CLINICAL TRIALS AND STATISTICAL STUDY MONITORING AND COORDINATION

NIH GUIDE, Volume 24, Number 17, May 12, 1995



RFP AVAILABLE:  NIH-EY-95-07



P.T.





Keywords:



National Institutes of Health



The National Institutes of Health (NIH) has a requirement for

Clinical Trials and Statistical Study Monitoring and Coordination for

Ophthalmic Clinical Trials.  The contractor shall provide clinical

trial design, study design, sample size calculations, and

identification of appropriate study endpoints and statistical

analyses.  Reading center services for the evaluation of photographs

and fluorescein angiograms will also be required.  Other required

services include:  development and preparation of protocols,

collection of data elements and analysis of study data including

standard statistical techniques utilized in the analysis of clinical

trials, preparation of reports by protocol, as well as comprehensive

reporting of treatment-related toxicity, notification of protocol

violations or reported toxicities of investigational drugs, clinic

coordinators to assist in the conduct of trials, assistance in the

design of a computerized system to organize clinical data collected

during ocular examinations, the capability of reproducibly analyzing

external and internal ophthalmic photographs and fluorescein

angiograms of study patients, and assistance in the development and

preparation of publicity materials for clinical trials to improve

patient recruitment.  The requirement also includes natural history

and outcomes research studies involving as many as 10 clinics.  The

contractor shall support these studies by providing assistance in the

retrieval, formatting and analysis of information for the

interpretation and evaluation of data.  Integrity of research must be

protected including assuring patient safety through a data and safety

monitoring committee.  Personnel must be well qualified in ophthalmic

epidemiology and clinical trials.



INQUIRIES



Request for Proposal (RFP) NIH-EY-95-07 will be available 15 days

from the date of this publication.  Written requests may be submitted

to:



Karen Gamble

Research Contracts Branch

National Institutes of Health

6100 Executive Boulevard, Room 6E01

Bethesda, MD  20892

FAX:  (301) 402-0178



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