Mr. Early: Will the NIA be able to fund noncompeting grants at the commitment level under the FY 92 request? New and competing grants at the peer reviewed levels?

Dr. Williams:

Under the FY 1992 request, the NIA will be able to fund noncompeting grants slightly below the commitment level. We project we will be able to fund new and competing grants on the average of 15.6% below the peer reviewed level.

RESEARCH PROJECT GRANTS

Mr. Early: What percentage of new and competing grants will the institute fund under the FY 92 budget request, and how does this compare to FY 91 and FY 90?

Dr. Williams: Our estimated award rate for FY 1992 is 22.8% and 39.4% for FY 1991. The award rate for the NIA in FY 1990 was 24.08.

Mr. Early: How does this compare to the award rate of five years ago? Ten years ago?

Dr. Williams: Our award rate for 1986 (five years ago) was 31.1% and 23.6% in 1981 (ten years ago).

Mr. Early: What is the projected "success rate" and how does this compare to FY 91 and FY 90?

Dr. Williams: Our projected success rate for FY 1992 is 22.1%; for FY 1991, our estimated success rate is 37.0%. In FY 1990, the success rate for the NIA was 21.6%.

Mr. Early: Five years ago? Ten years ago?

Dr. Williams: Our success rate five years ago was 25.0% and ten years ago it was 15.4%.

Mr. Early: How would you characterize the quality of research applications the institute is receiving today? What kinds of comparisons would you make to prior years?

Dr. Williams: With the continually growing interest in and resources available for aging-related research, and our encouragement of many of the best scientists in relevant fields, we see steadily increasing numbers of applications of very high quality.

Mr. Early: To what payline percentile will the institute be able to fund under the budget request and how does this compare to FY 91 and FY 90?

Dr. Williams: The budget request would permit funding to the 22nd percentile. The estimated payline for FY 1991 is 34; in FY 1990 the payline was 24.2.

CLINICAL TRIALS

Mr. Early: Will you be able to continue the clinical trials now underway at the planned levels with the FY 92 budget request? Are there any that will have to be curtailed or stretched out?

Dr. Williams: Ongoing trials and trials we plan to begin in FY 1991 will continue at the same level of effort under the FY 1992 budget levels. No ongoing trials will be curtailed.

Mr. Early: Are there any clinical trials that could be undertaken in FY 92 if additional resources were available:

Dr. Williams: Yes. If additional resources were available, clinical trials could begin on geriatric rehabilitation, malnutrition in geriatrics, growth hormone factors, pharmacological agents for Alzheimer's disease, muscle loss and

cardiac function.

Mr. Early: Please provide for the record a list of approved but unfunded clinical trials, along with a brief description of the trial, its duration, the first year cost and the estimated total cost of the trial.

Dr. Williams: The following major new clinical trials would be ready for initiation in 1991 if funds were available:

STOP-IT (Sites Testing Osteoporosis Prevention/Intervention
Treatments) -- Expansion

Description: A set of clinical trials to test promising ways to maintain or increase bone strength in persons over 65. Companion studies on the causes of progressive bone loss in late life will be included.

Treatment of Cognitive Impairments/Behavior Disorders Associated with Alzheimer's Disease -- Expansion

First Year Cost: $1,500,000
Estimated Total Cost: $8,120,000

Duration: 5 years

Description: Testing of additional compounds aimed at

slowing, halting, or if possible reversing, the progressive decline in cognitive function in Alzheimer's victims.

Prevention of Hypertension in Elderly

First Year Cost: $1,600,000

Estimated Total Cost: $8,660,000
Duration: 5 years

Description: This study will test the efficacy of weight loss
and sodium restriction following withdrawal of

antihypertensive medications. The significance of the
proposed study is that findings may identify a safe and
well-tolerated method by which to discontinue
antihypertensive drug therapy in elderly persons who are
currently being treated with blood pressure medications.

The following major new clinical trials would be ready for initiation in 1992 if funds were available:

Description: There is a need for rigorous studies of hip
fracture rehabilitation strategies to decrease current
high rates of long term disability. Rehabilitation
techniques for both cognitive and motor deficits following
stroke need development and testing in older patients to
improve their outcomes. There is also a need for trials
of improved assessment techniques to detect moderate
levels of disabilities which could be alleviated by
rehabilitation.

Interventions Against Malnutrition in Geriatrics
First Year Cost: $2,000,000

Estimated Total Cost: $6,240,000
Duration: 3 years

Description: There is evidence that the number of
severely malnourished nursing home or homebound patients
far exceeds the malnourished hospital populations, but
data are lacking on the effectiveness of nutrient
supplementation or other strategies for these patients.
Many of these issues could be resolved by relatively
small-scale short term studies using available
interventions.

