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This (almost) never happens


Nice to see ethics playing a role in drug development

About a month ago, I penned an article about Data Safety Monitoring Boards (DSMBs) and their role in the clinical trial process. This article was prompted by news that Titan Pharmaceuticals (TTP:AMEX) had a trial halted by a DSMB for safety concerns. I noted that DSMBs also have the power to halt trials for positive reasons, though this is very rare.

This week brings us an example. NitroMed (NTMD:NASD) announced their DSMB halted a trial early because it was no longer ethical to have patients in the control arm who could not receive the drug.

There are likely less than a half-dozen of these types of events in any single year. They are mostly confined to drugs targeted to small populations or a patient population who is on death's door from a disease with no good treatment. This makes NitroMed's announcement somewhat unusual since this is a heart medication. I suspect the fact that the target population was African-Americans had something to do with it since minority populations are horribly underserved by pharmaceutical companies. Unusual steps are often necessary to serve these important, but neglected, patient populations.

What happens in these situations is that all patients in the trial will now be eligible for the drug. The trial will continue as planned so the sponsor can collect important safety data. The action by the DSMB would have been triggered by the fact that even if all the remaining population on the trial drug were to not see a benefit, the trial would still clearly show an overall benefit.

And this is the key: The drug shows overwhelming efficacy with few clinically serious side effects. This is distressingly rare in drug development, hence the rarity of DSMBs stopping trials early on good news.

NitroMed's share price doubled on the news, which is certainly a good thing for its shareholders. Biotech investors must understand this is a present of the highest order, however, and never something smart biotech investors can count on.
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