anyone been involved in a medical clinical trial?

[CaliforniaDreamin]

I just found a clinical trial that i am desperate to be a part of. I emailed the place and begged them to let me in. Yes, thats pathetic, but I need to get in. How does this work? Do they take everyone who qualifies or do people get turned away? I know I'm not being very specific, but I can't. I just need some info on this works. I know things vary from state to state for trials, but can anyone share anything with me? Please!

 

[chloelovesdisney]

I just found a clinical trial that i am desperate to be a part of. I emailed the place and begged them to let me in. Yes, thats pathetic, but I need to get in. How does this work? Do they take everyone who qualifies or do people get turned away? I know I'm not being very specific, but I can't. I just need some info on this works. I know things vary from state to state for trials, but can anyone share anything with me? Please!

You need to meet the inclusion/exclusion criteria, and they need to be recruiting for the study. How did you find out about the trial?

 

[NotUrsula]

I've done a couple.

They tend to be VERY selective. They normally only want people who are likely to have successful outcomes, so you'll need to exactly fit the criteria and also do well in the interview. (They tend to want to weed out anyone with hypochondria and also folks who are taking meds not related to the study.)

IME, the most common reason that people are not accepted (other than the above) is logistics. They tend to need to have you come in at regular intervals during business hours, and if there is any chance that you are going to have work or babysitting issues that make you miss appointments, then they are probably not going to want you.

 

[CaliforniaDreamin]

You need to meet the inclusion/exclusion criteria, and they need to be recruiting for the study. How did you find out about the trial?

I do meet the criteria listed on the website and they are currently recruiting. I found out about the trial by doing a google search.
I emailed them and they wrote me back asking for my phone number to do a phone interview.

 

[CaliforniaDreamin]

I've done a couple.

They tend to be VERY selective. They normally only want people who are likely to have successful outcomes, so you'll need to exactly fit the criteria and also do well in the interview. (They tend to want to weed out anyone with hypochondria and also folks who are taking meds not related to the study.)

IME, the most common reason that people are not accepted (other than the above) is logistics. They tend to need to have you come in at regular intervals during business hours, and if there is any chance that you are going to have work or babysitting issues that make you miss appointments, then they are probably not going to want you.

Well, the logistics probably will disqualify me. The trial is in Maryland, and I live in NC. It's a 4 week trial and we don't have the funds to get me to Md and pay a months worth of living expenses. So my hopes have been dashed. I have got to stop getting excited about these small glimmers of hope, I just get let down. But thank you both for the info. I would be perfect though, I think. I only take meds related to the medical issue and I have plenty of documentation that I'm not a hypochondriac. Maybe one day they will do a trial like this a little closer to home.

 

[dejr_8]

What Phase of Trial - II or III?

 

[quentina]

I just found a clinical trial that i am desperate to be a part of. I emailed the place and begged them to let me in. Yes, thats pathetic, but I need to get in. How does this work? Do they take everyone who qualifies or do people get turned away? I know I'm not being very specific, but I can't. I just need some info on this works. I know things vary from state to state for trials, but can anyone share anything with me? Please!

My husband is starting one on 7-23 for MS. Hopefully, it all works out. The reason we chose it was for all the treatment given that is paid for by the manufacturer. Example, instead of getting MRI every 6 months per insurance, he will go every 6 weeks. This way, we will know what is happening, if it is working etc.

 

[onelilspark]

I just signed up to do a trial for migraines. Very thorough as far as weeding out people with other conditions...need a blood test and everything (also have to take a pregnancy test every month ) It's in Rochester, so for me, it's not a big deal to get to the location for check ups.

 

[CaliforniaDreamin]

Ok, wow. I have found good news. They say on the website that it is inpatient, no cost, compensation and they will pay for all transportation costs for anywhere in the US. So MAYBE, this isn't over.

 

[CaliforniaDreamin]

What Phase of Trial - II or III?

I can't find it! I'll keep looking.

