Although there are many definitions for clinical trials, they are generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol. Carefully conducted clinical trials are the safest and fastest way to find treatments that work in people, and new ways to improve health. Many clinical trials are done to see if a new drug or device is safe and effective for people to use. These clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions.
In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. In Phase II trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety. In Phase III trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely. In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
Developing countries like India and Latin American countries are becoming ideal destinations to conduct clinical trials. There are many reasons for this. Mainly, flexibility of the government rules, availability of large pool of patients, trained physicians, low capital input and reduced study period. However, the clinical trials in developing and under developed nations are reported to misuse the patients. In several cases, patients were not informed what for they are used. And there are media reports that many patients have suffered a lot due to clinical trials and even many were died.
But using human for research is not a recent issue. Several controversial studies have contributed to the development of regulations to protect human research participants. Here I am giving very few examples for this from the web pages.
Nazi Government Research: During Second World War prisoners in concentration camps were used as subjects in Nazi experiments designed to advance the war effort. The studies involved battlefield medicine and chemical warfare experiments in which prisoners were tortured, usually to death. As a result of the methods used to conduct the experiments, the physicians involved were put on trial by the International Military Tribunal in Nuremberg, Germany from October 1945 to October 1946. Additional trials conducted by United States judges appointed by President Truman were held from December 1946 to August 1947. Fifteen of the 23 defendants were convicted and seven were executed for murder, torture and other atrocities.
Willowbrook Hepatitis Study (Mid 1950s to Early 1970s): The Willowbrook study involved infecting mentally retarded children with a Hepatitis virus to study the progression of the disease and to test vaccinations that were being developed at the time. Due to overcrowding, children were denied entrance to the Willowbrook State Mental Hospital unless parents enrolled their children into the less-crowded hepatitis ward.
Tuskegee Syphilis Study: In 1932, the Public Health Service of United States of America enrolled several hundred syphilitic black males to document the effects of the untreated disease over time. Tuskegee was chosen because approximately 40% of the male population of the town was infected with the disease. Treatment was withheld from study subjects when penicillin was accepted as the treatment for syphilis in 1943. This study was stopped in 1973 but not before many subjects became seriously ill, transmitted their disease to others or died. This study exemplifies unfair subject selection practices, denial of informed consent and excessive risk in relation to study benefits.
Milgram Study (1963): The Milgram study involved instructing subjects to administer electric shocks to a study confederate in response to poor performance. The subject believed that he/she was involved in a study about learning and memory with each shock intended to affect the learning process. The confederate pretended to be hurt by the shock - in some cases, to the point of losing consciousness; however, he/she did not really feel any shock. The study objective was to assess obedience to authority. This study resulted in significant psychological stress for some subjects including sweating, trembling, stuttering and serious seizures in three subjects. However, in a post-experimental interview, about half of the subjects expressed that they were glad to have participated in the experiment. The question of whether this study was ethical remains open to debate among scholars today.
US human radiation experiments (1944-74): Thousands of experiments took place during the cold war era in which humans were exposed to dangerous levels of radiation to test the effects of the atomic bomb, to gather safety data on the effects of the atomic bomb and to develop treatments for cancer patients. . In many cases, subjects provided informed consent prior to their participation, however this was not the case for subjects who were sick, imprisoned or otherwise vulnerable, including 54 mentally retarded children who were intentionally fed radioactive breakfast cereal. In 1993, an advisory committee to former President Clinton apologized for conducting these experiments.
M. Jayaprakashvel
Research Scholar
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