Biomedical research (or experimental medicine), in general simply known as medical research, is the basic research Basic research or fundamental research is research carried out to increase understanding of fundamental principles. Many times the end results have no direct or immediate commercial benefits: basic research can be thought of as arising out of curiosity. However, in the long term it is the basis for many commercial products and applied research, applied research Applied research is research that is applied, accessing and using some part of the research communities' accumulated theories, knowledge, methods, and techniques, for a specific, often state, commercial, or client driven purpose. Applied research is often opposed to pure research in debates about research ideals, programs, and projects, or translational research Translational research is another term for translative research and translational science, although it fails to disambiguate itself from forms of research that are not scientific , which are currently considered outside its scope. Translational research is a way of thinking about and conducting scientific research to make the results of research conducted to aid and support the body of knowledge in the field of medicine Medicine is the science and art of healing. It encompasses a range of health care practices evolved to maintain and restore health by the prevention and treatment of illness. Before scientific medicine, healing arts were practised in accordance with alchemical treatments and ritual practices that developed out of religious and cultural traditions. Medical research can be divided into two general categories: the evaluation of new treatments for both safety and efficacy in what are termed clinical trials Clinical Trials are conducted to allow safety and efficacy data to be collected for health interventions . These trials can take place only after satisfactory information has been gathered on the quality of the non-clinical safety, and Health Authority/Ethics Committee approval is granted in the country where the trial is taking place, and all other research that contributes to the development of new treatments. The latter is termed preclinical research Pre-clinical development is a stage of research that begins before clinical trials can begin, and during which important feasibility, iterative testing and safety (also known as Good Laboratory Practice or "GLP") data is collected if its goal is specifically to elaborate knowledge for the development of new therapeutic strategies. A new paradigm to biomedical research is being termed translational research Translational research is another term for translative research and translational science, although it fails to disambiguate itself from forms of research that are not scientific , which are currently considered outside its scope. Translational research is a way of thinking about and conducting scientific research to make the results of research, which focuses on iterative feedback loops between the basic and clinical research domains to accelerate knowledge translation from the bedside to the bench, and back again.

The increased longevity of humans over the past century can be significantly attributed to advances resulting from medical research. Among the major benefits have been vaccines Vaccines can be prophylactic , or therapeutic (e.g. vaccines against cancer are also being investigated; see cancer vaccine) for measles Measles is an infection of the respiratory system caused by a virus, specifically a paramyxovirus of the genus Morbillivirus. Morbilliviruses, like other paramyxoviruses, are enveloped, single-stranded, negative-sense RNA viruses. Symptoms include fever, cough, runny nose, red eyes and a generalized, maculopapular, erythematous rash and polio Poliomyelitis, often called polio or infantile paralysis, is an acute viral infectious disease spread from person to person, primarily via the fecal-oral route. The term derives from the Greek poliós , meaning "grey", myelós (µυελός), referring to the "spinal cord", and the suffix -itis, which denotes inflammation, insulin Insulin is a hormone that is central to regulate energy and glucose metabolism in the body. Insulin causes cells in the liver, muscle, and fat tissue to take up glucose from the blood, storing it as glycogen in the liver and muscle treatment for diabetes Diabetes mellitus, often simply referred to as diabetes—is a condition in which a person has high blood sugar, either because the body does not produce enough insulin, or because cells do not respond to the insulin that is produced. This high blood sugar produces the classical symptoms of polyuria , polydipsia (increased thirst) and polyphagia (, classes of antibiotics In common usage, an antibiotic is a substance or compound that kills bacteria or inhibits their growth. Antibiotics belong to the broader group of antimicrobial compounds, used to treat infections caused by microorganisms, including fungi and protozoa for treating a host of maladies, medication for high blood pressure Blood pressure is a force exerted by circulating blood on the walls of blood vessels, and is one of the principal vital signs. During each heartbeat, BP varies between a maximum (systolic) and a minimum (diastolic) pressure. The mean BP, due to pumping by the heart and resistance in blood vessels, decreases as the circulating blood moves away from, improved treatments for AIDS Acquired immune deficiency syndrome or acquired immunodeficiency syndrome is a disease of the human immune system caused by the human immunodeficiency virus (HIV). This condition progressively reduces the effectiveness of the immune system and leaves individuals susceptible to opportunistic infections and tumors. HIV is transmitted through direct, statins They lower cholesterol by inhibiting the enzyme HMG-CoA reductase, which is the rate-limiting enzyme of the mevalonate pathway of cholesterol synthesis. Inhibition of this enzyme in the liver results in decreased cholesterol synthesis as well as increased synthesis of LDL receptors, resulting in an increased clearance of low-density lipoprotein and other treatments for atherosclerosis Atherosclerosis is a condition in which an artery wall thickens as the result of a build-up of fatty materials such as cholesterol. It is a syndrome affecting arterial blood vessels, a chronic inflammatory response in the walls of arteries, in large part due to the accumulation of macrophage white blood cells and promoted by low-density, new surgical techniques such as microsurgery Microsurgery is a general term for surgery requiring an operating microscope. The most obvious developments have been procedures developed to allow anastomosis of successively smaller blood vessels and nerves which have allowed transfer of tissue from one part of the body to another and re-attachment of severed parts. Although microsurgery is used, and increasingly successful treatments for cancer Cancer /ˈkænsər/ (medical term: malignant neoplasm) is a class of diseases in which a group of cells display uncontrolled growth (division beyond the normal limits), invasion (intrusion on and destruction of adjacent tissues), and sometimes metastasis (spread to other locations in the body via lymph or blood). These three malignant properties. New, beneficial tests and treatments are expected as a result of the human genome project The Human Genome Project was an international scientific research project with a primary goal to determine the sequence of chemical base pairs which make up DNA and to identify and map the approximately 20,000–25,000 genes of the human genome from both a physical and functional standpoint. Many challenges remain, however, including the appearance of antibiotic resistance Antibiotic resistance is a specific type of drug resistance when a microorganism has the ability of withstanding the effects of antibiotics. Antibiotic resistance evolves via natural selection acting upon random mutation, but it can also be engineered by applying an evolutionary stress on a population. Once such a gene is generated, bacteria can and the obesity Obesity is a medical condition in which excess body fat has accumulated to the extent that it may have an adverse effect on health, leading to reduced life expectancy and/or increased health problems. Body mass index , a measurement which compares weight and height, defines people as overweight (pre-obese) when their BMI is between 25 kg/m2 and 30 epidemic.