Systemic Effects of Chronic Treatment of Elderly with Growth Hormone Stimulating Factors

First Year Cost: $275,000

Estimated Total Cost: $1,050,000
Duration: 4 years

Description: Preliminary studies suggest that hormone
supplementation or exercise may partially reverse changes
seen with aging in muscle mass and strength, skin
thickness, and bone density. Some older persons tend to
be both hormone deficient and sedentary. This trial will
evaluate the effects of graded exercise and replacement of
growth hormone and sex appropriate steroids in moderately
physically impaired older men and women.

Description: Intramural clinical trials to (a) evaluate treatment efficacy of thyrotropin-releasing hormone; (b) evaluate motor and cognitive abilities after

administration of haloperidol; and (c) measure performance with a PET scan on a graded intensity test before and after cholinergic drug administration.

Effects of Strength Training on Age-Associated Muscle Loss
First Year Cost: $400,000

Estimated Total Cost: $600,000

Duration: 2 years

Description: Significant differences exist between women
and men in muscle strength and body mass which become
greater with increasing age and may, in part, account for
the greater degree of frailty in elderly women. A program
of strength training in elderly women and men would be
conducted to identify the specific neural and endocrine
(hormone) controls of muscle function and their effects on
changes in muscle mass in adaptation to exercise.

Effect of Pacemaker Rate on Cardiac Function

First Year Cost: $175,000

Estimated Total Cost: $600,000

Duration: 3 years

Description: There is suggestive preliminary data that there
may be clinically significant changes in the circulation
of patients fitted with pacemakers because of
inappropriate setting of the pacemaker rate which may
eliminate nocturnal decline of heart rate. This trial
would evaluate the effect of pacing rate on cardiac
function in patients with demand atrial pacemakers.

Mr. Early:

Doctor, what impact will the financial management plan have on your institute's ability to mount and fund clinical trials?

Dr. Williams: Implementation of our financial management plan does help ensure optimal use of all of our resources, including those for clinical trials.

RESEARCH CENTERS

Mr. Early: The budget request proposes an increase +2.5% for the centers program. What is the average increase in a center grant under the budget request?

2.5%.

Dr. Williams: The average center award will increase by

Mr. Early: How was the size of this increase determined?

Dr. Williams: In order to maximize funding for research project grants, a 2.5% increase was deemed appropriate for NIA's centers mechanism.

Mr. Early: What was the level of downward negotiations in the centers program in FY 89 and FY 90? And what is the estimate for FY 91?

Dr. Williams: In FY 1989 there was no downward negotiation in the centers program. In FY 1990, the level of downward negotiation was 15.2%. There will be no arbitrary downward negotiations for centers in FY 1991. The NIA will carefully examine each center grant and implement cost management measures on an individual basis.

Mr. Early: Doctor, will the NIA be able to fund noncompeting centers at commitment levels under the budget request? Competing centers at the peer reviewed levels?

Dr. Williams: Under the President's budget for FY 1992, the NIA will fund noncompeting centers slightly below commitment levels. The NIA will fund only one competing center under the current budget request; this center will be funded at less than peer reviewed level.

FINANCIAL MANAGEMENT PLAN

Mr. Early: Doctor, how does your Institute plan to administer the financial management plan with respect to research project grants? How do you plan to stay within the parameters that have been set? Research centers grants?

Dr. Williams: In 1991 beginning with the first council round, the NIA instituted cost-containment policies that eliminate the arbitrary downward reductions which were instituted in past years. Each potential competing grant is now carefully examined to determine what level of budgetary adjustments can be effected without damaging the science of the proposed project. NIA has instructed its study sections to pay special attention to proposed budgets in light of the cost-containment issue. It must be emphasized that each grant proposal is then considered individually by NIA staff, and that budgetary adjustments are made on a case-by-case-basis. Regarding non-competing awards, NIA staff ensure that future year costs budgeted for each award reflect an accepted inflationary increase of 4% from the first year adjusted cost, taking into consideration any study section recommendations concerning scientific needs for the future years of the project. Regarding the average length of award, NIA will continue to examine its grant portfolio and work to maintain our present average length of 3.9 years.

NIA study sections and staff apply the same level of scrutiny to the budgets in the centers applications as is given to the research project grant applications.

Mr. Early: Does the NIA plan to make greater use of "out of order" funding to achieve a lower cost per award?

Dr. Williams: Because of our desire to fund quality research as efficiently as possible, we have been and will continue to be watchful of quality projects that await funding. We use percentile criteria as a guide, rather than as an arbitrary cutoff for decisions on grant funding. Whether or not we make greater use of out of order funding will depend upon the quality of particular grant applications and Institute judgement of scientific need, balanced against available resources.

Mr. Early: What has been the reaction of your study sections to the financial management plan, and limiting the overall average increase in the cost of a grant?

Dr. Williams: Our study sections understand and appreciate the purpose of the plan, and take their charge seriously when