Sunday, 11 September 2011

Education. Drug-The Game. Time lines

Remember we were examining the drug development process, using
Drug-The Game See Part I, Part II, Part III, Part IV, Back Again (read after part III)

You asked for Time Lines about how long for useful drugs.

It is not possible to predict, because each drug is different and the problems they encounter will be different. However "If I came up with the idea for the cure for MS tomorrow how long would it take?".

Well if you start with an Idea at 12, it'll be about 3 before you even start Drug-the Game. Even after you show that the drug is active in animal models of MS, it takes time to get your drug ready for testing in humans and about a year to do the early safety studies in humans. You are now at 6. The trials in MSers (Phase II) take 2-3 years for a drug that effects relapses so we are at 8. For symptom control drugs this will be shorter maybe about a year. For progressive MSers I am sorry to say that we are not yet totally sure (as we need to get an active drug) but hopefully should be no longer than for relapsing MS.
The trials in MSers to show the drug really works (phase III) will take a year or more longer than the earlier studies as it involves alot more MSers than the phase II studies. Therefore it takes more time to recruit enough people for the study So we are now at 11. It takes about another year sorting out the paper work and then getting the regulatory bodies to approve a drug (so we are a 12). Then maybe another year whilst NICE make up their mind about the value of the drug. So we are at 13 and this is "Year" watch. Tysbri took about 14 years to go round the board. I am sorry it is painfully slow..but this is the process that every drug no matter what disase is being examined, must take. The aim is to find drugs that work and are safe. This is set by the regulators. When some drugs were fast-tracked to save time, in some instances safety issues appeared suggesting that a more cautious approach was best. It's all about safety.

As mentioned in part VI, one may start with a drug known to be safe in humans and speed the process up.

In addition there are drugs at 11-12 and you'll hear about these from Prof G as they appear on the horizon. There are also drugs at every stage of the game as we speak, and yes there are drugs aimed for progressive MSers in development.

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