Found it! Phase 2. What does that mean? Is it good or bad?

 

[chloelovesdisney]

Ok, wow. I have found good news. They say on the website that it is inpatient, no cost, compensation and they will pay for all transportation costs for anywhere in the US. So MAYBE, this isn't over.

Really look into what you are getting involved in. That sounds like something they would offer for a Phase 1 study, which means it's something that's only been tested in animals. The majority of things that go through a Phase 1 study never get approved by the FDA for a reason, so just look into it carefully.

 

[dejr_8]

I can't find it! I'll keep looking.

Found it! Phase 2. What does that mean? Is it good or bad?

A PII trial is used mainly to determine the appropriate dosage level to achieve the desired clinical outcome without causing adverse events.

On the downside, it means that IF the drug is successful it is still a minimum of 4 - 5 years away from being a licensed product.

 

[NotUrsula]

I'm thinking that this might be an NIH trial? If so, probably the best thing you can do right now is to contact the physician who most recently treated you for this condition and ask him/her to write a recommendation. In any case, have as much paperwork as possible right in front of you during the phone interview, including names, addresses and phone numbers of your physicians. (Electronic versions are also good, so that you can immediately shoot them via email to the interviewer, but it's OK if you don't have them, because they can get them from your physicians.) Obviously, if your physician doesn't think that you would be a good candidate, then it won't help, but I personally never would want to be in a trial that my physician had not investigated for me first, particularly a medication trial.

It is my understanding that very few patients get into NIH trials on their own. Most of them are recommended as trial subjects by their physicians. (NIH tends to contact well-known specialists when they are recruiting, in order to get the best possible subjects for their trials.)

The good news is that NIH is not as picky about the likelihood of your having a positive outcome. Medical school trials care very much about that because they are trying to impress NIH or some other funding source into giving them more money for further study of the issue -- if the treatment isn't showing a lot of initial success then NIH won't cough up the money. I'm told that NIH is relatively immune to that effect in their own trials.

PS: If you are near Duke, you might want to sign up for their trials database. If anyone is studying something big in your area, it's likely to be Duke. http://medschool.duke.edu/modules/rs_services/index.php?id=9

 

[CaliforniaDreamin]

Thank you all for your help and for being nice. Sometimes I get nervous starting a post on here. Thank goodness it clearly says Phase 2. I didn't know that Phase 1 was animals.
And yes, it is a NIMH clinical trial. I see my therapist tomorrow. I don't see my psychiatrist until July 28. I just hope this works. I have suffered for decades and I'm losing my family day by day. I'm scared. This means hope. And I'm already aware that I could be given a placebo and this would be a huge waste of time. I guess I just need to take things one step at a time and hope things work out.

 

[dejr_8]

Thank you all for your help and for being nice. Sometimes I get nervous starting a post on here. Thank goodness it clearly says Phase 2. I didn't know that Phase 1 was animals.
And yes, it is a NIMH clinical trial. I see my therapist tomorrow. I don't see my psychiatrist until July 28. I just hope this works. I have suffered for decades and I'm losing my family day by day. I'm scared. This means hope. And I'm already aware that I could be given a placebo and this would be a huge waste of time. I guess I just need to take things one step at a time and hope things work out.

Phase I trials ARE performed in humans.

 

[chloelovesdisney]

Thank you all for your help and for being nice. Sometimes I get nervous starting a post on here. Thank goodness it clearly says Phase 2. I didn't know that Phase 1 was animals.
And yes, it is a NIMH clinical trial. I see my therapist tomorrow. I don't see my psychiatrist until July 28. I just hope this works. I have suffered for decades and I'm losing my family day by day. I'm scared. This means hope. And I'm already aware that I could be given a placebo and this would be a huge waste of time. I guess I just need to take things one step at a time and hope things work out.

