ACUPUNCTURE CLINICAL TRIAL PILOT GRANTS

Release Date:  February 25, 1998

PA NUMBER:  PAS-98-033

P.T.

Office of Alternative Medicine
National Cancer Institute
National Heart, Lung and Blood Institute
National Institute of Dental Research
National Institute of Arthritis and Musculoskeletal and Skin Disorders
National Institute of Neurological Disorders and Stroke
National Institute on Drug Abuse
Agency for Health Care Policy and Research

Letter of Intent Receipt Date:  April 10, 1998
Application Receipt Date:  May 13, 1998

PURPOSE

The National Institutes of Health (NIH) is committed to investigating the
efficacy of acupuncture for treating or preventing disease and accompanying
symptoms by supporting well-designed, well-executed, randomized clinical trials
(RCT).  Before proceeding to a full-scale RCT, pilot clinical studies are often
required.  In the present program announcement (PA), the NIH announces its
interest in supporting pilot studies to establish the methodological feasibility
and strengthen the scientific rationale for proceeding to full-scale RCTs on the
use of  acupuncture to prevent, manage, or treat various symptoms/disorders.  The
emphasis of these pilot trials should be placed on the development of appropriate
study design rather than on attempts to complete an insufficiently powered RCT. 
For the purposes of this PA, trials of acupuncture incorporating moxibustion or
herbal medicine will not be considered.  Under this PA, applications will be
accepted on a single application receipt date and reviewed by a Special Emphasis
Panel (SEP) administered through the Center for Scientific Review (CSR).

HEALTHY PEOPLE 2000

The Public Health Service is committed to achieving the health promotion and
disease prevention objectives of "Healthy People 2000," an initiative for setting
national health policy and priorities.  Although "Healthy People 2000" does not
have an acupuncture objective, this PA involves priority areas within the
"Healthy People 2000" objectives, such as the area of chronic disabling
conditions.  Potential applicants may obtain a copy of "Healthy People 2000"
(Full Report: Stock No. 017-001-00474-0 or Summary Report:  Stock No.
017-001-00473-1) through the Superintendent of Documents, Government Printing
Office, Washington, DC 20402-9325 (telephone 202-512-1800).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by foreign and domestic, for-profit and non-profit
organizations, public and private, such as universities, colleges, hospitals,
laboratories, units of State and local governments, and eligible agencies of the
Federal government.  Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as principal investigators.

MECHANISM OF SUPPORT

The mechanism of support for this PA is the research project grant (R01).  Since
the proposed research is pilot in nature, grants may not exceed $350,000 per year
in total costs (direct and indirect) nor extend beyond three years.  This PA is
a one-time solicitation with a single receipt date.  Future unsolicited competing
continuation applications will compete with all investigator-initiated
applications and be reviewed according to the customary peer review procedures.

FUNDS AVAILABLE

Up to $700,000 in total costs (direct plus indirect) in the first year will be
available from the Office of Alternative Medicine (OAM) to fund 2-3 awards from
meritorious, qualified applicants.  In addition, the National Cancer Institute
(NCI), the National Heart, Lung and Blood Institute (NHLBI), the National
Institute of Dental Research (NIDR), the National Institute of Arthritis and
Musculoskeletal and Skin Disorders (NIAMS), the National Institute of
Neurological Disorders and Stroke (NINDS), the National Institute on Drug Abuse
(NIDA), and the Agency for Health Care Policy and Research (AHCPR) will support
other meritorious applications that fit their program objectives.  Funding levels
are dependent on the receipt of applications of high technical and scientific
merit, and the continued availability of funds.  Because the nature and scope of
applications may vary, it is anticipated that the award size will vary.  Although
this program is provided for in the financial plans of the OAM, awards pursuant
to this PA are contingent upon availability of funds for this purpose.  Funding
beyond the first and subsequent years of the grant will be contingent upon
satisfactory progress during the preceding years and availability of funds.

RESEARCH OBJECTIVES

The objective of "Acupuncture Clinical Trial Pilot Grants" is to increase the
quality of clinical research evaluating the efficacy of acupuncture for the
treatment or prevention of disease and accompanying symptoms.  To meet this
objective, the proposed pilot study must successfully incorporate creative and
realistic solutions to difficult problems in clinical research for the particular
disease/condition under study.

