You may recall my letter to the NCI of December 5th.  It is posted here.  Below you will find the response that I received today. 


I apologize for the delay.  This was quite a lot of information to gather.  However, thank you for all of the great questions.  I really appreciate that you’re trying to understand NCI and its processes.  I know there is a large amount of information out there.  I will do my best to help guide you through it.


One of the best places to see the complete funding process at the level of detail you describe below is at Everything You Wanted To Know About the NCI Grants Process, beginning on page 43 of the PDF file (Chapter 2 or page 27 in the hard copy).  The topic is very technical, and this reference book provides the correct sequence of events and terminology. 


The diagram on page 53 of the PDF file above describes NCI’s grant process.  The “NCI SRG” is where patient advocates are involved.  The National Cancer Advisory Board (NCAB) performs the second level of review after the SRG.  There are always public members on NCAB.  NCAB members are presidentially appointed for 6-year terms. 


Page 64 describes the evaluation criteria used for grants by the SRG.  For more details you may be interested in the implementation of the Inclusion of Children in Research Policy.


Continuing on pages 71-72 of the PDF file, the section titled “NCI Funding Determinations” is probably of most interest to you.  Program Directors are required to follow the rank order of applications that results from the peer review process.  This process is described in more detail on page 72.


A more concise overview of how the NCI budget is developed and executed can be found at http://www.cancer.gov/aboutnci/servingpeople/BudgetProcess


Advocacy groups are involved in this process many ways, throughout each fiscal year.  Many advocacy organizations have formal liaisons to the NCAB.  The NCI Director and other NCI leadership meet with advocacy organizations to discuss issues of mutual concern.  Patient advocates have participated in at least 742 NCI activities since 2001. 


The Office of Advocacy Relations is the primary point of contact for advocacy organizations at NCI.  We work with any individual (such as yourself) or organization (such as CureSearch).  We do not maintain a public list of these organizations, however, many national organizations that provide support to cancer patients and their families have applied to be listed on our website at https://cissecure.nci.nih.gov/factsheet/FactsheetSearchResult.aspx?....    Full contact information is listed for each advocacy organization.


Executive Committee members are listed in the NCI Fact Book on page 24.  Links to all NCI Divisions, Offices, and Centers for Program Directors are found on NCI’s main website.  You can find contact information for any federal employee at NIH through the NIH Employee Directory


NCI does maintain a public database of funded grants.  Many fields are included in the database, including the grant abstract (research topic).  Grants that are not funded are confidential, and the property of the Principal Investigator who submitted the application.  The Principal Investigator may want to revise and resubmit the grant application or may want to use that idea in another application.  In fact, maintaining confidentiality of the peer review is mandated by law, and most peer review materials are shredded after the meeting. 


The NCI Fact Book discusses grants funded in rank order, versus grants funded as exceptions to this rank order, on page 11.  In FY07, 17% of grants were funded as exceptions to the established payline.  The NCI Fact Book is normally published in the spring of each year.  I recommend it as a source of information to answer a lot of your questions. 


Grant awards are not required to be published for a 30-day public comment period.


NCAB meetings are open to the public, except when they are closed to discuss proprietary issues.  Grant applications are proprietary information and confidential until they are funded.  Notice of all NCI advisory board meetings is provided to the public through the Federal Register and on publicly available websites. 


NCI’s funding policy for FY08 Research Project Grants is publicly available at http://deainfo.nci.nih.gov/grantspolicies/FinalFundLtr.htm


Here is a link to a peer-reviewed article that addresses some of the challenges and issues related to research funding and its relationship to disease statistics: http://content.nejm.org/cgi/content/full/340/24/1881.


Hope you find this helpful.  We look forward to working with you in the future.

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This one bothers me:

Case F: Should Children and Adult Subjects Both be Included in a Trial to Study a New Anti-Cancer Drug

An investigator is proposing a phase I (dose-seeking), phase II (activity determining), or phase III (definitive, randomized) clinical trial of a new agent for adults with cancer. Should the investigator include children in the proposed research project?

Possible Conditions:
Possible Consequences:

1. Applicable to all phase I, II, and III studies for adults with cancer.
May be exempt from requirement to include children because the number of children is limited and because the majority are already accessed by a nationwide pediatric cancer research network (Exclusion 4b).

The PI is encouraged to discuss his/her agent with investigators having expertise in treating children with cancer, so that development of the agent in children can occur at an appropriate time.


