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United States Department of Education in an evidence based meta-analysis of various studies conducted over a period of 12 years concluded that students who acquired higher education through online mode performed much better than those in regular class room courses. ( opepd/ppss/reports.html)

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What is Clinical Research & What are Clinical Trials?

What are Clinical Trials | What is Clinical Research | Clinical Research College

What are Clinical Trials | What is Clinical Research | Clinical Research College

Clinical research is a field of medical science that enables researchers to find out the safety and effectiveness of new medications, medical devices, products used for diagnostics and other treatment regimens, intended for use in humans. These may be used to prevent, cure, diagnose, or even to relieve symptoms of a disease. Clinical research is not similar to clinical practice. In clinical practice, doctors prescribe and follow established treatments which are already available in the market while in clinical research data is collected about the new medication, device etc to establish a treatment.

In clinical research, research is conducted either directly on a specific person or a group of people, or on materials from humans, such as their behavior or tissue samples, that can be linked to a particular living person. As per NIH, clinical research can be Patient-oriented research, Epidemiological and behavioral studies, or Outcomes and health services research.

Clinical trials are one type of clinical research. Clinical trials consist of a researcher or researchers, also known as investigators who directly observe a study subject or subjects, and/or who collect data to answer a scientific or medical question about the safety or potential benefit of an intervention such as a medication, device, teaching concept, training method, or behavioral change. The NIH defines a clinical trial as a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (such as drugs, treatments, devices, or new ways of using known drugs, treatments, or devices).

Clinical trials are conducted in four phases. Let us see what they are:

  • Phase I:

Phase I Clinical Trials are the first step in human testing and they enable researchers to find out the safety of a drug in a small number of healthy volunteers (usually 20-80). These trials provide data about whether the new drug is tolerated by the human body and if behaves in the predicted way.

  • Phase II:

Phase II Clinical Trials enable researchers is to further determine the safety and side effects of the new drug. The optimal dosage of the new drug for use in humans is also determined in this phase. Opposed to Phase I in which the new drug is usually tested in healthy volunteers only, in Phase II the drug is tested in people suffering from the targeted disease. The number of patients enrolled in this phase are usually about 100 - 300.

  • Phase III:

Phase III Clinical Trials are the final phase before the drug can hit the market. This phase carefully examines the effects of the new treatment on survival, prevention of disease recurrence, efficacy or similar "end points" in a significantly large number of patients (1000 - 5000). The approval of a new drug from licencing authorities such as the FDA and EMEA usually requires one or more successful phase III trials.

  • Phase IV:

Phase IV Clinical Trials are conducted after the new drug is approved for marketing and is available to doctors for prescribing to their patients. The main aim of Phase IV trials is to continue monitoring the effects of the drug in thousands of patients to help identify any new side effects.

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