Posts Tagged human trials


Posted by on Tuesday, 17 September, 2013

bad news




If you’re not one to take bad news lying down, you don’t have to.

Rheumatoid arthritis, cancer,diabetes, Alzheimers, or migraines. Whatever it is that can’t be fixed. You might be able to get into a clinical trial.

Here in the US, clinical trials  or (“human” trials) are conducted when a new drug or a new device or a new method has advanced to the point where it seems worth trying out on people. Usually, the whatever-it-is worked great on a bunch of animals and the investors are  congratulating themselves on their about-to-be-richness.

They should be so lucky.

Clinical trials are heart breakers.  The hopes and dreams of the developers are often dashed.

But you know what? It’s the subjects of these trials that MISTER ScienceAintSoBad feels for.  It’s their last shot. Nothing else worked. They knew it was just a chance. But still..


Would I succumb to my fate if there was a chance out there for me? No WAY!!!! I would figure out something! If it hurts, the heck with it. If I have to answer a thousand questions, fine by me. Just let’s get on with it.

If you’re willing to go another round, how do you proceed? Where are these trials? How do you get into them?

This should really be done with your doctor. I would like to think  your doctor would bring up appropriate trials at the right time.  (See below: Why Your Doc Isn’t Much Help With This Stuff).  In any case, a great resource for clinical trials is . It was started  by Kay Dickersin  and a group from The Center for Clinical Trials and Evidence-based Healthcare at Brown University.

A couple of things to remember.

First, be sure you get yourself a second opinion. Your doctor won’t be insulted and will  gladly make some recommendations. Doctors see this as a healthy double check on their work and gladly do it for others when they are called on. If you run out of options – if the second opinion is as pessimistic as the first one – ask your doctor about trials.

Seriously. You shouldn’t  feel you need to do this on your own.

Here’s the thing.

Clinical trials are labeled as phase I, phase II,  phase III or phase IV. Phase I’s where the big problems show up. They’re looking at side effects and what can be tolerated. Enroll in a Phase I test if you want to help the human race. Enroll in something else if you want to help yourself.

Phase II’s where thing’s get more interesting. This is where we’re starting to figure out “efficacy” and trying to figure out what’s the right dose.

Phase III trials are often the big expensive ones. This is where people are  recruited in various locations around the country. They’re the make/break tests for approval by the FDA.



If you’re looking for a “miracle” (the quotes aren’t there to make fun – just something you do when you’re Mister ScienceAintSoBad) you’re interested in Phase III trials. But. remember, even in a phase III trial there’s a good chance you may be placed in a control group, meaning that you don’t get the drug or its benefits. And trials are EXPERIMENTS. They’re risky. You might have a better (short) life if you just carry on.

Don’t  forget that you may be able to argue for “compassionate use” (single patient access) meaning, I’m not about proving anything just hand over the drug please.

Not EVERYONE wants to die for science. This might work best if the trial subjects are already enrolled.



Well most doctors  COULD get you hooked up with a clinical trial – one that offers some new hope. But they probably won’t. Denise Mann (Web MD) says most patients who could qualify for clinical trials, won’t even hear about them from their own doctors.

This doesn’t mean doctors don’t care. The ones I know and the one’s I’ve worked with are amazing. They work hard and they’re usually very smart. But they’re human, okay? Just so many hours in a day. Just so many dollars in a paycheck. They can’t be everywhere. Can’t do everything. Gotta go home sometime. And this has a lot to do with why they’re shy about introducing their patients to clinical trials. Keeping up with 8,000 trials is SLIGHTLY impossible. When would that “keeping up”  happen? Before 5 AM? Or after 2 PM? Medicine is intense. The hours are long and the stakes are high. And there’s a lot of required reading just to stay current in day-to-day practice.

Also, there’s the relationship with you.

Maybe a particular clinical study does offer  a shot (usually a long one).  It probably means the patient’s off to some distant place at a time that is emotional horrendous for him.her.  And the patient and the doctor have an established  relationship. Believe it or not, separating from the doctor  can be tough for both the patient and the physician.


People, naturally, do the regular stuff first. If things don’t work out, maybe they start looking around for something a little bit crazy. Most people see clinical trials as  extra innings  (a little baseball metaphor here).Well that could be too late. Some of these trials won’t let real sick patients into their programs. They need to get at them earlier.

Even though I don’t know you, I just want you to know that I sincerely hope you will get better and get your old and wonderful life back.


 MisterScienceAin’tSoBad would never, knowingly, give you any bad advice or misinformation but biomedical engineers don’t treat patients and shouldn’t give medical advice. This is the best information I have but but where your health’s at stake, please get a second opinion on my own words, okay?


The cartoon is mine