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Anomie
03-30-2012, 09:01 AM
It looks like all of the info relating to the vx 661 trials has been removed from that girls blog shortly after I posted the link on another thread last night. That thread broke down so I started a new one here.
MamaScarlett, if you read this will you please post the link to the cff press release concerning the vx 809 trials. The only thing I could find on their website from 2012 was about the release of kalydeco.
Thanks

Anomie
03-30-2012, 09:01 AM
It looks like all of the info relating to the vx 661 trials has been removed from that girls blog shortly after I posted the link on another thread last night. That thread broke down so I started a new one here.
MamaScarlett, if you read this will you please post the link to the cff press release concerning the vx 809 trials. The only thing I could find on their website from 2012 was about the release of kalydeco.
Thanks

mamaScarlett
03-30-2012, 09:57 AM
http://www.cff.org/aboutCFFoundation/Publications/connections/March2012/FDA-Approval-of-Kalydeco.cfm


No problem!

mamaScarlett
03-30-2012, 09:57 AM
http://www.cff.org/aboutCFFoundation/Publications/connections/March2012/FDA-Approval-of-Kalydeco.cfm


No problem!

Aboveallislove
03-30-2012, 11:55 AM
It seems to be working again--the links are now showing in initial topic discussion.

Aboveallislove
03-30-2012, 11:55 AM
It seems to be working again--the links are now showing in initial topic discussion.

musclemania70
03-30-2012, 02:29 PM
The press release is not specific enough to make judgements about the status of the 809 or 661. As usual, they are very vague and don't go into detail. I suppose only Vertex is going to be the press release that we want to see. They will be more specific about the drugs and their progress. Interesting why the information on her blog was removed... I suppose if you agree not to publicize results, then she was in error.

musclemania70
03-30-2012, 02:29 PM
The press release is not specific enough to make judgements about the status of the 809 or 661. As usual, they are very vague and don't go into detail. I suppose only Vertex is going to be the press release that we want to see. They will be more specific about the drugs and their progress. Interesting why the information on her blog was removed... I suppose if you agree not to publicize results, then she was in error.

mamaScarlett
03-30-2012, 04:35 PM
Yes it is vague which is irritating.
But there is no information about the trial being canceled whatsoever, as was recently posted here. From the paragraph on 809 and 661:

Later this year we expect to have results from the second part of the Phase 2 trial of Kalydeco and VX-809 in those with the Delta F508 mutation. This is a very important trial; nearly 90 percent of people with CF have the Delta F508 mutation.
Results from the first part of this Phase 2 trial showed that those who received the two drugs together had a decrease in sweat chloride levels — a sign that the combination treatment is having an effect on the root cause of the disease.
Vertex is also testing Kalydeco together with another potential drug, VX-661, in people the most common mutation. These studies could lay the groundwork for future clinical research using a combination therapy approach.

mamaScarlett
03-30-2012, 04:35 PM
Yes it is vague which is irritating.
But there is no information about the trial being canceled whatsoever, as was recently posted here. From the paragraph on 809 and 661:

Later this year we expect to have results from the second part of the Phase 2 trial of Kalydeco and VX-809 in those with the Delta F508 mutation. This is a very important trial; nearly 90 percent of people with CF have the Delta F508 mutation.
Results from the first part of this Phase 2 trial showed that those who received the two drugs together had a decrease in sweat chloride levels — a sign that the combination treatment is having an effect on the root cause of the disease.
Vertex is also testing Kalydeco together with another potential drug, VX-661, in people the most common mutation. These studies could lay the groundwork for future clinical research using a combination therapy approach.

hmw
03-30-2012, 04:50 PM
I think you do have to agree not to share info that specific (i.e. fev1). You aren't even told what your numbers are when they are done at clinic. And it does kind of make sense to me, as frustrating as it is (I am just as curious as everyone else!) If everyone is sharing their info it starts taking away from objectivity of the process. And really, she has no idea if she is on drug or placebo, experiencing legitimate therapeutic effects from medication or not. Oh how I hope she is- odds are definitely in her favor.