Most of the research in the field is pursued by biomedical scientists A biomedical scientist , is a scientist educated in the field of biological science, especially in the context of medicine. Biomedicians are typically active in biomedical research in fields such as Anatomy, Pathology, Physiology, Pharmacology, Microbiology and traditionally tend to have more limited contact with patients. The recent trend is that in cooperation with molecular biologists Molecular biology is the study of biology at a molecular level. The field overlaps with other areas of biology and chemistry, particularly genetics and biochemistry. Molecular biology chiefly concerns itself with understanding the interactions between the various systems of a cell, including the interactions between DNA, RNA and protein.

Contents

Preclinical research

Preclinical research is research in basic science, which precedes the clinical trials, and is almost purely based on theory and animal experiments Animal testing / animal experimentation is the use of non-human animals in scientific experimentation. It is estimated that 50 to 100 million vertebrate animals worldwide — from zebrafish to non-human primates — are used annually. Although much larger numbers of invertebrates are used and the use of flies and worms as model organisms is very. Much of these experiments involve preclinical imaging modalities to aid in vivo, longitudinal studies.

New treatments come about as a result of other, earlier discoveries — often unconnected to each other, and in various fields. Sometimes the research is done for non-medical purposes, and only by accident contributes to the field of medicine (for example, the discovery of penicillin Penicillin is a group of antibiotics derived from Penicillium fungi. Penicillin antibiotics are historically significant because they are the first drugs that were effective against many previously serious diseases such as syphilis and Staphylococcus infections. Penicillins are still widely used today, though many types of bacteria are now). Clinicians use these discoveries to create a treatment regimen, which is then tested in clinical trials.

Clinical trials

Main article: Clinical trial Clinical Trials are conducted to allow safety and efficacy data to be collected for health interventions . These trials can take place only after satisfactory information has been gathered on the quality of the non-clinical safety, and Health Authority/Ethics Committee approval is granted in the country where the trial is taking place

A clinical trial is a comparison test of a medication A pharmaceutical drug, also referred to as medicine, medication or medicament, can be loosely defined as any chemical substance intended for use in the medical diagnosis, cure, treatment, or prevention of disease or other medical treatment, versus a placebo A placebo is a sham or simulated medical intervention that can produce a placebo effect. In medical research, placebos depend on the use of controlled and measured deception. Common placebos are inert tablets, sham surgery, and other procedures based on false information. In one common placebo procedure, a patient is given an inert pill, told that, other medications and devices, or the standard medical treatment for a patient's condition. Clinical trials vary greatly in size: from a single researcher in one hospital or clinic to an international multicenter trial A multicenter research trial is a clinical trial conducted at more than one medical center or clinic. Most large clinical trials, particularly Phase III trials, are conducted at several clinical research centers. The benefits of multicenter trials include a larger number of participants, different geographic locations, the possibility of inclusion with several hundred participating researchers on several continents. The number of patients tested can range from as few as a dozen to several thousands.

