are going to become more important. In some states, like Massachusetts, for instance, a protocol approved by an IRB is reviewed by the state Department of Health as a matter of procedure. And they do that in case, all of a sudden, they see an influx of clinical trials in an area that may generate some moral or legal concern.

California is a very interesting state—it has the most regulations regarding clinical trials. Some of those are to sponsors' advantage, in that cancer therapies are greatly favored. You can actually conduct early phases of clinical trials in California without going through the FDA. It has its own Cancer Act that encourages research in cancer therapeutics. So California is a very proactive state in that regard, as it is for AIDS treatments. But it's also very conservative, in that if you're going to conduct a trial on any controlled substance—any scheduled drug—you have to have that clinical study reviewed by a review board that is under the authority of the state's Attorney General office. So if you start a trial with a controlled substance without approval, you can find that trial shut down halfway through. In California, clinical trial subjects must be given a copy of the patient bill of rights that explains their rights and responsibilities.

Most companies understand these regulations because they use local practitioners who are sensitive to them. And so from a strategic perspective, it's advantageous to choose a state that offers incentives or rewards for companies conducting trials in your particular area of interest or research. In some states, the cost of conducting trials will be lower, because health insurers are mandated to reimburse for general and routine costs involved in trials for those select therapies.

From a liability perspective, as a sponsor of clinical trials, you want to make sure that you're not being overly exposed to liability because you have not necessarily secured proper consent. In some states, consent forms only have a life span of so many months. In Wisconsin, for example, a consent is only good for 18 months. So if you have a long-term study, you need to make sure that you're reconsenting people every year and a half.


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