Anyway, I think clinical trials have always been that way though re sharing info... it's not something new.

hmw
03-30-2012, 04:50 PM
I think you do have to agree not to share info that specific (i.e. fev1). You aren't even told what your numbers are when they are done at clinic. And it does kind of make sense to me, as frustrating as it is (I am just as curious as everyone else!) If everyone is sharing their info it starts taking away from objectivity of the process. And really, she has no idea if she is on drug or placebo, experiencing legitimate therapeutic effects from medication or not. Oh how I hope she is- odds are definitely in her favor.

Anyway, I think clinical trials have always been that way though re sharing info... it's not something new.

hmw
03-30-2012, 04:54 PM
I agree, mamaScarlett. All the people who have 'sources' telling them that once 2b is done that 809 is being scrapped clearly have sources speaking out of turn- even if they know it's fact, they aren't supposed to be leaking this info prior to the official Vertex press release, and it drives me crazy that it will remain conjecture for some time yet.

I don't think there is any question that the 2b will be finished- those assured that THIS trial is not being scrapped are absolutely correct. Have THEY been told anything about a phase 3 is the real question.

hmw
03-30-2012, 04:54 PM
I agree, mamaScarlett. All the people who have 'sources' telling them that once 2b is done that 809 is being scrapped clearly have sources speaking out of turn- even if they know it's fact, they aren't supposed to be leaking this info prior to the official Vertex press release, and it drives me crazy that it will remain conjecture for some time yet.

I don't think there is any question that the 2b will be finished- those assured that THIS trial is not being scrapped are absolutely correct. Have THEY been told anything about a phase 3 is the real question.

mamaScarlett
03-30-2012, 05:32 PM
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>hmw</b></i> I agree, mamaScarlett. All the people who have 'sources' telling them that once 2b is done that 809 is being scrapped clearly have sources speaking out of turn- even if they know it's fact, they aren't supposed to be leaking this info prior to the official Vertex press release, and it drives me crazy that it will remain conjecture for some time yet. I don't think there is any question that the 2b will be finished- those assured that THIS trial is not being scrapped are absolutely correct. Have THEY been told anything about a phase 3 is the real question.</end quote>
Exactly. Everyone's vagueness is driving me nuts!
Here's my question, and perhaps it sounds elementary, but why in the world would they scrap this and not proceed with a phase 3 when they are saying this about this drug?-
"<span>Results from the first part of this Phase 2 trial showed that those who received the two drugs together had a decrease in sweat chloride levels &mdash; a sign that the combination treatment is having an effect on the root cause of the disease. "
???

mamaScarlett
03-30-2012, 05:32 PM
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>hmw</b></i> I agree, mamaScarlett. All the people who have 'sources' telling them that once 2b is done that 809 is being scrapped clearly have sources speaking out of turn- even if they know it's fact, they aren't supposed to be leaking this info prior to the official Vertex press release, and it drives me crazy that it will remain conjecture for some time yet. I don't think there is any question that the 2b will be finished- those assured that THIS trial is not being scrapped are absolutely correct. Have THEY been told anything about a phase 3 is the real question.</end quote>
Exactly. Everyone's vagueness is driving me nuts!
Here's my question, and perhaps it sounds elementary, but why in the world would they scrap this and not proceed with a phase 3 when they are saying this about this drug?-
"<span>Results from the first part of this Phase 2 trial showed that those who received the two drugs together had a decrease in sweat chloride levels &mdash; a sign that the combination treatment is having an effect on the root cause of the disease. "
???

Anomie
03-30-2012, 06:20 PM
Its because the average drop in sweat chloride was less than they had hoped for even though some patients experienced significant decreases. I'm just speculating here but they may be planning to scrap 809 after the phase 2b trial if vx 661 out performs in its current phase 2a trial. This is obviously not something they'd want to share with the general public but it would make sense. I wish that who ever started this rumor would come forward and share their source or there's really no point in discussing it anymore.

