Why do medical researchers take too long to start clinical trials?

Almost everyday there is a report of a cancer breakthrough preclinical trial, then it takes years for human trials to begin, if they begin at all. It's as if the researchers just want their egos stroked by their preclinical research, and are afraid of testing their research on humans for fear of failure. Take parthenolide...this kills leukemia stem cells, yet no clinical trial yet for about 3 years. nonsense. Then there is cyclopamine...may be great in myeloma, yet no clinical trial. More nonsense

Why do medical researchers take too long to start clinical trials?
Because the government tries to avoid having another Thalidomide problem...by making sure drugs are SAFE before they go to clinical trials.
Reply:As a cancer patient, I do understand your frustration with the process.





Funding is a major issue. Right now we as Americans are spending about 35 times or more in Iraq every year than we do for the budget of the NCI (National Cancer Institute).





The FDA also has very strict requirements on how drugs must be researched and what stages of research they must go through from the lab to human trials. Researchers cannot skip these stages or the FDA will not allow the drug to be approved.





I don't think the researchers are afraid for fear of failure. You don't know what they might find in between the preclinical trial and the clinical trial that would prevent it from happening. They might find out the compound has some very severe side effect on the liver in animals or kills too many animals when given. Or in some cases they do lose their funding, and then the compound gets shelved for a long time or forever, unfortunately.
Reply:You must keep in mind the important phases of a clinical trial. They have to start with dosing and then effectiveness. Once you reach phase 4 it might be yrs. Funding is also an issue. Remember the FDA? They are tough nuts to crack with the approval process. And again, it's a trial not a cure. And it is told to pts with the hope that testing a drug on them can help someone else.
Reply:the trial process is to insure the drug is reall efective for what they are looking for.





the human body is very complicated and they want to make 1000% sure it doesn't do more damage and that they got it righ for what they are treating.





as an aside - thalidomide; the poster child for bad drug interaction is a GREAT drug for treating Myeloma; discover over 30 years after the first botched release (that caused 1000's of birth defects).





doesn't have to do with egos's - i know some researchers that have discovered cancer drugs and they are usually the most down to earth people you ever met (like Julian A at Millenium - he invented Vlecade; one of the best Myeloma drugs in the market and he talks like he was barley involved)





I know it is hard - that is why they have fast track at FDA, more funding would HELP.





but bettert to wait and not put a bad drug in the market that does more harm





good luck,





jewells