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NIAID Launches New Approach for Investigator-Initiated Clinical Trials
When you're applying for an investigator-initiated clinical
trial, you will soon be
following a new two-stage process. First, you'll apply for
a clinical trial planning grant (R34), which lays the groundwork
for step
two, an application for
a clinical trial implementation cooperative
agreement.
The new policy will be mandatory beginning with the October 1,
2005, receipt
date (September 1 for AIDS applications) for an R34; however,
you may apply for the June receipt date if you wish. The two-step
process does not apply to applications responding to requests
for applications or requests
for proposals.
Why is NIAID making this change? We want to help you
get the necessary resources to properly plan for a trial.
This includes preparing required materials, working out costs,
and resolving
issues with
partners, sites, the Institute, and FDA, so all elements are
in place before you put your application together.
Clinical Trial Planning Grants
NIAID's new R34s fund PIs up to one
year for planning, designing,
and preparing documentation for a phase
I, II, III, or IV trial. For R34 grantees
who want to move to the next step, the
R34 becomes the basis for the subsequent application.
R34s help you build a research team, develop data management
and research oversight tools, define recruitment strategies, and
finalize items for a manual of operations, including a protocol
and investigator's brochure. Having critical elements
in place will enable NIAID and peer reviewers to
assess a trial's rationale, protocol, and design before the Institute
commits a
large amount
of funds. Here are the salient features of the R34:
- Up to $75,000 in direct costs for planning and design of a phase
I clinical trial.
- Up to $150,000 in direct costs for a phase II, III, or IV
trial.
- One year of support to plan a trial.
- Standard PHS 398 grant application.
- NIAID approval before submitting.
- Peer review by NIAID scientific
review groups.
- No support for collecting preliminary data or pilot studies.
Clinical Trial Implementation Cooperative Agreement
Only R34 awardees can apply for a Clinical Trials Implementation
Cooperative Agreement (U01), though getting an R34 does not guarantee
funding for an implementation award. We'll receive the first U01
applications on June 1, 2006,
(May 1 for
AIDS) and within four months will complete our peer review and
make an award, if funded. Main features of the U01 are:
- Up to five years of support.
- PHS 398 grant application with additional instructions.
- Protocol, investigator's brochure, and manual of operations
included in the application.
- Peer review by NIAID scientific review groups.
- Award about four months after application receipt.
For more information, read the Guide notices coming in the next few days.
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Why Does NIAID Reset Grant Start Dates?
Since FY 2001, NIAID has reset start dates for competing grants
to help correct an imbalance in the number of grants awarded
in the third and fourth quarters of the fiscal
year.
This move ensures that we have the staff to handle
the grant workload by avoiding an end-of-fiscal-year crunch.
It also lets us address Congress's concerns about grant numbers,
costs, and outlay rates.
Our policy affects all grants -- AIDS, biodefense, and nonbiodefense
-- except three-year R01s and other short-term awards. For
details on
this year's
approach,
see Grants
to Get Shorter First Years, New Anniversaries.
Because we award only 20 to 25 percent of our grants
each fiscal year, it takes four to five years to redistribute
our portfolio. NIAID had been making headway in shifting
awards to earlier timeframes until FY 2003.
That year,
the research community quickly responded to the national
call for biodefense applications, prompting NIAID to fund 70
percent
of its biodefense awards in the fourth quarter. This influx
of new funding negated our earlier progress redistributing
grants, forcing us to reset start dates again to avert another
end-of-fiscal-year
squeeze.
It will likely take a few more years to fully rebalance our
portfolio. We'll keep you posted on our progress and whether
we will need to reset grant start dates again. |
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AIDS and Nonbiodefense Funding Are Comparable
Last month Science published an open letter positing
that the large influx of biodefense money in FY 2002
and 2003 into NIH, and particularly NIAID, diverted resources
from
traditional research areas. NIAID responded to those concerns
-- see the Open
Letter in Science Regarding NIH Biodefense Funding on
the Web and the NIH
Response to Open Letter in
the April 1 issue of Science.