Anomie
03-30-2012, 06:20 PM
Its because the average drop in sweat chloride was less than they had hoped for even though some patients experienced significant decreases. I'm just speculating here but they may be planning to scrap 809 after the phase 2b trial if vx 661 out performs in its current phase 2a trial. This is obviously not something they'd want to share with the general public but it would make sense. I wish that who ever started this rumor would come forward and share their source or there's really no point in discussing it anymore.

Anomie
03-30-2012, 06:29 PM
BTW: All of the posts from the girl's blog still appear to be deleted. If you have found them then please post the link.

Anomie
03-30-2012, 06:29 PM
BTW: All of the posts from the girl's blog still appear to be deleted. If you have found them then please post the link.

hmw
03-31-2012, 12:10 AM
Phase 2a of the 809/770 trial showed the limited reduction in sodium chloride levels, etc- that is the press result that resulted in vertex stock dropping, if people remember due to results not meeting expectations. Phase 2b (the phase wrapping up now) involved a longer period on the meds and in larger doses to see if a better result would be obtained, enough to result in significant clinical results ...improved pulmonary function, reduced sweat tests, etc. Problems have been encountered with 809 and 770 interacting- this is known, not conjecture- whether they can overcome this I have no idea.

The major problem with waiting for this phase of 661 to decide which drug to move forward with would be that it has JUST started and is not estimated to be finished until August 2013, so hopefully they will be going by other data in making their decision.

hmw
03-31-2012, 12:10 AM
Phase 2a of the 809/770 trial showed the limited reduction in sodium chloride levels, etc- that is the press result that resulted in vertex stock dropping, if people remember due to results not meeting expectations. Phase 2b (the phase wrapping up now) involved a longer period on the meds and in larger doses to see if a better result would be obtained, enough to result in significant clinical results ...improved pulmonary function, reduced sweat tests, etc. Problems have been encountered with 809 and 770 interacting- this is known, not conjecture- whether they can overcome this I have no idea.

The major problem with waiting for this phase of 661 to decide which drug to move forward with would be that it has JUST started and is not estimated to be finished until August 2013, so hopefully they will be going by other data in making their decision.

Anomie
03-31-2012, 12:37 AM
Hmmm. So I'm guessing they won't know if 661 will reactly badly with 770 until they try upping the dose in the second phase of the trial. Or do they?

Anomie
03-31-2012, 12:37 AM
Hmmm. So I'm guessing they won't know if 661 will reactly badly with 770 until they try upping the dose in the second phase of the trial. Or do they?

musclemania70
03-31-2012, 01:02 AM
Vertex said 661 did not have the problems that were being seen with 809. That's what the man said. I didn't get his card. He said 809 will be continuing but if the 661 shows to be more effective at higher levels then they are scrapping the 809. That is exactly what he said. They are going to continue with the 809 right now because they need to finish the trial and have complete results. They don't want people on 809 giving up and throwing in the towel when they NEED THE DATA.
I think this all makes sense. Vertex holds the cards and we can't see 'em. CFF isn't gonna fold either.

musclemania70
03-31-2012, 01:02 AM
Vertex said 661 did not have the problems that were being seen with 809. That's what the man said. I didn't get his card. He said 809 will be continuing but if the 661 shows to be more effective at higher levels then they are scrapping the 809. That is exactly what he said. They are going to continue with the 809 right now because they need to finish the trial and have complete results. They don't want people on 809 giving up and throwing in the towel when they NEED THE DATA.
I think this all makes sense. Vertex holds the cards and we can't see 'em. CFF isn't gonna fold either.

Anomie
03-31-2012, 03:17 AM
Thank you for clearing that all up.

Anomie
03-31-2012, 03:17 AM
Thank you for clearing that all up.

Kristen
03-31-2012, 09:56 AM
I was wondering if she was going to have to delete her blog. My understanding is that people in a clinical trial can't share that info in a public forum, which is why people in clinical trials have always said, "PM me if you want more info" on here.

Kristen
03-31-2012, 09:56 AM
I was wondering if she was going to have to delete her blog. My understanding is that people in a clinical trial can't share that info in a public forum, which is why people in clinical trials have always said, "PM me if you want more info" on here.

