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Dr Ron Davis on why his NIH proposal was rejected

Sasha

Fine, thank you
Messages
17,863
Location
UK
The Severely Ill, Big Data project costs $1m and involves (ideally) 40 patients @ $25,000 - they will do as many patients as they can with the money they get. It's their first project.

They're also looking for $5m/year for their overall research programme.
 

caledonia

Senior Member
Here's one link to a Eureka project for Epilepsy and some quotes from the page.

"This research was funded by the Exceptional, Unconventional Research Enabling Knowledge Acceleration (EUREKA) program at NIH that supports innovative research with the potential for big impact in biomedical science."

"The goal of the EUREKA program is to provide a means to test high-risk ideas to see if they are worth pursuing further. These kinds of ideas often come from left field and are very creative. Since they are so unique, however, there may not be any existing preliminary data to support the hypothesis or demonstrate feasibility. EUREKA grants provide an opportunity to gather this information,” said Brandy Fureman, Ph.D., program director at NINDS.

http://www.ninds.nih.gov/news_and_events/news_articles/pressrelease_zebrafish_09032013.htm

I don't see where a proposal to study genetics from the guy who had a huge hand in the Human Genome Project (Ron Davis) as well as the guy who won the Nobel prize for discovering DNA (Watson) is at all risky or out there.
 

panckage

Senior Member
Messages
777
Location
Vancouver, BC
@panckage, what special permission for funding are you talking about?
Correct me if I'm wrong, but this study was judged by its merits alone (nothing to do with ME). A study with low statistical power will be rejected. Nothing specific, I just mean that a study with poor statistical power has to have something uniquely important about it to get funded. This decision would have to come fro the higher ups rather than than the lowly reviewers who often have very specific criteria for refusal
 

Hutan

Senior Member
Messages
1,099
Location
New Zealand
@panckage
from the following document
http://www.meaction.net/wp-content/uploads/2015/08/ResponseToNIHRejectionsRonDavis.pdf

The first pre-proposal was for a P01 grant for $1,000,000 per year for 5 years.
1. NIH: It was not clear that the proposal falls within the mission of NINDS since there was no mention of collection of CSF or of analysis of cognitive or other nervous system function of the individuals with ME/CFS/SEID.
NINDS isn't seeing ME/CFS as a disease with systemic effects including significant neurological components.

2. NIH: Everyone agrees that this research needs to be done for ME/CFS/SEID, but that you would be more successful in review if you narrow the focus of the application to focus on the very ill population and appropriate controls (for example) and submit an R01 with a budget of less than $500,000 for any year of the application.
The proposal already focused on the very ill population. The requirement for controls is valid if there was no plan to have controls. NINDS wants the budget to be smaller (ie study to sample fewer people).

3. NIH: There was a lack of clear hypotheses to be tested and many felt there was a lack of detail provided in the proposal.
Lack of clear hypothesis. We've addressed that above. It's possible to interpret the study as having a clear hypothesis. If NINDS wanted to fund this project, it would not be a major problem.​

4. NIH: There was agreement that a large biomarker study is needed in ME /CFS/SEID, but that perhaps there needs to be an RFA that spells out what NIH would like to fund, with agreement between several institutes so that appropriately powered studies would be submitted and provided with sufficient funding to accomplish the studies.

I don't know how many people it was planned to sample. $1 mill for 5 years with a sample cost per person of $25,000 would allow for a well-powered study. NINDS suggests an RFA so that several institutes could together fund a study with the inference that the budget for this study is too big for just NINDS. It remains to be seen if an RFA is made.
The second pre-proposal was for an R01 grant for $800,000 per year for 5 years.
NIH: “I am writing to inform you that the NINDS Extramural Science Committee did not approve your request to submit an R01 application with a budget over $500,000 to NINDS. The Committee was concerned that the grant does not fall in the NINDS mission since it will measure markers and biomarkers in the peripheral blood from individuals with ME/CFS and there are no neurological outcomes in the grant. They also suggested that the application is more appropriate for NIAID, so I suggest you contact Program staff at NIAID to discuss whether or not the application is appropriate for their Institute.”
Again, it seems NINDS does not want to take responsibility for ME/CFS. It suggests funding be sought from NIAID.


So, the applications were for $800,000 or $1 million per year for five years which would result in a large sample. Panckage, it does not seem that the power of the study was a problem.

(edited to fix formatting)
 
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Gingergrrl

Senior Member
Messages
16,171
I don't see where a proposal to study genetics from the guy who had a huge hand in the Human Genome Project (Ron Davis) as well as the guy who won the Nobel prize for discovering DNA (Watson) is at all risky or out there.

@caledonia brilliantly said and I agree. @Hutan also agree with everything you said, just too lazy to backtrack and quote on my phone but all brilliant!
 

Snow Leopard

Hibernating
Messages
5,902
Location
South Australia
Correct me if I'm wrong, but this study was judged by its merits alone (nothing to do with ME). A study with low statistical power will be rejected. Nothing specific, I just mean that a study with poor statistical power has to have something uniquely important about it to get funded. This decision would have to come fro the higher ups rather than than the lowly reviewers who often have very specific criteria for refusal

This seems like a catch-22.
No money for a larger study with more statistical power, so they apply for less money. But rejected due to lack of statistical power.

Meanwhile, lack of hypothesis generation studies leads to a lack of ideas to base further studies.

Pilot studies like these are the bottleneck in ME/CFS research. If more speculative pilot studies were funded, we'd see at least a two fold increase in funding, when the follow-on studies are funded...

ME/CFS is the exception, not the norm. We need leadership. We need special attention to kick-start the field and build research capacity.
 

Bob

Senior Member
Messages
16,455
Location
England (south coast)
Great news! This might have been posted elsewhere, but i've just received this by email from OMF...

OMF said:
Phase 1 of the End ME/CFS Project is fully funded!
$1 million ME/CFS Severely ill Big Data Study

We are thrilled to announce that we just received $350K from a tremendously generous anonymous donor for the ME/CFS Severely ill Big Data Study. This adds to our $500K and other incredible donations that we have received from generous and engaged donors via donations, recurring donations, crowdfunding efforts and fundraisers all over the world.
We will continue our efforts towards funding the next phase of the End ME/CFS project
and in bringing thought leaders together in global collaboration.

Now let's find a biomarker!
(check out details on our website)

It takes a community to make this happen and we are grateful beyond words
for your encouragement, engagement and support.
THANK YOU!


With much appreciation and HOPE!

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Linda

Linda Tannenbaum
Executive Director
Open Medicine Foundation
Collaborating to fast track answers
www.openmedicinefoundation.org