NIH GUIDE, Volume 26, Number 19, June 6, 1997




P.T. 34



  Clinical Trial 

  Data Management/Analysis+ 


National Institute of Mental Health


The Psychotherapeutic Medication Development Program of the National

Institute of Mental Health (NIMH) is committed to developing "orphan"

treatments (treatments having a potentially large public health

impact but lacking corporate sponsorship) for mental disorders.  For

about 15 years, Europeans have used an herbal treatment for

depression, Hypericum perforatum/Saint Johnswort (hypericum).

Hypericum has become increasingly popular in Germany where physicians

routinely prescribe herbal medicines.  In 1994, 66 million daily

doses of hypericum were prescribed there for use in the treatment of

depression.  Working with the NIH Office of Alternative and

Complementary Medicine (OAM), NIMH intends to conduct a efficacy

study of a standardized extract of hypericum in major depression.

The purpose of this requirement is to establish a full service

centralized coordinating center to manage a multi-center clinical

trial to evaluate the efficacy of this botanical (hypericum) in

patients with depression.


The offeror will be responsible for recruiting sites from a range of

diverse environments including clinical, university and research

settings. Unlike many other clinical trials, most patients eligible

for this study will not be treated in a university clinic but rather

in private practice offices or in managed care settings.  The

contractor  must have established working relationships and a

consortium of mental health care providers readily available.  The

use of hypericum has generated a substantial amount of recent

interest in the media, which makes it imperative that sites are

identified which can begin recruiting patients within a limited

period after award.


The successful offeror shall: 1) have available staff resources to

provide the medical expertise necessary for medical monitoring and

oversight of the trial; 2) finalize the study design and protocol; 3)

monitor patient recruitment and site compliance with the study

protocol; 4) provide standardized data forms and perform all

necessary data management activities (scheduling, monitoring,

collecting, editing data from each of the clinical sites, etc.); 5)

ensure patient safety; 6) maintain standardization across sites; 7)

prepare and analyze the composite data set; and 8) perform all other

activities necessary to coordinate trial activities.


NIMH proposes to issue an unrestrictive competitive solicitation for

this requirement and anticipates the award of a cost reimbursement

contract for a period of three years.




Request for Proposal (RFP)  No. NIMH-97-CR-0007 will be available

electronically on or about June 5, 1997, with proposals due on or

about July 21,1997.  The RFP may be accessed through either the NIH

Home Page, the NIH Gopher or the NIMH Home Page by using the

following electronic addresses and instructions:


1.  NIH Home Page (via the World Wide Web):  Access the NIH Home Page

by using  Once you are at the NIH Home Page,

select "Grants and Contracts," then select "NIH Gopher directory,"

item listed under the "Contracts Page" Section.  The Uniform Resource

Locator (URL) for this gopher director is



2.  To access the NIH Gopher:  Point your gopher client to

GOPHER.NIH.GOV (you should now be in the NIH Gopher). Select "Grants

and Research Information," then select "R&D Requests for Proposals



3.  NIMH Home Page: Access the NIMH Home page by using  Once you are there, select "Grants,

Contracts & Committees," item listed under "NIMH Request for

Proposals (RFP)."


Please note that the RFP for this procurement has been revised to

include only the Statement of Work, deliverable and reporting

requirements, special requirements and mandatory qualifications, if

any, the Technical Evaluation Criteria, and proposal preparation

instructions.  All information required for the submission of an

offer will be contained in the electronic RFP package.  Following

proposal submission and the initial review process, offerors

comprising the competitive range will be requested to provide

additional documentation to the Contracting Officer. All responsible

sources that submit a proposal will be considered by the NIMH.



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