Biological Materials

	Biological material application generated by the research study shows benefit during clinical trials Biological material application generated by the research study registered/licensed with FDA Biological material application generated by the research study used by health care providers and/or consumers

The definition of biological materials for this purpose is expansive and includes cells and biological entities as well as those substances described as biologics, biological factors, and biological products.

Cells and Biological Entities

Cells are defined by the National Library of Medicine as the fundamental, structural, and functional units or subunits of living organisms. Included in this group are transformed, hybrid, and tumor cell lines, as well as stem cells, among others. The term “biological entity” is a broad term. Biological entities for this purpose include biological materials typically described as an “organism” as well as non-living entities such as viruses. An organism may be defined as an individual that is capable of carrying out all of life’s functions, such as growth, homeostasis, and reproduction. Included in this group are animal disease models.

Biologics

Biologics are biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies. Biologics, in contrast to drugs that are chemically synthesized, are derived from living sources (such as humans, animals, and microorganisms), are not easily identified or characterized, and many are manufactured using biotechnology according to the Center for Biologics Evaluation and Research (CBER), a Center within the Food and Drug Administration.

Biological Factors

The National Library of Medicine defines biological factors as endogenously-synthesized compounds that may influence biological phenomena or represent quantifiable biomarkers. Biological factors are a variety of extracellular substances that are not otherwise classified under enzymes, hormones, or hormone antagonists. Included in this definition are antigens, biological markers, blood coagulation factor inhibitors, blood coagulation factors, chemotactic factors, inflammation mediators, intercellular signaling peptides and proteins, pheromones, pigments, and biological toxins.

Biological Products

The National Library of Medicine defines biological products as complex pharmaceutical substances, preparations, or agents of organic origin, usually obtained by biological methods or assay. They are used especially in diagnosis and treatment of disease (as vaccines or pollen extracts). Biological products are differentiated from biological factors in that the latter are compounds with biological or physiological activity made by living organisms. Included in this definition are antitoxins, immune sera, menotropins, Picibanil, plant exudates and preparations, and vaccines.

Use of biological materials and applications that demonstrate efficacy in the delivery of health care services is evidence of clinical implementation. These materials are diverse as are their potential applications.

Assessment

Comprehensive review of the literature is required to locate biological materials and applications that have demonstrated efficacy in clinical studies or those that are currently in use in clinical applications for treatment of a disease, condition or disorder.

	Search using the keywords of the biological material or application, title or the name of the author/research study that developed or created the initial material or application.

Some resources that may be helpful include the following:

Center for Biologics Evaluation and Research (CBER)

Center for Biologics Evaluation and Research (CBER), operated by the FDA, is responsible for ensuring the safety and efficacy of blood and blood products, vaccines, allergenics, and biological therapeutics. CBER’s regulation of biological products has expanded in recent years to include a wide variety of new products such as biotechnology products, somatic cell therapy and gene therapy, and human cells, tissue and cellular and tissue-based products. CBER’s mission is to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies. Biologics, in contrast to drugs that are chemically synthesized, are derived from living sources (such as humans, animals, and microorganisms), are not easily identified or characterized, and many are manufactured using biotechnology. These products often represent cutting-edge biomedical research and, in time, may offer the most effective means to treat a variety of medical illnesses and conditions that presently have few or no other treatment options.

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. The 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

Drugs@FDA Database

Drugs@FDA allows for searching of official information about FDA approved brand name and generic drugs and therapeutic biological products using the following criteria:

• drug name
• generic name
• active ingredient
• drug name and FDA Action Date range
• application number (NDA, ANDA, BLA)
• action dates of approvals and supplements in one, two, or three month blocks
• original and supplemental approvals by month

 

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Last updated: June 1, 2009