Re: Getting into New Trial

[Guest guest]

> A person on dialysis, would not be a good candidate and would probably be

rejected. Once my bun was high and other time my calcium was low. It's almost

like a tryout for a play. It is up to the drug companies who make that

decision, not to the doctors who are conducting the trial. In some cases, they

may intervene on your behalf, however. I felt like when I was accepted into a

trial, it was like a rite of passage.

___________________________

Hi Lottie,

I hope that you do get into the Ariad trial and that this drug is a winner for

you. This drug has lots of promise of being a front line drug at some time in

the future.

But to clarify something.....first all, the drug company has MDs and researchers

on their staff that design the trials. Also, the drug company does NOT do this

alone. They need the FDA approval for the design and criteria for participation

in the trial (this is not at just at the descretion of the drug company). The

trial needs to be scientifically designed to have any significance/relevance.

The reason that they would probably exclude someone on dialysis or another major

type of health issue, is how do you know if a problem arises whether the drug

and cml or the dialysis is causing the problem. You can not have that many

variables in a drug trial, but that is also why there is the option sometimes of

a patient in need getting a non-approved drug under compassionate use.

The phase 1 trial, that Bobby is in, is to determine that taking the drug is

actually safe and does not cause death or other significant medical issues.

Because with cml it is easier to determine the effectiveness of the drug (the

efficacy), we also see this in a phase 1 trial.

The phase 2 trial is to determine the appropriate dose of the drug for

effectiveness. What is the minimum effective dose and what is the maximum dose,

that is starting to cause toxicity problems.

Nothing about a drug trial is left to chance, it is designed by possibly the

researcher who developed the drug (Dr. Druker in the case of Gleevec, and Dr.

Talpaz in the case of Sprycel), the drug company and the FDA. Nothing goes to

human trials without the approval of the FDA. When you participate in a drug

trial, your doctor is just following a very specified protocol...which is the

way it should be. This is scientific research. Once a drug is approved, your

doctor has leeway to use it as he sees fit, and even prescribe it off-label.

So, whether you get into a trial or not is determined by whether you meet the

very specific criteria for participation set for the trial, and this is

identical at all trial centers.

I hope you drug trial audition goes well!

C.