Oops, sorry if I wasn't clear. It's animals, Phase 1, then 2, then 3, then maybe get approved by the FDA or maybe not. Most drugs tested are not approved for whatever reason, maybe they don't prove to be effective or they are proven to be dangerous. A Phase 1 study is relatively small to test for safety, if that proves okay it moves forward to Phase 2. It's important to remember this is a study, they are testing it to see if it is effective and safe, and as you already know, you could just get placebo.

 

[CaliforniaDreamin]

Phase I trials ARE performed in humans.

I did see that this is not the first test done on humans, but they had a high level of success that they are doing another round. So that makes me feel a lot better. I don't want to be one of the first humans to get this treatment!

This is from the website: Targeting the glutamatergic system to treat depression is a new and promising strategy based on studies at the molecular, synaptic, and neuronal level but also on results of studies conducted in animal models and first clinical studies involving depressed patients.

 

[Shellie722]

I have participated in phase 2, 3, & post market trials for 2 different conditions.

I was part of the Imitrex post-market/long term effects trial when it 1st came out. That was the easiest to get into since at that point the med was FDA aproved already and they were just looking at side affects & long term use.

I was part of a double blind phase 2 study for Amerge and a phase 3 trial for evaluating different dosages and their effectiveness. That one was harder to get in b/c you had to experience at least so many mgraines in a 6 month period and it depended on what other meds you had taken in the past year as well.

I am in a long term extension for BenLysta now. I started it about 6 years ago as part of the first phase 2 study when it had only been tested in 60 people previously. The requirements to be included in it were MUCH stricter than either study I had been part of previously. It involved a 24 hr urine collection, several rounds of blood work, my entire prior medical history, evaluations by my pcp, the nurse overseeing the study, and the rheumatologist who's office was conducting the study locally. When aproved, BenLysta will be the only medication specifically developed to treat lupus and the first lupus treatment aproved by the FDA in over 50 years which made it especially important to be vigilant in the screening process and avoid serious complications in the study patients.

Basically, every study varies in its requirements depending on what it is intended to treat and what phase the study is in. Make sure you are completely 100% honest when talking to the investigators and treatment providers b/c if you're not it can lead to potentially serious harm to yourself as well as inacurate study outcomes which can affect other patients who might recieve the treatment in the future.

 

[clori]

I used to live in walking distance to the Longwood Medical area in Boston and frequently saw ads for various studies. I did one study which was a week on a special low sodium diet (all food was provided and it was the same food each day for 7 days). I had blood work done before and after. There were no drugs involved. I think I made $100 plus saved money on food. Another study I did involved going to a vascular lab for a few hours. They were testing an additive that would be used with some medication but I was a guinny pig for the additive without the meds. My vein collapsed about 3/4 way thru but I still got paid $300 plus several months later was invited to repeat the test for pay.

The 3rd study I did was more dangerous. Before they determined how dangerous ephedra was I took it as part of a weight loss study. I had blood tests and has to wear a heart monitor around the clock as well as have other heart tests done. If there was even a hint of cardiac problems the study would have been stopped. I do not know if I had the real thing or a placebo. I did lose weight but the study also required drinking 8 glasses of water a day, eating healthy and exercising so it may have also been from that. I made $400 for the study. This study was over the course of x weeks with several short dr visits though they were easily scheduled before/after work.

I used all of the study money to help pay for wedding costs such as hair, makeup, nails etc for the bridal party, favors and extra flowers. My kids have done some language and learning studies but none of them involved any medications/invasive procedures. Those were done thru a university.

 

[CaliforniaDreamin]

Ok, more good news. It's a crossover study that last 4 weeks. So one group is given the placebo and the other group is given the real deal for 2 weeks. Then it's switched. So it seems that everyone involved will get the real treatment during the study. I'm just confused because they list study 1, study 2 and study 3. I'm wondering if this is the same thing as Phases. They don't list a timeframe for study 1 but study 2 is 4 weeks and study 3 is six weeks. I have some other questions about prior drug trials (it sounds like you have to be involved in 2 other trials before you get to this one, but I'm not sure. So this may be what eliminates me, as I have never been thru any trials. )