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Phase I Trials


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What is your opinion of phase I clinical trials? I know they are setup to determine dosage and may not really be of benefit. However, is there a chance for a really good outcome that makes it worth a try? Your thoughts would be greatly appreciated. We are going to have to decide between a phase I trial or Alimta unless we go elsewhere. Thanks for your help and take care.

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I'm always a fan of clinical trials but you have to understand what you are getting into with a phase I trial. While there is certainly always hope that the treatment will be effective, the trial is designed not to see if it helps the patient but to figure out what the side effects of the drug are and what the "maximum tolerable dose" (MTD) is.

Most phase I trials are looking at drugs that have only been used in animals and so they need to find out what they do in humans. Generally, they extrapolate from animal studies what a safe human dose will be. They then treat 3 people and see what kinds of side effects they experience. If no major (i.e. life threatening or seriously morbid) side effects occur, they will increase the dose for the next 3. They then continue to increase the dose until they run into major problems and the dose below that is the MTD.

Only after this do they go back and see if there was any benefit to the treatment. If it appears to have benefited some people, they proceed to a Phase 2 trial at that dose and then really try to figure out if it is likely to be a beneficial drug or not.

If you are looking at a Phase I trial, I generally would not want to be one of the first 3 or the last 3 on the trial!

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