What Does Follica's 'Registration Study' and 'Data Read-Out' Mean?

[Breyfogle]

• Follica plans to initiate a registration study in the second half of 2016, with data read-out in 2017.
• If the data are favourable, Follica would potentially plan to seek FDA clearance in 2017, with commercial release to follow as soon as 2018.

I'm only familiar with the phases of a clinical trial. Are the registration study and data read-out typical procedures for successful clinical trials? Hoping someone here is familiar with the process.

 

[Noisette]

[h=3]Registry Studies: Why and How[/h] There is only one difference between registry studies and clinical studies: registry studies are observational and clinical studies are investigational. (When clinical studies are randomized they are called randomized clinical studies or RCTs.) To put it another way, in a registry study we tell the physician to treat the condition however they want—as sponsors, we are passive observers; in a clinical study we instruct the investigator to treat the condition in a certain manner—we are active researchers.
There is another, inevitable, feature of registry studies that I want to point out. The words "effectiveness" and "efficacy" are often misused, even by FDA. Effectiveness refers to how well a device performs as intended in the general population of patients and the general chaos of clinical practice. Effectiveness is measured in registry studies. Efficacy refers to how well a device performs in a setting of carefully selected patients and a carefully controlled protocol. Efficacy is measured in clinical studies.

 

[Breyfogle]

Wow. That solves that. Many thanks to the mysterious Noisette from France!

 

[farkhairloss]

Registry Studies: Why and How

There is only one difference between registry studies and clinical studies: registry studies are observational and clinical studies are investigational. (When clinical studies are randomized they are called randomized clinical studies or RCTs.) To put it another way, in a registry study we tell the physician to treat the condition however they want—as sponsors, we are passive observers; in a clinical study we instruct the investigator to treat the condition in a certain manner—we are active researchers.
There is another, inevitable, feature of registry studies that I want to point out. The words "effectiveness" and "efficacy" are often misused, even by FDA. Effectiveness refers to how well a device performs as intended in the general population of patients and the general chaos of clinical practice. Effectiveness is measured in registry studies. Efficacy refers to how well a device performs in a setting of carefully selected patients and a carefully controlled protocol. Efficacy is measured in clinical studies.

Noisette has been around a while on the other forum. You know the one where you can only say what they want you to say. And they are hell bent on pushing hair transplants. Welcome Noisette

 

[Pray The Bald Away]

Noisette has been around a while on the other forum. You know the one where you can only say what they want you to say. And they are hell bent on pushing hair transplants. Welcome Noisette

I feel like everyone has migrated to HairLossTalk.com. The other forum seems practically empty. I wish Desmond would move here too.

 

[Noisette]

Wow. That solves that. Many thanks to the mysterious Noisette from France!

Hahaha. Thanks bro !

Noisette has been around a while on the other forum. You know the one where you can only say what they want you to say. And they are hell bent on pushing hair transplants. Welcome Noisette

Many thanks for your kind words... Thank you ! haha, yes the one where Hellouser couldn't have a thread in order to send / fund him to the 9th World congress hair research.

I feel like everyone has migrated to HairLossTalk.com. The other forum seems practically empty. I wish Desmond would move here too.

Yes I wish too, Desmond is a great guy

 

[hellouser]

I feel like everyone has migrated to HairLossTalk.com. The other forum seems practically empty. I wish Desmond would move here too.

Good. Spencer Kobren and his forum moderators have no respect for it's members. Furthermore, his outrageous fees to slap his name on a hair transplant doctors 'credibility' is very telling of where his efforts are... hint; IT'S NOT A CURE.

All of his lies, censorship and disregard for any real push for a cure or even basic news on the state of hair loss research is embarrassing. We even tried to pitch and pay for ALL of his expenses to get him to South Korea's Hair Congress 2 years ago and he declined. When we tried to setup a fund ourselves, Winston locked all the threads and banned members from being able to openly comment on the forum.

I even caught Winston lying about this when he denied it:

 

[distracted]

So then why does Desmond still post there? This forum has better discussions and, for the most part, has cutting edge news posted first. But that forum does have some pretty knowledgable posters. Here, we just mainly have Swoop to pass judgements on treatments, but he posts on both forums...We needa poach some of the knowledgable posters from the other forum!

 

[buckthorn]

Hahaha. Thanks bro !



Many thanks for your kind words... Thank you ! haha, yes the one where Hellouser couldn't have a thread in order to send / fund him to the 9th World congress hair research.


Yes I wish too, Desmond is a great guy

NOISETTE!!! I know you from the other forum. I don't disclose who I am, but it's good to have you here!! Now, CURE US. :mrgreen:

 

[I.D WALKER]

If he's as rich as he claims and as bored as he claims, why doesn't he quit?

Narcissists rarely quit because their vanity and high sense of self importance demands daily affirmation.

 

[hellouser]

Narcissists rarely quit because their vanity and high sense of self importance demands daily affirmation.

Positional Good Theory, in full effect. Spencer Kobren only know's his privilege as long as he's got bottom-feeding baldites like us. Yin and yang essentially.

 

[I.D WALKER]

My aquarium usually looks better when I add bottom feeders. It's interesting how they generally appear to fare better the more they are **** on.
Kind of a shame we can't say the same. Reverse PGT?

 

[Norwood One]

When I first wanted to join a hair loss forum, it was between BTT and HairLossTalk.com. Realized quickly BTT was a massive plug for getting hair plugs. Joined here instead. Pretty good decision.

 

[I.D WALKER]

I'll take special liberties and put in a positive plug on HairLossTalk.com's behalf just to say

that I think you made a massively good decision Norwood. -)

We'll stronger now then before.