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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.

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 Subject :Historical Events in Clinical Research: Part II.. 2009-10-31 21:43:34 
Sathvika
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  • 1760: Anton Storck of Vienna tests the effect of hemlock in increasing doses on himself.
  • 1764: Thomas Bayes of England publishes Baye’s Theorem for calculating conditional probabilities, establishing the statistical basis for adaptive trials.
  • 1767: English court rules in Slater v. Baker & Stapleton that informed consent is required prior to experimental medical treatment. Baker and Stapleton set and then rebroke Slater’s fractured but healing leg to test a new device.
  • 1767: Prior to inoculating all the children at the Foundling Hospital in London, England for smallpox, Dr. William Watson conducts a vaccination trial with three groups of 10 children each. Two of the groups receive pre-and post-treatments; one does not.
  • 1775: British physician William Withering identifies leaves from the foxglove plant as an ingredient in herbal remedies for dropsy (the accumulation of fluid in the lower extremities due to cardiac insufficiency). He later proves its effectiveness in experiments on numerous patients. The active ingredient is digoxin, a current treatment for congestive heart failure.
  • 1784: Under appointment by Louis XVI of France, a commission led by Benjamin Franklin conducts placebo-controlled and single-blinded (literally, by blindfolding the subjects) studies of the use of magnetism to treat various ailments.
  • 1796: Edward Jenner of England demonstrates that cowpox vaccination protects against smallpox by vaccinating and then exposing 12-year-old James Phipps to someone with smallpox.
  • 1796: First patent on a medical device is issued, for Perkins Metallic Tractors, consisting of two pointed metal rods about three inches long, one iron and one brass, used as levers to draw toxic electricity from the body in the treatment of headache, rheumatism, deformities, etc.
  • 1799: John Haygarth conducts placebo-controlled and single-blinded (with sham wooden “medical devices”) studies of the use of Perkins Metallic Tractors, consisting of iron and brass rods, to relieve pain.
  • 1800: Benjamin Waterhouse, one of three full-time professors at Harvard Medical School, successfully tests Edward Jenner’s cowpox vaccine on his son, then on six members of his household, and then on 19 children in a Boston hospital. He then creates a commercial monopoly on the vaccine in the United States. Partially as a result, he is expelled from the Harvard faculty in 1812.
  • 1803: Thomas Percival of England publishes “Code of Ethics”, advising physicians to consult with colleagues before trying new remedies and treatments. Percival separately advises physicians not to inform the patient if the information would adversely affect the patient, the patient’s family, or the community.
  • 1809: Scottish physician Alexander Lesassier Hamilton and two other army physicians conduct a clinical trial in which 366 sequentially-admitted sick soldiers are assigned in rotation to three physicians. One physician uses bloodletting; the other two do not. Mortality rate is 29% with bloodletting and 2% without
  • 1813: Vaccine Act regulates vaccines.
  • 1818: Scottish physician Alexander MacLean, describes medicine practiced without systematic testing as,"a continued series of experiments upon the lives of our fellow creatures."
  • 1820: Eleven physicians meet in Washington D.C. to create the U.S. Pharmacopeia, a compendium of standard drugs.
  • 1824: Royal Society for the Prevention of Cruelty to Animals is founded in London.
  • 1830: English physician J.W. Willcock writes: “When an experiment is performed with the consent of the party subjected to it after he has been informed that it is an experiment, the practitioner is answerable neither in damages nor on an original proceeding. But if the practitioner performs his experiment without giving such information and obtaining consent he is liable to compensate in damages any injury.”
  • 1831: English physiologist Marshall Hall proposes principles to govern animal experimentation.
  • 1832: "Placebo" takes on its current meaning of a treatment that has no medical value except psychologically.
  • 1832: Physician William Beaumont signs a contract with Alexis St. Martin, a long-term research subject with a permanent gastric fistula (hole to his stomach), whereby Mr. Martin enlists in the Army for one-year – with no military duties – and receives payment of $150.

 

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