The application should directly address how the pilot grant will advance the
design of a subsequent full-scale RCT.  In preparing for the definitive RCT,
these pilot studies should address questions that are formulated to optimize the
design of the eventual RCT rather than address the clinical question with lower
power.  The application should also address the intrinsic scientific merit of the
study conducted under the pilot grant, regardless of whether a full-scale trial
is eventually performed.  For the purposes of this PA, trials of acupuncture
incorporating moxibustion or herbal medicine will not be considered.

Applications in response to "Acupuncture Clinical Trial Pilot Grants" may
include, but are not limited to:

1.  Studies to refine the intervention strategy including:  duration and
frequency of treatment; type of treatment (needling versus electroacupuncuture
versus laser acupuncture); evaluations of different systems of acupuncture
(Chinese, Japanese, French, etc.).

2.  Studies to refine the control strategy including comparisons of different
types of controls (e.g., invasive control [sham] versus non-invasive control
[placebo, standard therapy, wait list, etc.]).

3.  Studies to define and refine the target population (e.g., inclusion/exclusion
criteria) and develop adequate recruitment procedures.

4.  Collection of preliminary data for establishing measures of efficacy and
safety.

5.  Studies to determine the feasibility of the treatment strategy and develop
realistic protocols.

6.  Studies to establish the anticipated benefit of the treatment and to
ascertain even rates (success and complications).

7.  Studies leading to large scale patient outcomes trials and cost-effectiveness
analysis,  may include, but are not limited to, the following areas: methods,
health-related quality of life measures, common health conditions treated, types
of providers, types of individuals seeking acupuncture, treatment and duration,
and treatment setting.  Inquiries concerning these topics should be addressed to
the appropriate contact at AHCPR (see INQUIRIES).

Possible diseases/conditions of interest include, but are not limited to:

o  Acute pain associated with surgery, dental procedures, low back pain, cancer
breakthrough pain, and vaso-occlusive crises in sickle cell disease;

o  Angina Pectoris and cardiac arrhythmias;

o  Asthma as an adjuvant to standard care, and dyspnea;

o  Carpal tunnel syndrome;

o  Chronic pain associated with back pain, cancer, fibromyalgia,
temporomandibular disorders, HIV/AIDS, or Reflex Sympathetic Dystrophy;

o  Hypertension and vascular disease;

o  Stroke;

o  Nausea and vomiting associated with chemotherapy or pregnancy;

o  Drug abuse and addiction;

Applicants are strongly encouraged to contact the designated staff (see
Inquiries) at participating NIH institutes and AHCPR to discuss other possible
research areas.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and their
subpopulations must be included in all NIH supported biomedical and behavioral
research projects involving human subjects, unless a clear and compelling
rationale and justification is provided that inclusion is inappropriate with
respect to the health of the subjects or the purpose of the research.  This
policy results from the NIH Revitalization Act of 1993 (Section 492B of Public
Law 103-43).

All investigators proposing research involving human subjects should read the
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical
Research," which have been published in the Federal Register of March 28, 1994
(FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No.
11, March 28, 1994.

LETTER OF INTENT

Applicants are asked to submit, by April 10, 1998 a letter of intent that
includes the number and title of this PA; the name, address, and telephone number
of the Principal Investigator (s); the identities of other key personnel and
participating organizations or institutions, if any; and a title describing the
proposed research.

Although a letter of intent is not required, is not binding, and does not enter
into the review of applications, the information that it contains will be
especially helpful in planning for the review of applications, estimating the
potential work-load, and avoiding conflicts of interest in the review process.

Mail/Fax letters of intent to:

Dr. Richard L. Nahin
Office of Alternative Medicine
National Institutes of Health
Building 31, Room 5B36
Bethesda, MD  20892-2182
Telephone:  (301) 435-5042
FAX:  (301) 402-4741
Email:  NahinR@OD31EM1.OD.NIH.GOV

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev.
5/95) with a one time receipt date.  Application kits are available at most
institutional offices of sponsored research and may be obtained from the Division
of Extramural Outreach and Information Resources, National Institutes of Health,
6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267,
email: ASKNIH@od.nih.gov.

