Assessing the Impact of Research Becker Medical Library Washington University School of Medicine
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Pharmaceutical Preparations

Evidence of Transfer
  • Subsequent use of a drug generated by the research study in a bench study (basic science) or clinical trial study
  • Clinical data is generated in support of marketing a drug (Investigational New Drug Application, IND; New Drug Application, NDA; Abbreviated New Drug Application, ANDA; or 505(b)(2)) generated by the research study

Pharmaceutical Preparations are defined by the National Library of Medicine as drugs intended for human or veterinary use, presented in their finished dosage form. Pharmaceutical preparations can be considered as biological material applications when they reflect an approach based on understanding of details at the molecular level.

If a drug moves beyond the pre-clinical testing then it is ready for testing on humans during clinical trial studies in a series of studies, Phases I through III.

Assessment

Documentation by research study investigators of clinical and bench trials in process or clinical data generated in relation to a drug is recommended for tracking of knowledge transfer.

Comprehensive review is required to locate drugs that are being tested in clinical studies or involved in bench studies.

Search Tip Search using the keywords, name of drug, name of manufacturer, title or the name of the author/research study.

Some resources that may be helpful include the following:

CenterWatch Drugs in Clinical Trials

The CenterWatch Drugs in Clinical Trials Database is a comprehensive online resource offering detailed profiles of new investigational treatments in phase I through III clinical trials. Updated weekly, the online directory provides information on more than 3,000 drugs for more than 800 disease conditions worldwide in a well-organized and easy-to-reference format. Detailed profile information is provided for each drug.

Clinical Study Results

Clinical Study Results is a central, widely accessible, web-based repository for clinical study results. The database contains results from all “hypothesis-testing” clinical studies (mainly phase III and IV studies) completed since October 1, 2002, for drug products approved in the United States. This includes both published articles and unpublished study summaries. The information provided includes the sponsoring company’s name, the proprietary and generic names of the drug, a link or reference to the FDA-approved drug label, the studied indication(s), a bibliography of published studies together with a link (where available) to the printed articles, and a summary of the results of clinical studies that have not been published. This summary presentation will include information on the drug such as the design of the trial, the number of patients studied, the dose and mode of administration, and a summary of conclusions and outcomes on the safety and efficacy of the drug.

Clinical Trials.gov

The Clinical Trials.gov database allows for searching by a number of criteria including interventions which allows for a search for a specific drug, device, procedure or vaccine. Clinical Trials.gov includes clinical trials from all sources of funding and from over 157 countries.

Cochrane Library – Clinical Trials

The Cochrane Library consists of a regularly updated collection of evidence-based medicine databases to inform healthcare decision-making. Cochrane provides additional resources such as other systematic reviews, abstracts, technology assessments, economic evaluations, and individual clinical trials.

The Cochrane Library offers a Clinical Trials database that allows for searching of clinical trials as noted in MEDLINE and EMBASE and from other published and unpublished sources. From the main page of the Cochrane Library, select the Clinical Trials resource. Search tips are noted on the main page of the Clinical Trials database.

Cochrane Library home page

Cochrane Library home page

PhRMA New Medicines

According to the PhRMA New Medicines Database, over 2,000 medicines are in the development stages. Each new medicine requires an average of 10-15 years of testing and review. PhRMA’s New Medicine Database includes medicines currently in clinical trials or at FDA undergoing review.

PubMed

PubMed is a freely accessible online database of biomedical journal citations and abstracts created by the U.S. National Library of Medicine (NLM). Approximately 5,200 journals published in the United States and more than 80 other countries are indexed in PubMed. Follow directions for searching as noted.

PubMed offers filters for searching of clinical trials. From the main page, click Advanced Search and select the type of clinical trial you want to search for under the Type of Article options box. Options include Clinical Trial, Randomized Controlled Trial, Controlled Clinical Trial, and Clinical Trial, Phases I, II, III, or IV.

PubMed Advanced Search Menu page showing type of article filter

PubMed Advanced Search Menu page showing type of article filter

 

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Last updated: June 1, 2009