Book:The Laboratories of Our Lives: Labs, Labs Everywhere!/Labs by industry: Part 2/Clinical and academic research

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4. Labs by industry: Part 2

We continue to look at 20 broad industry categories and the laboratories associated with them. For each you'll find a brief description with common services and how the lab type affects the average person. As discussed previously, using our client type + function model we dig into examples found in the private, government, and academic sectors and then outline function through activities, sciences, test types, equipment, and unique attributes. Finally, we discuss the role of informatics in each industry lab type.

4.1 Clinical and academic research

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Clinical research laboratories provide a regulated environment for the testing of the safety and efficacy of a variety of medical treatments and diagnostic devices, including medications, implants, and physician test kits. These facilities form the backbone of today's effective medical treatments, from cholesterol-lowering medications to pacemakers for the heart. In the U.S., these types of labs are overseen by the Food and Drug Administration (FDA), unlike the previously mentioned clinical and public health laboratories. Clinical research labs are found in the private, government, and academic sectors and provide many different services, including (but not limited to)[1][2]:

  • clinical studies
  • bioequivalence studies
  • study design and management
  • high-volume specimen testing
  • custom assay development
  • test kit development and supply

Clinical studies and trials aside, other types of research may require laboratory services as well. (For the purposes of this guide, we refer to it as "academic research," a broad catch-all category for other research involving laboratories that doesn't readily fit into other industry categories.) Take for example the archeology laboratory, which is responsible for cleaning, analyzing, and identifying artifacts and remains from various sites either as part of a greater research effort or as a contract laboratory service.[3][4] Research in information and communications technology (ICT) also occurs in dry laboratories; examples include the privately owned Nokia Bell Labs[5] and the university-affiliated University of New Hampshire InterOperability Laboratory.[6]

But how do clinical and academic research laboratories intersect the average person's life on a daily basis?

If you've had a medical device implanted, taken a prescription medication, visited an archeological exhibit in a museum, or experienced improvements in how you use technology to communicate with others, then you've been touched by a clinical or academic research laboratory. Without these facilities we'd have fewer medications and assistive devices, and by extension shorter life spans. We'd know less about humanity's past growth and development, and we'd lack the technology to rapidly disseminate those findings around the globe.

4.1.1 Client types

Private - Private clinical research labs are most often "central laboratories" (see the end of this section for more on this term) that are contracted by pharmaceutical companies and medical device manufacturers.

Examples include:

Government - These labs are typically set up by a government agency to perform specific research into medical conditions such as cancer, depression, or HIV infection.

Examples include:

Academic - Many academic institutions set up their own clinical research activities, often within an affiliated medical center. These research efforts often serve as training grounds for students to learn more about clinical research and its administration.

Examples include:

4.1.2 Functions

What are the most common functions? analytical, QA/QC, research/design, and teaching

What materials, technologies, and/or aspects are being analyzed and researched? artifacts, biological specimens, chemicals, communication networks, medical devices, pharmaceuticals, etc. (depending on academic discipline practiced in the lab and type of research)

What sciences are being applied in these labs? archeology, clinical chemistry, clinical microbiology, clinical research, immunology, information theory, molecular biology, pharmacology, etc. (depending on academic discipline practiced in the lab and type of research)

What are some examples of test types and equipment?

Common test types include:

Absorption, Acoustic startle, Acute contact, Acute oral, Acute toxicity, Adhesion, Age determination, Amino acid analysis, Angle of repose, Antimicrobial, Antigen, Behavioral, Blood culture, Blood gases, Bioavailability, Bioburden, Biocompatibility, Bioequivalence, Biomechanical, Biomolecular, Biosafety, Calorimetry, Carcinogenicity, Clinical diagnostic, Colorimetric, Compaction, Compendial, Complete blood count, Cytology, Cytopathology, Cytotoxicity, Detection, Developmental and reproductive toxicology, Dietary exposure, Ecotoxicology, Efficacy, Electrolyte and mineral panel, Electromagnetic compatibility, Electromagnetic interference, Electrophoresis, Endocrine disruptor screening program, Endotoxin, Environmental fate, Environmental metabolism, Extractables and leachables, Feasibility, Fluid dynamics, Functional observational battery, Genetic, Genotoxicity, Hematocrit, Hemoglobin, Hematotoxicity, Human factors, Immunohistochemistry, Impact, Impurity, Inhalation, Irritation, Kidney function, Learning and memory, Lipid profile, Liver function, Locomotor activity, Metabolic, Microfluidics, Minimum bactericidal concentration, Minimum inhibitory concentration, Nanoparticulate, Neurotoxicity, Nutritional, Osmolality, Osmolarity, Oxidation reduction potential, Oxidation stability, Parasitic, Pathogen, Pathogenicity, pH, Pharmacokinetic, Phototoxicity, Protein analysis, Protein characterization, Red blood cell count, Refractive index, Sensitization, Solubility, Specific gravity, Thyroid function, Toxicokinetic, Urine culture, Validation, Verification, Virucidal efficacy, Wildlife toxicology