Anomie
03-31-2012, 03:35 PM
Yeah, they don't want their investors to see what people are saying about the new drugs until they've verified everything and are ready to release a statement.

Anomie
03-31-2012, 03:35 PM
Yeah, they don't want their investors to see what people are saying about the new drugs until they've verified everything and are ready to release a statement.

hmw
03-31-2012, 07:30 PM
We had our cf education day at our hospital and a Vertex rep was there. I asked her what, if anything, she could tell us about the combo trials and when we were going to hear official news. She was, predictably, only able to tell us what we all already know; that they will continue forward with the drug that proves more effective of the two. That is not new information by any means if you attended the conferences held this fall/winter or listened to the podcasts of them etc. The press release containing the results of the 2b trial is expected to come this summer, also nothing new. Timetable 2016 if all goes perfect for 809 (pipe dream?), as repeated by the CFF person we had speak today. Nothing new.

She DID say that even if anyone at Vertex knew anything more than this, everyone working there signs agreements that they will not disclose this information. People in trials sign agreements that they will not disclose information. Doctors, clinical coordinators, nurses, etc involved in triala ALL sign this stuff- in other words, none of these 'sources' giving any information other than what is already info released by the CFF or by Vertex are supposed to be doing so and not only is it jeopardizing an individuals participation in the trial, if there's enough of it, it jeopardizes the ENTIRE TRIAL. She speculates that a lot of what's floating around is intentional vagueness colored by the perception of whoever hears it. Anyway, I sure didn't like the sound of people not being able to keep their mouths shut being able to jeopardize an entire trial process- for any med. I understand excitement (this waiting is driving me nuts!) but there's a reason it's all set up the way it is.

hmw
03-31-2012, 07:30 PM
We had our cf education day at our hospital and a Vertex rep was there. I asked her what, if anything, she could tell us about the combo trials and when we were going to hear official news. She was, predictably, only able to tell us what we all already know; that they will continue forward with the drug that proves more effective of the two. That is not new information by any means if you attended the conferences held this fall/winter or listened to the podcasts of them etc. The press release containing the results of the 2b trial is expected to come this summer, also nothing new. Timetable 2016 if all goes perfect for 809 (pipe dream?), as repeated by the CFF person we had speak today. Nothing new.

She DID say that even if anyone at Vertex knew anything more than this, everyone working there signs agreements that they will not disclose this information. People in trials sign agreements that they will not disclose information. Doctors, clinical coordinators, nurses, etc involved in triala ALL sign this stuff- in other words, none of these 'sources' giving any information other than what is already info released by the CFF or by Vertex are supposed to be doing so and not only is it jeopardizing an individuals participation in the trial, if there's enough of it, it jeopardizes the ENTIRE TRIAL. She speculates that a lot of what's floating around is intentional vagueness colored by the perception of whoever hears it. Anyway, I sure didn't like the sound of people not being able to keep their mouths shut being able to jeopardize an entire trial process- for any med. I understand excitement (this waiting is driving me nuts!) but there's a reason it's all set up the way it is.

Anomie
03-31-2012, 09:06 PM
The 28 day VX 661 trial is now complete and the results should be out by this summer. It was a really smart move by the foundation to have a back up to the vx 809.

Anomie
03-31-2012, 09:06 PM
The 28 day VX 661 trial is now complete and the results should be out by this summer. It was a really smart move by the foundation to have a back up to the vx 809.

hmw
03-31-2012, 11:34 PM
The current vx 661 trial has just started and is not estimated to be completed till August 2013.
The initial 28 day monotherapy w/ 661 is just the beginning. Depending on whatever they are looking for, it will go on to the next part of the trial- 28 more days of cotherapy with Kalydeco. Then of course is the information gathering etc and it is still recruiting etc.
http://clinicaltrials.gov/ct2/show/study/NCT01531673?term=Vx-661&rank=1

hmw
03-31-2012, 11:34 PM
The current vx 661 trial has just started and is not estimated to be completed till August 2013.
The initial 28 day monotherapy w/ 661 is just the beginning. Depending on whatever they are looking for, it will go on to the next part of the trial- 28 more days of cotherapy with Kalydeco. Then of course is the information gathering etc and it is still recruiting etc.
http://clinicaltrials.gov/ct2/show/study/NCT01531673?term=Vx-661&rank=1

