What is Clinical Research?
Clinical research is the way physicians, scientists and pharmaceutical companies identify new and improved therapies for illness and disease. A clinical trial is a research study that answers a specific question or set of questions about a new therapy or way of using existing therapies. Top The Food and Drug Administration (FDA) requires that all new medications be thoroughly tested for safety and effectiveness before your doctor can prescribe them. New medications are carefully tested in the laboratory before clinical trials in humans are conducted. All treatments in widespread use today were first proven safe and effective in clinical trials. Research studies also investigate normal physiology and the changes in physiology that lead to disease. These help us understand why people develop symptoms and disease, and rarely do these studies involve the use of pharmaceuticals. By participating in clinical trials, volunteers help advance medical research and improve the quality of life of
Clinical Research is systematic study of new drugs, devices, biological products and vaccines intended for diagnosis, prevention or treatment of diseases. The aim of the study is to improve healthcare in the society by making safe and effective drugs available at low cost. The new drug development process involves drug discovery, animal experiments followed by studies conducted on human beings to assess the therapeutic effectiveness and toxicity by way of well designed experiments known as clinical trials. The word clinical refers to human beings. Clinical trials are conducted in three phases with increasing participation of human subjects at each subsequent stage. Clinical trials ensure safety and help to prove therapeutic efficacy of the new drug before the drug is available for prescription. Since drug trials involve human subjects, these are governed by scientific, medical, ethical, and legal guidelines to impart maximum safety and benefits to human subjects participating in the tr
The NIH Director’s Panel on Clinical Research (1997) developed the following description: • Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. This area of research includes: mechanisms of human disease; therapeutic interventions; clinical trials; development of new technologies • Epidemiologic and behavioral studies • Outcomes research and health services research. Note that this definition excludes in vitro studies utilizing human tissues that do not deal directly with patients. By contrast, “clinical trials” assess the safety & efficacy of new therapeutics, vaccines, devices, or other interventions. Clinical trials are divided into the following categories: Phase I (small numbers of healthy subjects to determine safety and appropriate dose); Phase II (larger numbers of subjects to gather preliminary eviden
Clinical research enables Doctors, Pharmaceutical Companies, Medical Device Companies and the East Coast Institute for Research (ECIR) to develop safer and more effective ways to understand, detect, control, and treat illness. The studies conducted by ECIR are pivotal in the development of new medicines and they help answer difficult scientific or health-related questions that benefit our society.