Explanation: The malignant conditions of childhood are often biologically different from those occurring in adults, and the response of children to anti-cancer treatments may be qualitatively and quantitatively different from the response of adults. In recognition of this, the National Cancer Institute (NCI) has established a nationwide clinical research infrastructure that focuses specifically on clinical trials to study new treatments for children with cancer (see J Clin Oncol 16:966-78, 1998). Since more anti-cancer agents can be evaluated in adults than in children (given the larger numbers of adults with cancer), an important function of these NCI-supported pediatric oncology research teams is to prioritize agents for evaluation so that agents with the greatest promise are expeditiously tested in children. Inclusion of children in adult trials would diminish accrual to pediatric studies (due to competition from adult studies), thereby delaying obtaining answers to important questions of therapy for children.

Therefore, investigators evaluating new treatments in adults with cancer need not propose inclusion of children for those cancers that NCI-supported pediatric oncology research teams already prioritize for evaluation. Instead, academic and pharmaceutical sponsors of new cancer treatments are encouraged to work with NCI staff and pediatric oncologists to assure timely and appropriate evaluations of these treatment approaches in children.

In addition to the long-established NCI network for oncology clinical trials in children, some other Institutes have or are establishing comparable networks in other fields. Investigators are encouraged to contact Institute staff to discuss this possibility.

a look up on the J Clin Oncol 16:966-78, 1998, comes up empty, if any one can find this i would like to see it.
most all the cancer research studies i have found are using exclusion 4b wich is as follows"

b. The number of children is limited because the majority are already accessed
by a nationwide pediatric disease research network, so that requiring inclusion
of children in the proposed adult study would be both difficult and unnecessary
(in that the topic was already being addressed in children by the network) as
well as potentially counterproductive (in that fewer children could be available
for the network study if other studies were required to recruit and include
them);
Looking deeper, it says this:

Survival rates for childhood cancer have risen sharply over the past 25 years. In the United States, more than 80 percent of children with cancer are alive 5 years after diagnosis, compared with about 62 percent in the mid-1970s (1). Much of this dramatic improvement is due to the development of improved therapies at children’s cancer centers, where the majority of children with cancer have their treatment.

What are children's cancer centers?
Children's cancer centers are hospitals or units in hospitals that specialize in the diagnosis and treatment of cancer in children and adolescents. Most children's, or pediatric, cancer centers treat patients up to the age of 20.

Are there standards for children's cancer centers?
The following groups have established standards for children's cancer centers or programs:

The National Cancer Institute (NCI)-sponsored Children's Oncology Group (COG), formerly two separate groups known as the Children's Cancer Group (CCG) and the Pediatric Oncology Group (POG), is a network of children's cancer centers that meet strict quality assurance standards. The COG Web site can be found at http://www.childrensoncologygroup.org/ on the Internet.

The American Academy of Pediatrics (AAP) updated its Guidelines for Pediatric Cancer Centers in 2004. This document describes the personnel and facilities needed to provide state-of-the-art care for children and adolescents with cancer. This policy statement is available at http://aappolicy.aappublications.org/cgi/content/full/pediatrics;11... on the Internet.

The American Society of Pediatric Hematology/Oncology (ASPHO) established standard requirements for programs treating children with cancer and blood disorders. The ASPHO Web site is available at http://www.aspho.org/i4a/pages/index.cfm?pageid=1 on the Internet.

These groups agree that a childhood cancer center should be staffed by a team of trained pediatric oncologists (doctors who specialize in childhood cancer) and other specialists. Other members of the health professional team usually include pediatric surgeons, specialist surgeons (e.g., neurosurgeons and urologic surgeons), radiation oncologists, pathologists, nurses, consulting pediatric specialists, psychiatrists, oncology social workers, nutritionists, and home health care professionals—all with expertise in treating children and adolescents with cancer. Together, these professionals offer comprehensive care.

Which to me is saying, they can exclude children with cancer from the adult research, becouse these three groups are doing the same thing with kids. one of those three being cure search, which they are saying is NIH funded. question is how much do these three groups get?
I was wondering the same thing this afternoon. What is the relationship between NCI, COG and CureSearch? Seems like they are all spokes of the same wheel? CureSearch is raising private funding for COG and NCI provides public funding? Do I have that right?

Peg
thats the way it appears. will take weeks to decifer all the info that gave though. I just picked a piece of it and looked for a couple answers.
What irritates me is , it looks like by giving a little to these 3 groups, they can claim exclusion 4b for everything else. Kinda leves these kids groups on their own for funding if you ask me.

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