Clinical research is a highly organized and comprehensive study that investigates innovative methods for preventing, detecting, diagnosing, or treating various types of diseases and medical conditions. Some consider clinical research as the pillar of medical science, even in the ancient times. Clinical research has paved the way to inventions and contributions in the medical field that led to saving the lives of billions of people.
The output of clinical research is used to test new methods of treatment, therapies and medicines or drugs with human beings as subjects. With modern medicine, however, these clinical trials and investigations are performed by following protocols that adhere to the standards of patient care, safety, and data interpretation.
World War II
The horror of World War II revealed that researches on prisoners in concentration camps were done on involuntary participants who died as a result of the experiments. After the WWII, many doctors were tried for their crimes in the Nuremberg, Germany. Because of this, the 1948 Nuremberg Code was created — stating that voluntary consent must be mandatory for any clinical research. This means that volunteers need to give their consent to be a subject of the study and that they are not to be coerced to do the study and that they understand the risks and benefits involved in the undertaking. In 1948, the Nuremberg Code was adopted in the United Nations.
Postwar Research Abuses Continued
Even after the Nuremberg Code, more unethical and abusive clinical researches persisted in the US and UK. The reason was that many researchers believed that the Nuremberg Code was applicable only to the Nazis and did not have the force of law in the US and other countries except Germany. So this kind of mindset resulted in more abuses.
Henry K. Beecher published a highly influential article entitled “Ethics and Clinical Research” in the New England Journal of Medicine. In his book, he listed not less than twenty cases of highly unethical research practices wherein the lives of the patients were risked. He cited one study in an institution for mentally retarded patients in New York who were fed live hepatitis virus. He also cited another case at Brooklyn Jewish Chronic Disease hospital in which senile patients were injected live cancer cells to find out the immunological responses.
Developments in Clinical Research
The earliest record of clinical research dates back to the ancient era of Nebuchadnezzar II, which dealt with diet and water.
In 1537, a Renaissance surgeon by the name of Ambroise Pare unintentionally improvised a soothing balm made from egg yolks, rose oil, and turpentine. It was an accidental discovery because he just improvised the soothing oil when he ran out of “cauterizing oil” that they used for pain relief. His experiments and writing was the foundation of empiricism in European medicine.
Clinical researches and trials proliferated and gained the attention of medical practitioners worldwide. The results of the studies were considered and assessed for their significance in medicine. In 1863, clinical trials used for the very first time placebos in their studies. Randomization, as a research concept, evolved in 1923. The first research using randomization treatment options with control groups was done in 1948 by a Medical Research Council team involving various streptomycin treatment of pulmonary tuberculosis. The research also made use of blind assessment resulting to an unbiased analysis and unadulterated result.
In 1954, the clinical trial of Salk polio vaccine was the largest clinical research and trial.
Many advancements in medical researches came after the WWII. The revelations of unethical research practices paved the way to the creation of ethical guidelines to protect human subjects.
The Helsinki Declaration
The World Medical Association developed in 1964 to govern all medical research and trials stipulating the detailed standard for human experimentation. In the declaration, guidelines are given for medical doctors doing biomedical researches with humans as their subjects. Included in the guidelines are the research protocols by an independent committee before the start of the research project. It also indicated that researches with humans will only be conducted based on results from laboratory animals and experiments.
Kefauver-Harris Drug Amendment
The Kefauver-Harris Drug Amendment is the basis for changes to the Federal Food Drug & Consumer Act. The amendment requires drug companies to prove both safety and effectiveness of their products. This is the same amendment that requires drugs to have FDA approval before they are marketed to the public. This regulation was a result of the thalidomide incident in 1950 in Western Europe where the sedative drug, thalidomide was inaccurately marketed to pregnant women as sleeping pills resulting to over 12,000 deformed newborn babies.
National Research Act
After the revelation of the Tuskegee Syphilis Experiment, the National Research Act was passed in 1974. What is the Tuskegee Syphilis Experiment? The study started in 1932 until 1972. The aim of the research study was to examine the long term effects of syphilis. Four hundred African Americans were the subjects of the study who were poor sharecroppers. They had syphilis but were not aware of it. They were also unaware that they were subjects of a medical research. In 1950’s, penicillin was discovered to be effective cure for syphilis. The horrifying thing was, these men were not given treatment and other doctors were also prevented to give treatment for syphilis to these subjects. More than one hundred men may have died from syphilis complications when the disease is not treated. In 1972, the world was shocked when a researcher who worked on the project revealed this horror. As a result, the project had to be shut down. In 1997, President Clinton apologized to the victims of the Tuskegee study.
The National Research Act led to the creation of the National Commission for the Protection of Human Subjects in biomedical and Behavioral research. The Commission was tasked to create a solid set of guidelines for conducting ethical research without losing human rights. They drafted the Belmont Report setting the boundary between research and routine practice. They also defined informed consent to ensure that participants were kept informed during the experiment. The role of risk-benefit analysis was also determined to make sure that participants fully understand the risks and the benefits of the clinical trials. The Belmont Report also emphasized guidelines for participation especially for individuals with lower capacity for decision-making. Children, the elderly and the developmentally disabled needed the same protection and rights. Every clinical research and clinical trial have to follow standard practices that focus on the safety of the patients or subjects and requiring informed consents from all participants.
The report succeeded in establishing three important tenets of ethical research – respect for humans, beneficence and justice.
The same report was the basis for revising research rules in the US Departments of Health and Human Services and the FDA.