Connect with PSBR!

 

 facebook40x40 pinterest40x40 twitter40x40 Linkedin40x40 insta2-40x40 email-40x40

Donate Now

 

PayPal 

Member Sign In

Log in now to access all information available to PSBR members.

Research Methods

Biomedical research is the broad area of science devoted to the study of the processes of life, the prevention and treatment of disease, and the genetic and environmental factors related to disease and health. It involves the investigation of biological processes and the causes of disease in humans and animals through careful experimentation, observation, analysis, laboratory work, and testing. Biomedical researchers look for ways to prevent, treat, and cure diseases that cause illness and death in people and animals.

 

Basic Research- This research is done to increase our fundamental knowledge of how the processes in living organisms function and develop. This research provides the building block upon which other types of biomedical research (applied and clinical) are based.

 

Applied Research- This research is directed towards specific objectives and discoveries, such as the development of a new drug, therapy, medical device, or surgical procedure. It involves using existing knowledge (obtained from basic research) and applying it to a specific biomedical problem. This research can be done with animals, non-animal alternatives (computers, cell/tissue cultures), or with humans.

In vitro research- (Latin for “in the glass") is research done with bacteria, cell, tissue, and organ cultures done in laboratories.

Ex vivo research- (Latin for “out of the living") is research done in or on living cells or tissues from an organism and cultured in a laboratory, outside of the living organism. The cultures can serve as models of the entire organism, helping to reduce the need for in vivo research.

In vivo research- (Latin for “in the living") is research done in a whole organism. Pre-clinical trials and clinical trials are examples of this research.

 

Translational Research- The scope of translational research is relatively new so definitions of the term tend to vary. Translational research- between basic science and clinical trials- involves transforming laboratory findings into new ways to diagnose and treat patients that can be used clinically or brought to the market for commercialization. The first application for the National Institutes of Health's Clinical and Translational Science Awards (CTSAs) defined translational research as:

Translational research includes two areas of translation. One is the process of applying discoveries generated during research in the laboratory, and in preclinical studies, to the development of trials and studies in humans. The second area of translation concerns research aimed at enhancing the adoption of best practices in the community.

The key to translational research is to make sure the advances and discoveries made in the laboratory and in preclinical studies find their way into the clinic and into the lives of the patients for whom they are intended and that the treatments are properly implemented. This refers to the “bench-to-bedside" approach that involves taking knowledge from basic science research to produce new drugs, devices, and treatments for patients. For more information, see an article by JAMA- The Meaning of Translational Research and Why It Matters.

 

Pre-clinical trials- This involves non-human animal models to help expand our knowledge of more effective methods for diagnosing, treating, and curing diseases that can affect both humans and animals. Researchers use animal models in more advanced levels of biomedical research because animals are biologically similar to humans and are susceptible to many of the same diseases.

 

Clinical Trials- These involve human volunteers and take place in a hospital or clinical setting. These trials can take place after the drug/compound has passed safety testing in animals. The human volunteers allow researchers to gauge the effectiveness and safety of new drugs, procedures, or medical devices. There are 3 major phases of clinical trials that are done in coordination with the US Food and Drug Administration (FDA).

If it successfully makes it through all 3 phases, it may be submitted for approval for use to the FDA who will approve or reject it based on the data obtained from the clinical trials. If approval is given, monitoring continues indefinitely while the drug is on the market.

Phase I- Consists of drug safety studies in healthy human volunteers. The goals are to make sure the medicine has no major safety issues, and that it reaches the targeted body area and remains there long enough to benefit the patient.

Phase II- Tests whether a drug works in a small number of patients affected by the disease. (Sometimes patients not affected by the disease are used in this stage when appropriate.) The goals are to study the effectiveness of the medicine's ability to treat the disease (or prevent it), and to find the appropriate dosage level.

Phase III- Tests whether the drug works in a large number of patients affected by the disease. The goals are to show the safety and effectiveness of the medicine, to confirm dosage levels, identify side effects, build knowledge of the medicine benefits and risks, and to compare the results against any existing treatments.

Post-Marketing Surveillance- The drug maker and the FDA continue to monitor the drug for side effects while it is on the market. Drugs are taken off the market if previously undetected side effects occur.

 

Note: Each new medicine is tested on approximately 15 times as many people as animals.

 

The drug discovery process can take up to 15 years or more to progress from finding a disease target to getting FDA approval. Basic research and preclinical trials can last about 3-6 years. Clinical trials can last about 6-7 years. FDA approval can take anywhere from ½-2 years. Post marketing surveillance is done the entire time the drug is on the market.

 

Click here to view a great infographic from FASEB on the drug development process.

Click here to view a GSK infographic on the drug development process. Click here to view GSK's webpage further explaining the drug development process.

Click here to view a PDF from Understanding Animal Research that explains how new medicines are discovered, and the small but vital role animals play in this process.

 

clickforPDF