Drugs

Definition

Pharmaceutical products for human or veterinary use. 

Rationale

New drugs developed as a result of translational research is a critical component of the emphasis to improve and reduce the process of scientific discovery to useful clinical applications. A review of the drug development timeline can identify successful research process practices to be utilized by other translational science research teams. 

Guidance

Advice from authors on searching for information:

Self-reported knowledge of research study researchers is helpful to document new drug development in progress and for tracking drugs that have demonstrated efficacy in pre-clinical or clinical studies, those that have gained FDA approval, or those that are currently in use in clinical applications for treatment of a disease, condition, or disorder. 

Resources & Data

Organizations, repositories, websites, and other sources where you can find more information:

Local

Center for Research Innovation in Biotechnology
The Center for Research Innovation in Biotechnology provides a database of new molecular entities approved by the FDA, including information on their sponsors, indications and targets.   

Office of Technology Management at Washington University (OTM)  
The OTM Technology Catalog allows for searching of new drugs developed by researchers at Washington University and lists the drug name, a description of the drug, patent status, and researcher/s name.  

General

ClinicalTrials.gov
ClinicalTrials.gov is a registry and results database.  It allows for searching for specific drugs, disease or condition, and study title among others.  It has study data from over 200 countries.

Cochrane Central Register of Controlled Trials (CENTRAL)
CENTRAL provides searchable reports of randomized and quasi-randomised controlled trials as noted in MEDLINE, Embase, and from other published and unpublished sources.

Drugs@FDA
Drugs@FDA lists most prescription and over-the-counter (OTC) drug products approved since 1939. Drugs@FDA helps consumers find generic equivalents and other possible appropriate alternatives to their approved products as well as the product’s drug label. Drugs@FDA Demo provides an overview of using Drugs@FDA.

Green Book
The FDA “Green Book” contains a list of all FDA approved animal drug products. 

Orange Book
The FDA “Orange Book” contains drugs approved by FDA under New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs).

WHO Pharmaceutical Products
WHO pharmaceutical products lists of current drugs in pharmaceutical use by world region

WHO List of Essential Medicines
WHO list of essential medicines provides information on drugs considered essential by the organization

Data Limitations

Challenges you may encounter while searching for information:

Access to self-reported researcher or administrative/in-house data may be required to locate documentation.

Publications

Articles, books, and other publications in translational science using the indicator:

Buxton M, Hanney S. How can payback from health services research be assessed? J Health Serv Res Policy 1996;1(1):35-43. doi: 10.1177/135581969600100107.

Donovan C, Butler L, Butt AJ, et al. Evaluation of the impact of National Breast Cancer Foundation-funded research. Med J Aust. 2014;200(4):214-218. doi: 10.5694/mja13.10798.

Hanney SR, Watt A, Jones TH, et al. Conducting retrospective impact analysis to inform a medical research charity’s funding strategies: the case of Asthma UK. Allergy Asthma Clin Immunol. 2013;9:17. doi: 10.1186/1710-1492-9-17.

Kuruvilla S, Mays N, Pleasant A, et al. Describing the impact of health research: a research impact framework. BMC Health Serv Res. 2006 Oct 18;6:134. doi: 10.1186/1472-6963-6-134.

Case Studies

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