How to choose and get into a trial?

[Lolita]

Hello,
I am new here and was wondering how does one choose and get into that particular trial? Can I simply try to get into.. say the one at Emory and simultaneously try to get into one that might be going on in the Mayo? Just to see if I get turned down with one that I may secure a spot with another?

Does anybody know of anybody who has had the drug at a clinical trial and gotten any better?

What is phase I II, and III mean? Does a single participant if accepted participate in all 3?

Are you required to stay at the hospital or nearby for the duration of the study?

 

[HelenL]

Hi Lolita, welcome to the forum... sorry you find yourself here.

First, you need to have a firm diagnosis, or you won't qualify. And you can apply for different trials, but they all have different criteria; for instance, one may require you to live near the study site, as you may have more invasive studies. Others just want to make sure you can get into the test site every month or so. I don't think any will allow you to be in another study at the same time, as that would skew the results. And you can drop out of any study if you wish... FYI, I'm in the Dex trial, and am now in the Open Label part where I can continue to get the drug (no placebos at this point) for 3 year free.

 

[momap53]

Check out the NEALS (North East ALS Consortium) site for info on Clinical Trials. They list current and upcoming CTs, where they are being held and what the inclusion and exclusion criteria are for each trial. They also have experts that will answer your questions. Like them on face book and have news delivered to your feed or email.

 

[Lolita]

I'm not sure if you're allowed to say..but have you noticed any improvement in the Dex trial? In what ways is Dex supposed to help? Do you think they will offer this drug soon to those who have been diagnosed? Sorry about all the questions...A wee bit worried.

 

[Lolita]

Check out the NEALS (North East ALS Consortium) site for info on Clinical Trials. They list current and upcoming CTs, where they are being held and what the inclusion and exclusion criteria are for each trial. They also have experts that will answer your questions. Like them on face book and have news delivered to your feed or email.

I sure will Deb...Thank you.

 

[HelenL]

I have progressed, but it is slower than many. I don't know yet if I had the placebo or not, but we're all on the real thing now... and haven't seen many changes since then, but there are some.

Best thing to do is to ask your neuro what they would suggest, and remember that the later phases have already been tested for safety.

 

[lgelb]

Phase I=tests in healthy volunteers to ascertain safety, biomarkers, etc. Phase II=limited testing in affected pts, often at multiple doses. Often split into IIa and IIb phases for better dose-finding, etc. Phase III=larger scale version of Phase II and used to obtain FDA/other regulatory agency (ex-US) approval. Usually but not always two of these are required for regulatory approval. As with Phase II, often split into two phases, one for approval, the other for peri-marketing surveillance to further characterize safety, markers of response, etc. Phase IV is post-marketing research, which can garner additional indications, unforeseen safety issues, inform better patient selection, etc. Often a drug will be approved with a Phase IV commitment to the FDA, EMEA or other agency.

It takes years before an agent in Phase III is available for prescription (non-investigational use), even under the fast track/priority review available in ALS and other relatively rare/high unmet need conditions.

 

[rknt50a]

NEALS provides a clinical trial expert who is available at no charge to help people with ALS find and choose among clinical trials.

The clinical trial expert can be reached at -- NEALS located at Massachusetts General Hospital and under that roof there is a lot of ALS expertise. The clinical trial expert line is an outstanding resource imo.

I hope that this might be helpful. Thanks to all pursuing clinical trials.

 

[Lolita]

Thank you all so much. A wealth of information.