Industry-related lab equipment may include:

autoclave, balance, biohazard container, biosafety cabinet, centrifuge, chromatographic, clinical chemistry analyzer, colorimeter, desiccator, dissolved oxygen meter, dry bath, electrophoresis system, ELISA plate reader, fluorometer, freezers, fume hood, genetic analyzer and sequencer, homogenizer, hotplate, incubator, magnetic stirrer, mass spectrometry equipment, microcentrifuge tube, microplate reader, microscope, multi-well plate, orbital shaker, PCR machine, personal protective equipment, pH meter, Petri dish, pipettor, powered air purifying respirators, refractometer, spectrophotometer, syringes, test tube and rack, thermal cycler, thermometer, urinalysis device, water bath

What else, if anything, is unique about the labs in the clinical and academic research fields?

It's important to note that some clinical research laboratories may be referred to as "central laboratories." Though mentioned occasionally in its regulation and guidance, the U.S. Food and Drug Administration doesn't seem to provide a definition of the term. However, it seems to be used by some in the context of an analytical laboratory that provides analyses of biological specimens associated with clinical and bioequivalence studies (including multi-site studies, prompting the idea of a "central" lab handling sample analysis) performed at medical institutions.[1][7]

4.1.3 Informatics in the clinical and academic research industry

On the clinical research side, informatics is being used in a variety of ways. Clinical research informatics—described by the American Medical Informatics Association (AMIA) as "the use of informatics in the discovery and management of new knowledge relating to health and disease"[8]—is allowing researchers to better use data from clinical trials, improve biomedical research techniques, and analyze and visualize the massive amount of data that comes from said techniques.[9] Efforts to create research data management applications occur not only within businesses but also academic sectors, including Duke University's Office of Academic Solutions and Information Systems (formerly the Office of Research Informatics)[10] and University of Chicago's Center for Research Informatics[11]

Informatics appear in other types of non-clinical, academic research. Take for instance the field of computational archaeology (also known as archaeological informatics), allowing archaeologists "to present dynamic phenomena, to show processes in action rather than static descriptions of them, and to vary the narratives to respond to the needs, experience and interests of our varied audiences without necessarily sacrificing the archaeological integrity of our arguments."[12]

4.1.4 LIMSwiki resources further reading

LIMSwiki resources

Further reading


  1. 1.0 1.1 "Definition of Central Laboratory". FDA Good Clinical Practice (GCP) Q&A. Model Agreements & Guidelines International. 19 April 2004. Archived from the original on 08 January 2020. Retrieved 28 June 2022. 
  2. Minor, L.K., ed. (2006). "Handbook of Assay Development in Drug Discovery". CRC Press. pp. 488. ISBN 9781420015706. 
  3. "Archeology Laboratory". Augustana University. Retrieved 28 June 2022. 
  4. "Labs". Saint Louis University. Retrieved 28 June 2022. 
  5. "History - Bell Labs". Nokia Group. Retrieved 28 June 2022. 
  6. "UNH-IOL FAQ". University of New Hampshire InterOperability Laboratory. Retrieved 28 June 2022. 
  7. Karelin, A.; Belotserkovskiy, M.; Khokhlova, V.; Kumar, A. (6 May 2013). "Selecting a Central Laboratory". Contract Pharma. Rodman Media, Inc. Retrieved 28 June 2022. 
  8. "Informatics: Research and Practice". American Medical Informatics Association. Retrieved 28 June 2022. 
  9. Embi, P.J.; Payne, P.R. (2009). "Clinical research informatics: Challenges, opportunities and definition for an emerging domain". JAMIA 16 (3): 316–27. doi:10.1197/jamia.M3005. PMC PMC2732242. PMID 19261934. 
  10. "Office of Academic Solutions and Information Systems". Duke University. Retrieved 28 June 2022. 
  11. "Center for Research Informatics". University of Chicago. Retrieved 28 June 2022. 
  12. Huggett, J.; Ross, S. (2004). "Introduction". Internet Archaeology (15): 13. doi:10.11141/ia.15.13.