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Blog

Challenging Randomized Clinical Trial Supremacy: Right to Try Legislation

marydrozario

A couple of weeks ago I spoke for the RTP SoCRA chapter on clinical research blinding history and current issues in clinical research blinding. You can find the slide deck here. The blinded, randomized, placebo-controlled trial, is relatively new, really only gelling into it's current form in the 1980s. It seems set in in stone, but it really recent. And the supremacy of the RTC was challenged almost from day one by the AIDS crisis. You can read more about that in And The Band Played On.

Today's challenges come from the Ebola crisis raising ethical issues about what real community consent means, an issue that has been simmering for all developing-world clinical trials, and from USA patients unsatisfied with the idea that a long testing process is necessary to protect public health, especially for terminally ill patients.

This has led to the development of Right to Try legislation at the state level. Currently 19 states have active Right to Try laws. These laws generally state that a terminally ill person can try a medication (or medical device) that has not been FDA approved if it has completed some level of testing, such as Phase I. They also generally state that the person or their insurance company can pay for the product, and that everyone involved is protected from liability. Some of them have additional restrictions such as that a clinical trial for their condition cannot be available within 100 miles of their address (Alabama).

As we have seen with other recent legislation on other issues, these laws challenge federal control. The challenge to the FDAs control of products they have not approved is obvious, but in the liability protections other challenges are necessary, including protecting treating physicians from sanction.

With Right to Try legislation, there are also questions about whether it is significantly different from the FDA's Compassionate Use program (supporters say Right to Try is more streamlined), and whether there are ethical issues with people who can pay for the product essentially "jumping the line" and possibly diverting resources from the product being developed through to FDA approval and widespread access. Again, this latter issue does not seem to be significantly different from concerns about Compassionate Use.

RAPS, the Regulatory Affairs Professionals Society, keeps a complete list of all active and draft laws. It's a fantastic resource, available here.