Biomedical research

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]


Biomedical research (or experimental medicine), in general simply known as medical research, is the basic research or applied research conducted to aid the body of knowledge in the field of medicine. 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, and all other research that contributes to the development of new treatments. The latter is termed preclinical research if its goal is specifically to elaborate knowledge for the development of new therapeutic strategies.

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 for measles and polio, insulin treatment for diabetes, classes of antibiotics for treating a host of maladies, medication for high blood pressure, improved treaments for AIDS, statins and other treatments for atherosclerosis, new surgical techniques such as microsurgery, and increasingly successful treatments for cancer. New, beneficial tests and treatments are expected as a result of the human genome project. Many challenges remain, however, including the appearance of antibiotic resistance and the obesity epidemic.

Most of the research in the field is pursued by Biomedical Doctors/Scientists in cooperation with Molecular biologists.

Preclinical research

Preclinical research precedes the clinical trials, and is almost purely based on theory and animal experiments.

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). Clinicians use these discoveries to create a treatment regimen, which is then tested in clinical trials.

Clinical trials

These refer to any form of previously untested treatment for a particular pathology. This can take the form of a new surgical procedure, a new drug, or a new treatment regimen. These are extensively tested in clinical trials prior to widespread use.

If these trials have been well designed and are successfully duplicated by independent laboratories or field trials, then the papers can be reviewed by an independent body such as the Cochrane Collaboration to serve as an authoritative source of clinical guidance.

Criticism of clinical trials

Many clinical research trials published are performed or sponsored by companies who have developed the drug or medical device being tested.[1] Published studies, funded by companies with a financial incentive contingent on the result of the study, are more likely to show significant results than the results of studies funded by disinterested parties.[2] The results from these corporate-sponsored trials are often subsequently used in direct to consumer sales and marketing campaigns, which may influence the use of the treatment or drug in a clinical setting, based solely on patient demand for treatments that they believe are effective.[3]

Bias in results can also occur when researchers involved in a clinical trial want to gain prestige, or believe that positive results obtained by a trial further a scientific hypothesis that they support.[4]

Many companies work with recognised medical bodies to offer paid clinical trials. In 2006, a failed test in London caused multiple organ failure in six people.[5] In response, British scientists defended the testing as one of the best regulated in the world.[6]

Funding

Research funding in many countries comes from research bodies which distribute cash for equipment and salaries. In the UK, funding bodies such as the Medical Research Council and the Wellcome Trust 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[7] suggest that about 94 billion dollars were provided for biomedical research in the United States. The National Institutes of Health and pharmaceutical companies 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 companies (17.9 billion dollars, 19% of total), medical device 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, contributed about 3% of the funding.

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 the Food and Drug Administration oversees new drug development, in Europe the European Medicines Agency (see also EudraLex), and in Japan the Ministry of Health, Labour and Welfare (Japan). The World Medical Association 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 (ICH) works on the creation of rules and guidelines for the development of new medication, such as the guidelines for Good Clinical Practice (GCP).

See also

References

  1. Adams C, Rathbone J, Thornley B, Clarke M, Borrill J, Wahlbeck K, Awad A. "Chlorpromazine for schizophrenia: a Cochrane systematic review of 50 years of randomised controlled trials". BMC Med. 3: 15. PMID 16229742.
  2. Als-Nielsen B, Chen W, Gluud C, Kjaergard L (2003). "Association of funding and conclusions in randomized drug trials: a reflection of treatment effect or adverse events?". JAMA. 290 (7): 921–8. PMID 12928469.
  3. Vitry, Agnes (2004;27:4-6). "Is Australia free from direct-to-customer advertising". Australian Prescriber. Retrieved 2006-10-05. Check date values in: |date= (help)
  4. Ioannidis J (2005). "Why most published research findings are false". PLoS Med. 2 (8): e124. PMID 16060722.
  5. Six taken ill after drug trials
  6. Scientist defends clinical trials
  7. Moses H, Dorsey E, Matheson D, Thier S (2005). "Financial anatomy of biomedical research". JAMA. 294 (11): 1333–42. PMID 16174691.

Further reading

  • Indrayan A (2004). "Elements of medical research". Indian J Med Res. 119 (3): 93–100. PMID 15115159.
  • Highleyman L (2006). "A guide to clinical trials. Part II: interpreting medical research". BETA. 18 (2): 41–7. PMID 16610119.Full text
  • Beyleveld D & Pattinson S D (2006). "Medical Research into Emergency Treatment: Regulatory Tensions in England and Wales". Web JCLI. 5. full text




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