Showing posts with label drug development. Show all posts
Showing posts with label drug development. Show all posts

Thursday, November 4, 2010

Cure for MS? Sure, if you get off your butt and enroll in a clinical trial!

So, here's the deal.  I realize I spend a fair amount of time ranting about stuff that I'd like to think I know something about but that you probably don't agree with.  I do it because I feel like being soft is not going to help anybody.  The stakes are higher for me and for you, so I'll do what I think works.  Don't read it if you don't want to hear it - but it may do you some good!

The real reason that I initially started this blog as you may recall, was to promote participation in clinical trials.  Clinical Trials: this I actually DO have some experience with, both as a participant and as a member/consultant on several IRBs (Institutional Review Board - the body charged with evaluating the research to ensure that it's scientifically sound, clinically relevant, and ethical - the IRB answers to the Feds).

I will post regularly on the different aspects of clinical trials and what they mean, how they're run, why they're important, and why they're pretty safe, but I'm going to start by making a general point (or two).  Clinical trials are the FDA's mechanism for testing, evaluating, and approving new drugs.  Guess what, folks - no clinical trials = no new treatments or cure.  This is the case with ANY DISEASE OR CONDITION.

Anybody know what the biggest bottleneck/source of delays in drug development is?  Anybody... anyone...  IT'S ENROLLMENT!  (the capital letters means I'm yelling it).  As I'll explain in a future post, it typically takes 10 years or more to take a drug from an idea to the pharmacy ("bench to bedside" in the pharma world).  we're all hoping for better drugs to make treatment easier, more effective, or even halt progression.  I've read that enrollment problems can lengthen the time-line by 30% or more.  The math isn't hard here - 10 years under ideal conditions is a long time to wait.  13 years is frustrating to say the least.  More than 13 years?  You can see why I feel so strongly about this.

Here's the other thing that I think most people don't consider, or understand, or... I don't know if they're even thinking "big picture" enough to care.  A failed drug trial (i.e. the drug trial that you're on that doesn't work and you think was a waste of time) is still a very big step for drug discovery and it brings us that much closer to something that works.  Here's why - What's the number one objective in a clinical trial?  To succeed, obviously.  As trial phases progress, you're talking more people and a lot more money.  The mantra of most companies performing clinical trials is "if you're gonna fail, fail early!"  This does a couple of things: 1) it saves money by not getting into the later stages of the trial, enrolling more volunteers and spending more money only to find out that it "almost worked."  2)  IT FREES UP A SPOT IN THE PIPELINE FOR A NEW INVESTIGATIONAL DRUG!

The objective here is to keep as many potential drugs in the pipeline as possible.  The more drugs tested - the more likely we are to find one that works... make sense?  DO NOT DRAG YOUR FEET!  Clinical trials are pretty darn safe and they are beneficial for a number of reasons besides the obvious - I'll get into that in future posts as well.  There are always risks, but there are risks associated with going outside, riding in a car, or taking a shower.  Don't be a baby about it - given your situation, don't you think that a little (perceived) risk might be invigorating?!  If it turns out to be a bad experience, you can always drop out.  They even draft that very language (i.e. "you may withdraw at any time") into ALL consent forms.  Give it a shot - PLEASE.  And do me a favor and let me know if you do.

*Remember, there are instructions for how to find a trial that's right for you on the right hand side of this page.