mamaScarlett
04-01-2012, 12:18 PM
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>hmw</b></i> The current vx 661 trial has just started and is not estimated to be completed till August 2013. The initial 28 day monotherapy w/ 661 is just the beginning. Depending on whatever they are looking for, it will go on to the next part of the trial- 28 more days of cotherapy with Kalydeco. Then of course is the information gathering etc and it is still recruiting etc. http://clinicaltrials.gov/ct2/show/study/NCT01531673?term=Vx-661&rank=1</end quote>

Thank you Harriet for your<strong> accurate information</strong>!
It is imprortant to remember to be accurate to the T-even if a drug may or may not pan out...we need eligible patients to be in the trials to get us all closer to a drug that will help many of us.

mamaScarlett
04-01-2012, 12:18 PM
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>hmw</b></i> The current vx 661 trial has just started and is not estimated to be completed till August 2013. The initial 28 day monotherapy w/ 661 is just the beginning. Depending on whatever they are looking for, it will go on to the next part of the trial- 28 more days of cotherapy with Kalydeco. Then of course is the information gathering etc and it is still recruiting etc. http://clinicaltrials.gov/ct2/show/study/NCT01531673?term=Vx-661&rank=1</end quote>

Thank you Harriet for your<strong> accurate information</strong>!
It is imprortant to remember to be accurate to the T-even if a drug may or may not pan out...we need eligible patients to be in the trials to get us all closer to a drug that will help many of us.

Anomie
04-01-2012, 05:29 PM
All that I said was that the initial 28 day trial is complete and it is since it began at the beginning of march. I looked at the clinical trials website and saw August, 2013 and thought that was this summer. Sorry it was late and I was tired but I'm sure they'll have some kind of statement on vx 661 as we get closer to the annual conference.

Why don't you try checking your tone before you go off snapping at everyone on here!

Anomie
04-01-2012, 05:29 PM
All that I said was that the initial 28 day trial is complete and it is since it began at the beginning of march. I looked at the clinical trials website and saw August, 2013 and thought that was this summer. Sorry it was late and I was tired but I'm sure they'll have some kind of statement on vx 661 as we get closer to the annual conference.

Why don't you try checking your tone before you go off snapping at everyone on here!

musclemania70
04-01-2012, 11:08 PM
um....what? lets be friends.

musclemania70
04-01-2012, 11:08 PM
um....what? lets be friends.

Incomudrox
04-02-2012, 12:25 AM
I didn't read every comment in here, but no one can claim their information is any accurate than anyone else's. Its all a matter of opinion and if someone else agrees with someone else then to you it will appear right in that person's eyes.. If anyone wants to start or continue an argument I can lock this thread so that no one can be a keyboard warrior. No hostility healthy debate however is fine.

Incomudrox
04-02-2012, 12:25 AM
I didn't read every comment in here, but no one can claim their information is any accurate than anyone else's. Its all a matter of opinion and if someone else agrees with someone else then to you it will appear right in that person's eyes.. If anyone wants to start or continue an argument I can lock this thread so that no one can be a keyboard warrior. No hostility healthy debate however is fine.

LouLou
04-02-2012, 12:34 AM
<div class="FTQUOTE"><begin quote><em>Originally posted by: <strong>Anomie</strong></em> Yeah, they don't want their investors to see what people are saying about the new drugs until they've verified everything and are ready to release a statement.</end quote>
BINGO!
And as Harriett mentioned it can jepeordize a trial because it can dilute the data by altering people's ACCURATE portayal of results based on what one participant hears another participant say. Additionally it could unblind aparticipant as it could give them the feeling that they know without a shadow of a doubt whether or not they are on drug or not and for this they are unblinded and can be asked to leave the study. Delays like this will delay the trial finish date.

