NORD Interim Report for POIS Study

[demografx]

Daveman and I contacted NORD to get a copy of Dr. Komisaruk's first interim report (due ~ 6 months after start of study). It should be understood that these interim reports are extensive and in-depth. NORD's MAC reviews them for scientific information, merit and accuracy before approving them. This report was received at the end of April 2015, and approved by the MAC.

As you can understand, these reports are highly confidential until they are publicly published in a journal. But,  NORD includes a request for a brief summary that can be publicly posted.

Here's the public summary for the first interim report. It's written in general terms which is to be expected:

"The IRB applications authorizing our study have been approved, the POIS questionnaire characterizing relevant medical history and symptomatology has been developed, site-tested, and expanded, and will now, upon IRB approval, be distributed to the POIS forum for more extensive response and analysis.

POIS sufferers have been contacted, interviewed, and local POIS persons will be the first to participate in the physiological interventions. The necessary equipment has been obtained, the physiological measurement methods have been developed and are functioning properly, and the necessary fMRI procedures and analysis methods have been developed and are ready to be deployed."

The NORD research grant administrator additionally advised --

"The next report is due on October 25, 2015. The PI has also been granted a no cost extension for a year due to some delays round receiving IRB approval for the study."

Daveman and I will request from NORD the next interim report, due at the end of October 2015.

Demo & Daveman

[G-man]

Thank you demografx, daveman, and bluesbrother for helping make this study a reality

[Outsider]

Daveman and I contacted NORD to get a copy of Dr. Komisaruk's first interim report (due ~ 6 months after start of study). It should be understood that these interim reports are extensive and in-depth. NORD's MAC reviews them for scientific information, merit and accuracy before approving them. This report was received at the end of April 2015, and approved by the MAC.

As you can understand, these reports are highly confidential until they are publicly published in a journal. But,  NORD includes a request for a brief summary that can be publicly posted.

Here's the public summary for the first interim report. It's written in general terms which is to be expected:

"The IRB applications authorizing our study have been approved, the POIS questionnaire characterizing relevant medical history and symptomatology has been developed, site-tested, and expanded, and will now, upon IRB approval, be distributed to the POIS forum for more extensive response and analysis.

POIS sufferers have been contacted, interviewed, and local POIS persons will be the first to participate in the physiological interventions. The necessary equipment has been obtained, the physiological measurement methods have been developed and are functioning properly, and the necessary fMRI procedures and analysis methods have been developed and are ready to be deployed."

The NORD research grant administrator additionally advised --

"The next report is due on October 25, 2015. The PI has also been granted a no cost extension for a year due to some delays round receiving IRB approval for the study."

Daveman and I will request from NORD the next interim report, due at the end of October 2015.

Demo & Daveman

Demo & Daveman
you re the best !

[Colm]

Thanks Guys

[Pianist]

Thank you very much

[FloppyBanana]

Daveman and I contacted NORD to get a copy of Dr. Komisaruk's first interim report (due ~ 6 months after start of study). It should be understood that these interim reports are extensive and in-depth. NORD's MAC reviews them for scientific information, merit and accuracy before approving them. This report was received at the end of April 2015, and approved by the MAC.

As you can understand, these reports are highly confidential until they are publicly published in a journal. But,  NORD includes a request for a brief summary that can be publicly posted.

Here's the public summary for the first interim report. It's written in general terms which is to be expected:

"The IRB applications authorizing our study have been approved, the POIS questionnaire characterizing relevant medical history and symptomatology has been developed, site-tested, and expanded, and will now, upon IRB approval, be distributed to the POIS forum for more extensive response and analysis.

POIS sufferers have been contacted, interviewed, and local POIS persons will be the first to participate in the physiological interventions. The necessary equipment has been obtained, the physiological measurement methods have been developed and are functioning properly, and the necessary fMRI procedures and analysis methods have been developed and are ready to be deployed."

The NORD research grant administrator additionally advised --

"The next report is due on October 25, 2015. The PI has also been granted a no cost extension for a year due to some delays round receiving IRB approval for the study."

Daveman and I will request from NORD the next interim report, due at the end of October 2015.

Demo & Daveman

If the Oct report is only an interim one can you advise when the study is due to finish?
Thanks - FB

[demografx]

FB, We've asked NORD and will let the forum know as soon as we hear back.

Demo, Daveman

[Habibou]

Thank you very much Demo and Daveman for having this level of communication with the medical research team!

[demografx]

<mod edit>

FB, We've asked NORD and will let the forum know as soon as we hear back.

We've asked for an estimate for date of completion.

The good thing is that the complex IRB adjustments are pretty much resolved.

Demo, Daveman

[demografx]

Thank you very much Demo and Daveman for having this level of communication with the medical research team!

You're welcome Habibou!

[Stef]

Hi All,

Delays in the start of a clinical study due to IRB adjustments are entirely routine and occur frequently.

The hassle with IRB  committee reviews is that they usually only take place once/month. So for example, if a question is raised at a meeting in January, the researcher's response is reviewed at the February meeting. As you can imagine, a final committee approval can drag on for several months until everything has been clarified and approved.

A clinical study can't go forward without complete IRB committee approval. There can be no lingering questions, no unresolved issues. Thus, all adjustments that were required (or recommended by Dr. K.) for your POIS study have been made. All issues have been 100% resolved.

Stef

[demografx]

Stef, G-Man, Outsider, Colm, Pianist, FB, Habibou:

THANKS FOR YOUR EXTRA SUPPORT!

[Nightingale]

This is welcome information. Thanks for sharing!

[demografx]

Stef, G-Man, Outsider, Colm, Pianist, FB, Habibou:

THANKS FOR YOUR EXTRA SUPPORT!

and Nightingale !

[demografx]

[From NORD]..."The next report is due on October 25, 2015. The PI has also been granted a no cost extension for a year
due to some delays round receiving IRB approval for the study."...

PI = Principal Investigator (Dr. Komisaruk/Rutgers)

[demografx]

...If I'm not mistaken, soon we can probably expect to get some feedback (basic report) from NORD on or after 25th of October....this was mentioned in earlier post. I'm sure one of the moderators can probably confirm my post to you.

That's correct, less_fogged. An interim progress report from Dr. K. is due around the end of October (this month!). NORD will send demo and Daveman a paragraph (or a few paragraphs) that Dr. K will write specifically for posting here.

Stef

Thanks, Stef!

[Quantum]

Hi Daveman, Demo and Stef,

Any news about the public portion of the October 2015 interim progress report ?

[Stef]

Hi Daveman, Demo and Stef,

Any news about the public portion of the October 2015 interim progress report ?

Hi Quantum and All,

Demo has been keeping up with this. Unfortunately, he's been side-tracked by some personal issues, so I'm answering for him (even though he hasn't asked me to).

Dr. Komisaruk was contacted by NORD (~3 weeks ago) for the interim report. NORD advised demo that they expect to receive it "soon."

A few-weeks delay of a report by a researcher is typical and should not be viewed negatively.  Often, a study is at a point where specific results are pending, and the PI sometimes wants to wait for those results before submitting the report.

Once the report gets to NORD, it then needs to be reviewed and approved by NORD's MAC. That can take another week.

The bottom line is that demo and NORD are in touch about the report. The minute he (and Daveman) receive it, one of them will post it.

Stef

[Habibou]

Thank you very much Stephanie for these detailed information !

[COLM_2]

Thanks for the updates. Look forward to hearing the news !