Every new drug formulation used in a clinical trial has to first undergo rigorous tests in a laboratory. Once the results from those tests confirm that the formulation is safe to be taken by humans, the drug is given to healthy volunteers in what are called Phase I clinical trials.[1]

Funding

Main article: Research funding Research funding is a term generally covering any funding for scientific research, in the areas of both "hard" science and technology and social science. The term often connotes funding obtained through a competitive process, in which potential research projects are evaluated and only the most promising receive funding. Such processes,

Research funding Research funding is a term generally covering any funding for scientific research, in the areas of both "hard" science and technology and social science. The term often connotes funding obtained through a competitive process, in which potential research projects are evaluated and only the most promising receive funding. Such processes, in many countries comes from research bodies which distribute money for equipment and salaries. In the UK The United Kingdom of Great Britain and Northern Ireland[note 7] is a sovereign state located off the northwestern coast of continental Europe. It is an island country, spanning an archipelago including Great Britain, the northeastern part of the island of Ireland, and many small islands. Northern Ireland is the only part of the UK with a land, funding bodies such as the Medical Research Council The Medical Research Council is a UK organisation dedicated to "improving human health through world-class medical research". It has produced 29 Nobel Prize winners and sustains an environment for internationally recognised research. The MRC focuses on making an impact and has provided the financial support and scientific expertise derive their assets from UK tax payers, and distribute this to institutions in a competitive manner.

In the United States, the most recent data from 2003[2] suggest that about 94 billion dollars were provided for biomedical research in the United States. The National Institutes of Health The National Institutes of Health is an agency of the United States Department of Health and Human Services and is the primary agency of the United States government responsible for biomedical and health-related research. It consists of 27 separate institutes and centers which includes the Office of the Director. Francis S. Collins is the current and pharmaceutical companies The pharmaceutical industry develops, produces, and markets drugs licensed for use as medications. Pharmaceutical companies can deal in generic and/or brand medications. They are subject to a variety of laws and regulations regarding the patenting, testing and marketing of drugs collectively contribute 26.4 billion dollars and 27.0 billion dollars, respectively, which constitute 28% and 29% of the total, respectively. Other significant contributors include biotechnology Biotechnology is a field of applied biology that involves the use of living things in engineering, technology, medicine, and other useful applications. Modern use similar term includes genetic engineering as well as cell- and tissue culture technologies. The concept encompasses a wide range of procedures for modifying living organisms according to companies (17.9 billion dollars, 19% of total), medical device A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery[citation needed]. If applied to the body, the effect of the medical device is primarily physical, in contrast to pharmaceutical drugs, which exert a biochemical effect. Specific regional definitions of medical device vary slightly as companies (9.2 billion dollars, 10% of total), other federal sources, and state and local governments. Foundations and charities, led by the Bill and Melinda Gates Foundation The Bill & Melinda Gates Foundation is the largest transparently operated private foundation in the world, founded by Bill and Melinda Gates. The foundation is "driven by the interests and passions of the Gates family". The primary aims of the foundation are, globally, to enhance healthcare and reduce extreme poverty, and in America,, contributed about 3% of the funding.

In Australia, medical research is funded mostly by the National Health and Medical Research Council The National Health and Medical Research Council is Australia's peak funding body for medical research, with a budget of nearly A$1bn a year[citation needed]. The Council was established to develop and maintain health standards and is responsible for implementing the National Health and Medical Research Council Act 1992 (NHMRC), whose expenditure on research was nearly $AUD700 million in 2008-09.[3]

The enactment of orphan drug An orphan drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease. The assignment of orphan status to a disease and to any drugs developed to treat it is a matter of public policy in many countries, and has resulted in medical breakthroughs legislation in some countries has increased funding available to develop drugs meant to treat rare conditions, resulting in breakthroughs that previously were uneconomical to pursue.

