Investigational Drug Information

1974 ◽  
Vol 8 (4) ◽  
pp. 182-183
Author(s):  
Larry M. Kleinman ◽  
Joseph A. Tangrea ◽  
Joseph F. Gallelli
Keyword(s):  
Clinical Research ◽  
Drug Administration ◽  
Drug Information ◽  
Food And Drug Administration ◽  
National Institutes Of Health ◽  
Investigational Drug ◽  
Fact Sheet ◽  
Research Protocols ◽  
Clinical Center ◽  
Investigational Drugs

The drug information appearing in this column is for investigational drugs studied in clinical research protocols being pursued in the Clinical Center at the National Institutes of Health. This same information, in the form of an “Investigational Drug Fact Sheet,” is distributed, prior to its use, to the dispensing pharmacist and the appropriate nursing units involved in the administration of the drug As with all investigational drugs, the drugs reported in this column have a Notice of Claimed Investigational Exemption for o New Drug (IND) assigned to them by the Food and Drug Administration (F.D.A.).

Investigational Drug Information

1974 ◽  
Vol 8 (1) ◽  
pp. 25-26
Author(s):  
Larry M. Kleinman ◽  
Joseph A Tangrea ◽  
Joseph F. Gallelli
Keyword(s):  
Clinical Research ◽  
Drug Administration ◽  
Drug Information ◽  
Food And Drug Administration ◽  
National Institutes Of Health ◽  
Investigational Drug ◽  
New Drug ◽  
Research Protocols ◽  
Clinical Center ◽  
Investigational Drugs

The drug information appearing in this column is for investigational drugs studied in clinical research protocols being pursued in the Clinical Center at the National Institutes of Health. As with all investigational drugs, the drugs reported in this column have a Notice of Claimed Investigational Exemption for a New Drug (IND) assigned to them by the Food and Drug Administration (F.D.A.).

HIV

2018 ◽  
Author(s):  
Joshua M. Sharfstein
Keyword(s):  
Public Health ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Research Process ◽  
National Institutes Of Health ◽  
Health Agencies ◽  
Act Up ◽  
The U.S

The emergence of AIDS in the early 1980s caused a profound crisis for federal health agencies, particularly the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA). Activists in ACT UP, charging that these agencies were failing patients with AIDS, initiated a series of escalating protests. NIH officials, led by Dr. Anthony Fauci, began to talk with the advocates and make major changes in the research process. However, over at the FDA, a protest involving the arrest of hundreds of AIDS activists undermined the agency’s public health image. Eventually, under a new commissioner, the FDA earned back the trust of activists.

Are Investigational Drugs Getting you Down? One Hospital's Solution to the Increasing Number of Clinical Research Studies

2003 ◽  
Vol 38 (2) ◽  
pp. 140-143 ◽  
Author(s):  
Christine D. Sybert
Keyword(s):  
Clinical Research ◽  
Drug Acquisition ◽  
Investigational Drug ◽  
Clinical Research Center ◽  
Investigational Drugs ◽  
Part Time ◽  
Important Means ◽  
Acquisition Costs ◽  
Drug Studies ◽  
Clinical Drug

This article describes the process and results of employing an Investigational Drug Service Pharmacist (IDSP) to coordinate pharmacy support for clinical drug studies. In 1998, a Clinical Research Center (CRC) was established to coordinate all research at a 407-bed Baltimore teaching hospital, resulting in an increase in studies requiring pharmacy support. By the end of 1998, there was a backlog of nine studies awaiting review for feasibility and impact on pharmacy resources. A lack of communication between departments further impeded the process. In March 1999, a part-time pharmacist was hired to coordinate all drug studies; the pharmacist's salary was paid by the CRC. Primary responsibilities of the position were protocol review, staff education, and drug accountability. Dispensing was still handled by staff pharmacists. After three years, results were as follows: 72 studies were reviewed, 41 were opened for enrollment, 8 were in preparation, 16 were completed. Two studies alone have saved the pharmacy department over $80,000 in drug acquisition costs. The efforts of the IDSP have helped the CRC to more than double its growth, with gross income from studies of $533,712 in 2001 compared with only $237,663 in 1998. The IDSP has improved communication between the CRC and pharmacy and expedited study initiation. It has also made the CRC more attractive to prospective sponsors, since one pharmacist works directly with study coordinators. With more physicians interested in carrying out research and hospital budgets becoming tighter, the part-time IDSP position represents an important means of supporting these endeavors without increasing fiscal burdens.

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