Since then, we've received requests for a comparison of funding
growth for NIAID AIDS and NIH nonbiodefense research. As you
can see in the table below, funding increases in both areas were
comparable.
Growth in Research for NIAID AIDS and NIH Nonbiodefense FY 2000 to FY 2005
(dollars in millions)
| Type of Research |
FY 2000 |
FY 2005 |
Increase |
| NIAID AIDS |
$ 916 |
$ 1,460 |
59% |
| NIH nonbiodefense |
17,771 |
26,728 |
50% |
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Post-Trial Access to Antiretrovirals Gets a Thumbs Up
Are you conducting HIV antiretroviral treatment trials in a developing country? If so, NIH wants you
to work with the host country to identify sources of antiretrovirals
for participants seeking to continue treatment
after their participation in the clinical trial ends.
Investigators and contractors should discuss
sources of antiretroviral treatment with host country authorities
and other stakeholders such as governments, non-governmental
organizations, pharmaceutical manufacturers,
advocacy groups, and research organizations.
If your application's priority score is in the fundable
range, you will be expected to give your program officer plans
to identify sources
of antiretrovirals for your research
participants. Availability of post-trial treatment
may affect whether you are selected as a clinical trial site.
See the March
16, 2005, Guide notice for more information.
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NIH Tweaks 398
NIH announced small changes to the PHS
398 instructions, revising Part II
Human Subjects Research Supplement, expanding the list of acceptable
fonts, and tweaking other items. For details, see the March
16, 2005, Guide notice, and check NIH
Forms and Applications for further updates.
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Opportunities and Resources
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Four Million Specimens and Related Data Ready for Study
Calling on investigators from basic scientists to epidemiologists: we've got resources for you. Approximately four million biological specimens and related
information await your scrutiny.
This plentitude stems from three long-running cohort studies supported by NIH: Multicenter AIDS Cohort Study (MACS), Women's Interagency HIV Study (WIHS), and Women and Infants Transmission Study (WITS). Many participants have been followed for 20 years or longer.
We're very interested in receiving grant applications from investigators in different disciplines who will use these data and specimens to expand knowledge of the natural history, pathogenesis, virology, immunology, and epidemiology of HIV and AIDS.
Investigators will need letters of collaboration before
submitting an application. Each study has a defined procedure for
submission and review of new proposals from internal or external
investigators who want to analyze data or specimens.
Go to these Web sites for information on accessing data and specimens:
Find more information on the studies in Details on MACS, WIHS, and WITS for Applicants Proposing to Use Study Resources. |
Advice Corner
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Reader Question on Finding Progress Report Information Online
Photini Sinnis, M.D., assistant professor, Department of Parasitology, New York University School of Medicine, wrote:
"Now that NIH has gone (almost) completely electronic, I am having a hard time figuring out the ins and outs of submitting annual progress reports as well as final progress reports. I no longer receive the packet in the mail that has all the forms I need to fill out as well as the deadline. Where is this information now, and what are the deadlines?"
You can find the information you need on our site. Start reading at Send Us an Annual Progress Report in the NIH Grant Cycle: Application to Renewal.
You can search for your due date at Progress Report Search by IPF Number. |
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Reader Question on Resetting Grant Start Dates in Other Institutes
Arnold Bayer, M.D., professor of medicine, UCLA School of Medicine and associate chief, Division of Adult Infectious Diseases, Harbor-UCLA Medical Center, wrote:
"Is shortening the grant year NIH-wide or only for NIAID? For example, if I have a grant funded by NHLBI, does my grant come under this rule?"
No. Resetting grant start dates, which we wrote about in this issue and in our March 4 article, "Grants to Get Shorter First Years, New Anniversaries," is an NIAID policy. To find out how other institutes are managing their grants, contact your grants specialist there. |
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