LouLou
04-02-2012, 12:34 AM
<div class="FTQUOTE"><begin quote><em>Originally posted by: <strong>Anomie</strong></em> Yeah, they don't want their investors to see what people are saying about the new drugs until they've verified everything and are ready to release a statement.</end quote>
BINGO!
And as Harriett mentioned it can jepeordize a trial because it can dilute the data by altering people's ACCURATE portayal of results based on what one participant hears another participant say. Additionally it could unblind aparticipant as it could give them the feeling that they know without a shadow of a doubt whether or not they are on drug or not and for this they are unblinded and can be asked to leave the study. Delays like this will delay the trial finish date.

Anomie
04-02-2012, 04:03 AM
Its just that Harriet had already corrected my mistake and I didn't appreciate that passive-agressive comment about giving inacurate info and verifying my facts before I post just because I got one little date screwed up. Its like when someone says something snobby about you to someone else but loud enough so that you can hear it.

Anomie
04-02-2012, 04:03 AM
Its just that Harriet had already corrected my mistake and I didn't appreciate that passive-agressive comment about giving inacurate info and verifying my facts before I post just because I got one little date screwed up. Its like when someone says something snobby about you to someone else but loud enough so that you can hear it.

hmw
04-02-2012, 10:56 AM
Something I found really surprising- as well as frustrating- was also part of the presentation by our center director the other day. He mentioned that the recruitment process for one of the recent trials took a YEAR and they were only looking for a couple hundred people. Now- I don't think think it was one of the g551d trials, in which case due to the limited population that would qualify, it make more sense that it would take more time to find enough people to participate. Lauren? We're you there for this presentation by Dr. L to remember which trial he was referring to?

Anyway- if recruitment didn't take so long, imagine how much faster these phase 2's could be finished- everyone could start and finish right in the initial months of the trial beginning rather than it taking a year+ just to finish the part where people are actually taking the meds.

Thoughts about WHY this happens? Are centers not being proactive in encouraging their patients to participate or getting involved in the trial process themselves? What is the mindset of more of the patients out there? We all want more treatments and this is the only way to get them.

hmw
04-02-2012, 10:56 AM
Something I found really surprising- as well as frustrating- was also part of the presentation by our center director the other day. He mentioned that the recruitment process for one of the recent trials took a YEAR and they were only looking for a couple hundred people. Now- I don't think think it was one of the g551d trials, in which case due to the limited population that would qualify, it make more sense that it would take more time to find enough people to participate. Lauren? We're you there for this presentation by Dr. L to remember which trial he was referring to?

Anyway- if recruitment didn't take so long, imagine how much faster these phase 2's could be finished- everyone could start and finish right in the initial months of the trial beginning rather than it taking a year+ just to finish the part where people are actually taking the meds.

Thoughts about WHY this happens? Are centers not being proactive in encouraging their patients to participate or getting involved in the trial process themselves? What is the mindset of more of the patients out there? We all want more treatments and this is the only way to get them.

ashleydog
04-02-2012, 11:19 AM
recruitment for any clinical trial can take a long time. They are trying to use a patient population that is as similar as possible. So patients would need not only the same genotype, but there is generally a specified FEV1 range. Other medications that may either interact with the test medication or affect the results have to be ruled out. a patients history needs to be somewhat stable to prove that the new med is responsible for any improvement or decline. Different trials have different requirements. I was in an inhaled antibiotic trial where the requirements were so defined it took the team months to find participants, even though many people came to be screened for it.

In addition to all that, the vertex trials are very time intensive. Since it is an 18 and older trial, many adults may have trouble fitting it into thier schedule.

All that being said, I think all clinical trials are incredibly valuable and one of the reasons I am as old as I am (37) and doing as well as I am. I would rework my schedule to participate in as much research as I can.

one other reason recruitment may take a while, is that both the centers involved and the drug companies want to be sure there are no mistakes or issues. When a drug is first introduced to the CF population, it needs to be done slowly, until the relative saftey of the drug is more well known. You wouldn't want to take an unproven drug and give it to a large population all at once, if there were bad consequences they would have just been multiplied.

hope that helps, and THIS IS ALL SPECULATION I don't have any inside information that I am basing any thing on, just my own experience fom life and my job.

ashleydog
04-02-2012, 11:19 AM
recruitment for any clinical trial can take a long time. They are trying to use a patient population that is as similar as possible. So patients would need not only the same genotype, but there is generally a specified FEV1 range. Other medications that may either interact with the test medication or affect the results have to be ruled out. a patients history needs to be somewhat stable to prove that the new med is responsible for any improvement or decline. Different trials have different requirements. I was in an inhaled antibiotic trial where the requirements were so defined it took the team months to find participants, even though many people came to be screened for it.

