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What Should You Know Before Entering a Clinical Trial?

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There are some 2,000 federally funded experiments at Johns Hopkins affecting as many as 200,000 patients, says Stephenson.

It's not clear just how many Americans are involved in clinical trials, but the number could be one million or more. In the wake of the Hopkins tragedy, and the crackdown on other research institutions for safety violations in recent years, just what should a person ask before enrolling?

Charo, who's also a member of the National Bioethics Advisory Committee, has the following recommendations:

  • What exactly are you planning to do to me? Step by step, day by day?
  • How many people have you done this to before, and what happened to them?
  • What happened in animal studies researching this drug or technique?
  • What do you suspect might happen to me based on all the other research that's gone on before?
  • What sort of things might make this more dangerous than usual?
  • How hard will it be to discontinue the medication?
  • What are my alternatives in a nonresearch setting?

Charo says many of the answers may already exist somewhere in the consent form, but not in user-friendly language. That's where the layperson's representative on the institutional review board is supposed to help out.

"You cannot use the consent form as a substitute for the consent process. The consent form is simply a piece of documentary evidence that a certain minimum amount of information was made available," she says.

Consent really means ongoing discussions between the patient and the researcher. As mileposts come up along the journey, they need to be fully explained. Such efforts can't prevent every tragedy, but they can improve understanding, which is critical to the research effort, says Charo.

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