The title and number of the program announcement must be typed in Section 2 on
the face page of the application.  As with most applications to NIH, the research
plan is limited to 25 pages.

The completed original application and four legible copies must be sent or
delivered to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892
BETHESDA, MD  20817 (for express/courier service)

In order to facilitate the review of applications, the applicant must at the same
time, mail or deliver one copy of the application to:

Richard L. Nahin, M.P.H., Ph.D.
Office of Alternative Medicine
National Institutes of Health
Building 31, Room 5B36
Bethesda, MD  20892-2182
Telephone:  (301) 435-5042
FAX:  (301) 402-4741

REVIEW CONSIDERATIONS

General Considerations

Upon receipt, applications will be reviewed for completeness by the CSR. 
Incomplete applications will be returned to the applicant without further
consideration.  Applications that are complete will be evaluated for scientific
and technical merit by an appropriate SEP convened by the CSR in accordance with
the NIH peer review procedures.  As part of the initial merit review, all
applications will receive a written critique and undergo a process in which only
those applications deemed to have the highest scientific merit, generally the top
half of applications under review, will be discussed, assigned a priority score,
and receive a second level review by the appropriate National Advisory Council.

Review Criteria

All applications submitted in response to this PA will be reviewed according to
the following review criteria.  Reviewers will consider these criteria when
assigning a single overall score to each application.  This single score should
reflect their judgment that the proposed research will have a substantial impact
on the pursuit of its goals.

(1)  Significance:  Does this study address an important problem?  If the aims
of the application are achieved, how will scientific knowledge be advanced?  What
will be the effect of these studies on the concepts or methods that drive this
field?  In addition, the following must be addressed:
- The scientific basis for the proposed intervention including discussion of
current practice and alternative interventions;
- Impact of the proposed intervention on health care and quality of life.

(2)  Approach:  Are the conceptual framework, design, methods, and analyses
adequately developed, well integrated, and appropriate to the aims of the
project?  Does the applicant acknowledge potential problem areas and consider
alternative tactics?  In addition, the following should be addressed:
(a) Study Design and Procedures
- Sequence of clinical studies, including the proposed pilot study, that will
produce a definitive clinical trial;
- Translation of the clinical question into statistical hypotheses;
- Selection of outcome measure(s);
- Inclusion and exclusion criteria;
- Secondary questions (including capacity for post hoc analyses);
- Detailed protocol with standardized procedures that will be used for this pilot
study;
- Ethical and safety issues, and quality control procedures;
- Necessity for randomization and masking;

(b) Data Analysis
- Specific methods to be used for data analysis;
- The sample size for the pilot study may not be adequate to detect any but the
largest treatment differences; however, the data from this study should provide
a basis for providing sample size estimates for future trials;
- Population and demographics of the clinical condition;

(3) Innovation:  Does the project employ novel concepts, approaches or method?
Are the aims original and innovative?  Does the project challenge existing
paradigms or develop new methodologies or technologies?

(4)  Investigator:  Is the investigator appropriately trained and well suited to
carry out this work?  Is the work proposed appropriate to the experience level
of the principal investigator and other researchers (if any)?  In addition, the
following should be addressed:
- Training and expertise in the clinical problem and in acupuncture;
- Training and expertise in clinical trials;

(5)  Environment:  Does the scientific environment in which the work will be done
contribute to the probability of success?  Do the proposed experiments take
advantage of unique features of the scientific environment or employ useful
collaborative arrangements?  Is there evidence of institutional support?

Each project will be reviewed for the adequacy of plans to include genders,
minorities, and their subgroups as appropriate for the scientific goals of the
research.  Plans for the recruitment and retention of subjects also will be
evaluated.

The adequacy of the proposed protection for humans, animals or the environment
will be evaluated to the extent they may be adversely affected by the project
proposed in the application.

AWARD CRITERIA

The following will be considered in making funding decisions:  Quality of the
proposed project as determined by peer review, availability of funds, and program
priority.

