[Federal Register Volume 64, Number 108 (Monday, June 7, 1999)]
[Notices]
[Pages 30341-30342]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-14245]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Diabetes and Digestive and Kidney Diseases: 
Opportunity for Cooperative Research and Development Agreements 
(CRADAs) in Conjunction With a Major Multicenter Clinical Trial--the 
Study of Health Outcomes of Weight Loss (SHOW)

AGENCY: National Institutes of Health, Public Health Service, DHHS.

ACTION: Notice.

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SUMMARY: The National Institute of Diabetes and Digestive and Kidney 
Diseases (NIDDK) seeks capability statements from parties interested in 
entering into a potential Cooperative Research and Development 
Agreement (CRADA) to provide anti-obesity agents for treating subjects 
in the Study of Health Outcomes of Weight Loss (SHOW).
    Collaborator applicants developing capability statements may also 
include proposals to provide funding for assessment of outcomes of 
interest to the Collaborator. The availability of provide sector 
support may increase the feasibility of particular aspects of the final 
SHOW design, but the primary criterion for selecting potential 
collaborator(s) is the scientific merit of proposals for use of anti-
obesity agents.
    The control of the SHOW clinical trial shall reside entirely with 
the Institute and the scientific participants of the trial. In the 
event that any adverse effects are encountered which, for legal or 
ethical reasons, may require communications with the FDA, the relevant 
collaborating institutions will be notified. Neither the conduct of the 
trial nor the results should be represented as an NIDDK endorsement of 
the drug under study.

DATES: Only written CRADA capability statements received by the NIDDK 
on or before September 1, 1999 will be considered during the initial 
design phase, confidential information must be clearly labeled. 
Potential collaborators may be invited to meet with the Selection 
Committee at the Collaborator's expense to provide additional 
information. The Institute may issue an additional notice of CRADA 
opportunity during the design of the trial if circumstances change or 
if the trial design alters substantially.

FOR FURTHER INFORMATION AND QUESTIONS: Capability statements should be 
submitted to Dr. Michael W. Edwards, Office of Technology Development, 
National Institute of Diabetes and Digestive and Kidney Diseases, 
National Institutes of Health, BSA Building, Suite 350 MSC 2690, 9190 
Rockville Pike, Bethesda, MD 20814-3800; Tel: 301/496-7778, Fax: 301/
402-0535; Email: [email protected].

SUPPLEMENTARY INFORMATION: SHOW will be conducted as a cooperative 
agreement among the SHOW Clinical Centers (approximately fifteen 
centers), a Data Coordinating Center, and the NIH. SHOW will address 
two primary research questions: (1) Do interventions designed to 
produce sustained weight loss in obese individuals with type 2 diabetes 
improve health? (2) How do the benefits and risks of interventions 
designed to produce weight loss compare with the benefits and risks 
related to treatment of obesity-related comorbid conditions in the 
absence of weight loss intervention?
    SHOW is expected to recruit approximately 6000 obese diabetic 
patients over a three-year period with four additional years of 
treatment and follow-up (average treatment duration 5.5 years). It is 
anticipated that two-thirds of the patients recruited to the study will 
be randomly assigned to enrollment in weight loss interventions and 
one-third to community care. The SHOW trial is likely to have three 
arms, as follows:
    (1) Community Care--Patients will receive medical care for their 
obesity and obesity-related comorbid conditions (e.g., diabetes, 
hypertension, dyslipidemia) from their primary care physician. The 
primary care physician will be given standard of care recommendations 
for treatment of obesity and comorbid conditions (e.g., guidelines from 
the American Diabetes Association) and will be provided with results of 
diagnostic tests carried out at study sites.
    (2) Intensive Lifestyle Intevention--Patients will under go a long-
term behavioral treatment program that includes dietary modification, 
increased physical activity, and behavioral therapies designed to 
enhance weight loss and weight maintenance. This intervention is 
anticipated to be conducted in groups. Obesity-related comorbid 
conditions will be treated by the primary care physician as in Group 1.
    (3) Intensive Lifestyle Intervention plus Weight-Loss Medication--
Medication will be added to the intensive lifestyle intervention in an 
attempt to enhance long-term weight maintenance. Comorbid conditions 
will be treated by the primary care physician as in Group 1.
    The SHOW RFAs may be accessed at:

http://www.nih.gov/grants/guide/rfa-files/RFA-DK-98-019.html for 
Clinical Centers RFA
http://www.nih.gov/grants/guide/rfa-files/RFA-DK-98-020.html for the 
Data Coordinating Center RFA

Capability Statements

    The design concept described above is not final. The final design 
will be developed over the course of the first year of the trial by the 
SHOW Steering Committee (which will include the Principal Investigators 
of the Clinical Centers, the Principal Investigator of the Data 
Coordinating Center, and the NIDDK Project Coordinator). It is possible 
that the final design for SHOW may include no anti-obesity agents, or 
may include more than one anti-obesity agent.
    A Selection Committee will utilize the information provided in the 
``Collaborator Capability Statements'' received in response to this 
announcement to help in its deliberations. The Selection Committee will 
interact with the Steering Committee to develop the most appropriate 
design, based on a thorough understanding of the efficacy and side 
effects associated with all agents proposed.
    It is the intention of the NIDDK that all qualified collaborators 
have the

[[Page 30342]]

opportunity to provide information to the Selection Committee through 
their capability statements. The Capability Statement should not exceed 
10 pages and should address the following selection criteria:
    (1) The statement should provide specific details regarding the 
safety and efficacy of the proposed anti-obesity agency for long-term 
use in obese diabetic patients with a description how it might be 
utilized in SHOW.
    (2) The statement should include a detailed plan demonstrating the 
ability of the Collaborator to provide sufficient quantities of the 
agent in a timely manner for the duration of the study.
    (3) The statement should outline outcome measures proposed by the 
Collaborator which support the aims of SHOW. The specifies of the 
proposed outcome measures and the proposed support could include, but 
not be limited to the following: Specific funding commitment to support 
the advancement of scientific research, personnel, services, 
facilities, equipment, or other resources that would contribute to the 
conduct of the trail.
    (4) The statement must address willingness to promptly publish 
research results and ability to be bound by PHS intellectual property 
policies (see CRADA: http://www.nih.gov/od/ott/crada198.htm).

    Dated: May 26, 1999.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 99-14245 Filed 6-4-99; 8:45 am]
BILLING CODE 4140-01-M