In addition to all that, the vertex trials are very time intensive. Since it is an 18 and older trial, many adults may have trouble fitting it into thier schedule.

All that being said, I think all clinical trials are incredibly valuable and one of the reasons I am as old as I am (37) and doing as well as I am. I would rework my schedule to participate in as much research as I can.

one other reason recruitment may take a while, is that both the centers involved and the drug companies want to be sure there are no mistakes or issues. When a drug is first introduced to the CF population, it needs to be done slowly, until the relative saftey of the drug is more well known. You wouldn't want to take an unproven drug and give it to a large population all at once, if there were bad consequences they would have just been multiplied.

hope that helps, and THIS IS ALL SPECULATION I don't have any inside information that I am basing any thing on, just my own experience fom life and my job.

hmw
04-02-2012, 12:11 PM
Those are all excellent points. I really hadn't thought of the implications of giving a phase 2 med to all the trial participants all at once and what could happen if the med did not prove safe or well tolerated. Starting with fewer at a time and collecting data as you go- even though the waiting is hard! does give the information in a safer way.

I didn't get the impression you were trying to give any kind of inside information at all. :-) It's just common sense based on how the trial process works. I took more time to read carefully through the allowing/excluding criteria for some of the trials I am particularly interested in on the clinicaltrials.gov site and you are right, it takes a lot of factors to line up just right.

hmw
04-02-2012, 12:11 PM
Those are all excellent points. I really hadn't thought of the implications of giving a phase 2 med to all the trial participants all at once and what could happen if the med did not prove safe or well tolerated. Starting with fewer at a time and collecting data as you go- even though the waiting is hard! does give the information in a safer way.

I didn't get the impression you were trying to give any kind of inside information at all. :-) It's just common sense based on how the trial process works. I took more time to read carefully through the allowing/excluding criteria for some of the trials I am particularly interested in on the clinicaltrials.gov site and you are right, it takes a lot of factors to line up just right.

cindylou
04-02-2012, 03:00 PM
I think the requirements of the trial make it hard for a lot of people to enter. I know I was offered the chance to do the original phase 3 Kalydeco trial, and really wanted to, but you have to be antibiotic-free for several weeks beforehand AND give up hypertonic saline. I felt like, at the time, my health was unstable enough that I wasn't comfortable giving up one of my "powerhouse meds" (hypertonic) and risking the chance of a placebo. I am getting ready to start Kalydeco later this week (yay!) and I just barely got off the phone with a study coordinator after we decided that I won't qualify for the Kalydeco data-collecting study, either... because I got out of the hospital too recently.

So yep, it's definitely tough to meet all the criteria!

cindylou
04-02-2012, 03:00 PM
I think the requirements of the trial make it hard for a lot of people to enter. I know I was offered the chance to do the original phase 3 Kalydeco trial, and really wanted to, but you have to be antibiotic-free for several weeks beforehand AND give up hypertonic saline. I felt like, at the time, my health was unstable enough that I wasn't comfortable giving up one of my "powerhouse meds" (hypertonic) and risking the chance of a placebo. I am getting ready to start Kalydeco later this week (yay!) and I just barely got off the phone with a study coordinator after we decided that I won't qualify for the Kalydeco data-collecting study, either... because I got out of the hospital too recently.

So yep, it's definitely tough to meet all the criteria!

musclemania70
04-02-2012, 03:53 PM
You don't have to give up Hypertonic Saline for 661 part A.

musclemania70
04-02-2012, 03:53 PM
You don't have to give up Hypertonic Saline for 661 part A.