NIH Guide, Volume 22, Number 13, April 2, 1993


P.T. 34


  Clinical Medicine, General 


National Institute on Drug Abuse

The National Institute on Drug Abuse (NIDA) is soliciting proposals

from organizations capable of selecting sites for the conduct of

clinical trials and supervising their operation.  These will be Phase

I and II trials, primarily for the treatment of cocaine and opiate

addiction under the current Food and Drug Administration (FDA)

regulations and Good Clinical Practice (GPC) guidelines.  Performance

of the work shall involve:  protocol development and review;

solicitation and recruitment of a network of qualified clinical trial

centers; obtaining FDA registration, DEA registration, and ongoing

regulatory compliance; initiation, coordination, monitoring, and

management of clinical trials; selection of a central pharmacy and

supervision of the distribution of clinical supplies; selection of a

central laboratory to accomplish the routine laboratory tests (e.g.,

CBC, urinalysis) performed at the clinical center; data management;

clinical and statistical analysis; and preparation of a written study

summary report of adequate quality to support NDA submission(s).  The

nature of the clinical trials will be to determine the tolerated dose

range, the dosing regimen, the safety profile, and estimates of

pharmacokinetics and pharmacodynamic parameters.  The contractor also

will evaluate the efficacy of the investigational compounds or marketed

medications.  Estimated issuance date of RFP No. N01DA-3-8400 is April

16, 1993, and responses are due to be received by the Contracting

Officer 45 calendar days thereafter.  The NIDA plans to make one award

from this solicitation.


Written requests are to be forwarded to:

Kenneth E. Goodling, Contract Specialist

National Institute on Drug Abuse

Parklawn Building, Room 10-49

5600 Fishers Lane

Rockville, MD  20857

This advertisement does not commit the Government to make an award.


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