Regulations and guidelines

Medical research is highly regulated. National regulatory authorities oversee and monitor medical research, such as for the development of new drugs. In the USA ^ b. English is the de facto language of American government and the sole language spoken at home by 80% of Americans age five and older. Spanish is the second most commonly spoken language the Food and Drug Administration The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments, responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter oversees new drug development, in Europe the European Medicines Agency The European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products (see also EudraLex Categories: Clinical research | European Union law | Pharmaceuticals policy | ), and in Japan Japan is an island country in East Asia. Located in the Pacific Ocean, it lies to the east of the Sea of Japan, China, North Korea, South Korea and Russia, stretching from the Sea of Okhotsk in the north to the East China Sea and Taiwan in the south. The characters that make up Japan's name mean "sun-origin", which is why Japan is the Ministry of Health, Labour and Welfare (Japan) The Ministry of Health, Labour and Welfare is a cabinet level ministry of the Japanese government. It is commonly known as Kōrō-shō (厚労省) in Japan. This ministry provides regulations on maximum residue limits for agricultural chemicals in foods, basic food and drug regulations, standards for foods, food additives, etc. The World Medical Association The World Medical Association , an international organization of physicians, was formally established on September 17, 1947, pursuant to the resolutions of the First General Assembly of WMA held in Paris, France. In 2007, the WMA had a membership of 84 national medical associations and represents some 9 million physicians develops the ethical standards for the medical profession, involved in medical research. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical (ICH) works on the creation of rules and guidelines for the development of new medication, such as the guidelines for Good Clinical Practice Good Clinical Practice is an international quality standard that is provided by International Conference on Harmonisation , an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects (GCP). All ideas of regulation are based on a country's ethical standards code. This is why treatment of a particular disease in one country may not be allowed, but is in another.

Conflicts of interest

In 2001, the editors of 12 major journals issued a joint editorial, published in each journal, on the control over clinical trials exerted by sponsors, particularly targeting the use of contracts which allow sponsors to review the studies prior to publication and withhold publication. They strengthened editorial restrictions to counter the effect. The editorial noted that contract research organizations had, by 2000, received 60% of the grants from pharmaceutical companies in the U.S. Researchers may be restricted from contributing to the trial design, accessing the raw data, and interpreting the results.[4]

Fields of research

Fields of biomedical research include:

See also

References

Notes

  1. ^ The Importance of Clinical Trials in the Development of New Medicines
  2. ^ Moses H, Dorsey E, Matheson D, Thier S (2005). "Financial anatomy of biomedical research.". JAMA 294 (11): 1333–42. doi:10.1001/jama.294.11.1333. PMID 16174691.
  3. ^ NHMRC Annual Report 2008-09, 2009, http://www.nhmrc.gov.au/publications/synopses/nh126syn.htm
  4. ^ Davidoff F, DeAngelis CD, Drazen JM, et al (September 2001). "Sponsorship, authorship and accountability". CMAJ 165 (6): 786–8. PMID 11584570. PMC 81460. http://www.cmaj.ca/cgi/pmidlookup?view=long&pmid=11584570.

Bibliography

External links

Biomedical research: Study designs / Design of experiments
Overview

Clinical trial · Clinical trial protocol · Clinical trial management · Academic clinical trials · Study design

Controlled study (EBM I to II-1; A to B)

Randomized controlled trial (Blind experiment, Open-label trial)

Observational study (EBM II-2 to II-3; B to C)

Cross-sectional study vs. Longitudinal study, Ecological study Cohort study (Retrospective cohort study, Prospective cohort study) Case-control study (Nested case-control study) Case series · Case study / Case report

Epidemiology/ methods

occurrence: Incidence (Cumulative incidence) · Prevalence (Point prevalence, Period prevalence) association: absolute (Absolute risk reduction, Attributable risk, Attributable risk percent) · relative (Relative risk, Odds ratio, Hazard ratio) other: Virulence · Infectivity · Mortality rate · Morbidity · Case fatality · Specificity and sensitivity · Likelihood-ratios

Trial/test types

In vitro / In vivo · Animal testing · Animal testing on non-human primates · First-in-man study · Multicenter trial · Seeding trial · Vaccine trial

Analysis of clinical trials

Risk-benefit analysis

Interpretation of results

Selection bias · Correlation does not imply causation · Null result

Category · Glossary · List of topics

Categories: Medical research | Health research | Health sciences

 

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Is there a way that medical science can stop/reverse menopause? Why is there no research to stop menoause?
Q. Is it because the medical research community is dominated by men? I have read that there is sexism when it comes to research because more research is given to men's health issues as opposed to women's health issues. Actually it's seems pretty obvious to me because you would think in this day in age, menopause can be stopped.
Asked by icejan - Sun Jul 15 16:59:45 2007 - - 2 Answers - 0 Comments

A. Menopause is a natural process which should not be stopped. Beside, I don't see how you could stop it without awful side-effects. After a certain age, there is no need for menstruation, and childbirth becomes very dangerous for both mother and child. Believe it or not, the sole purpose of menstruation is so women can have children.
Answered by retzy - Sun Jul 15 17:20:20 2007

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