INQUIRIES

Applicants are strongly encouraged to contact the individuals designated below,
in advance of preparing an application, for additional information concerning the
areas of research and other types of pre-applications consultation.

Dr. Patricia S. Bryant
Division of Extramural Research
National Institute of Dental Research
Natcher Building, Room 4AN-24E
Bethesda, MD 20892-6500
Telephone:  (301) 594-2095
FAX:  (301) 480-8318
Email:  BryantP@de45.nidr.nih.gov

Dr. Mary A. Cummings
Center for Outcomes and Effectiveness Research
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 605
Rockville, MD  20852
Telephone:  (301) 594-1485
FAX:  (301) 594-3211
Email:  mcumming@ahcpr.gov

Debra Grossman
Division of Clinical and Services Research
National Institute on Drug Abuse
Parklawn Building, Room 10A-10
Bethesda, MD  20892-8025
Telephone:  (301) 443-0107
FAX:  (301) 443-8674
Email:  dg79a@nih.gov

Dr. Cheryl A. Kitt
Division of Convulsive, Infectious and Immune Disorders
National Institute of Neurological Disorders and Stroke
7550 Wisconsin Avenue, Room 504
Bethesda, MD  20892
Telephone:  (301) 496-1431
FAX:  (301) 402-2060
Email:  KittC@ninds.nih.gov

Dr. Michael C. Lin
Division of Heart and Vascular Diseases
National Heart, Lung and Blood Institute
6701 Rockledge Drive, Suite 10193
Bethesda, MD  20892-7956
Telephone:  (301) 435-0560
FAX:  (301) 480-2948
Email:  ml50z@NIH.GOV

Dr. Richard L. Nahin
Office of Alternative Medicine
National Institutes of Health
Building 31, Room 5B36
Bethesda, MD  20892-2182
Telephone:  (301) 435-5042
FAX:  (301) 402-4741
Email: NahinR@OD31EM1.OD.NIH.GOV

Dr. James Panagis
Orthopaedics Program
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Natcher Building,  Room 5AS-37K - MSC 6500
Bethesda, MD  20892-6500
Telephone:  (301) 594-5055
FAX:  (301) 480-4543
Email:  panagisj@ep.niams.nih.gov

Dr. Claudette Varricchio
Division of Cancer Prevention
National Cancer Institute
6130 Executive Boulevard, Room 300
Rockville, MD  20852-7340
Telephone:  (301) 496-8541
FAX:  (301) 496-8667
email:  VarriccC@dcpcepn.nci.nih.gov

Direct inquiries regarding fiscal matters to:

Vicki Maurer
Grants Management Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
45 Center Drive, Room 5AS-37H
Bethesda, MD  20892-7510
Telephone:  (301) 594-3504
FAX:  (301) 480-5450
Email:  maurerv@ep.niams.nih.gov

Martin R. Rubinstein
Grants Management Office
National Institute of Dental Research
45 Center Drive, Room 4AN-44A
Bethesda, MD  20892-6420
Telephone:  (301) 594-4800
FAX:  (301) 480-8301
Email:  Rubinstein@de45.nidr.nih.gov

Karen D. Shields
Grants Management Branch
National Institute of Neurological Disorders and Stroke
Federal Building, Room 1004
Bethesda, MD  20892
Telephone:  (301) 496-9231
FAX:  (301) 402-0219
Email:  ks26n@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance Nos.
93.121, 93.180, 93.213, 93.226, 93.279, 93.396, 93.837, 93.838, 93.846, and
93.853.  Awards are made under authorization of the Public Health Service Act,
Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241
and 285) and administered under PHS grants policies and Federal Regulations 42
CFR 52 and 45 CFR Part 74.  This program is not subject to the intergovernmental
review requirements of Executive Order 12372 or Health Systems Agency review.

The PHS strongly encourages all grant and contract recipients to provide a smoke-
free workplace and promote the non-use of all tobacco products.  In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain
facilities (or in some cases, any portion of a facility) in which regular or
routine education, library, day care, health care or early childhood development
services are provided to children.  This is consistent with the PHS mission to
protect and advance the physical and mental health of the American people.

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