Importance Of Clinical Trials
What Are Clinical Trials
Clinical Trials:
Clinical trials are studies in medical science that involve people. The aim of these studies is to test whether different treatments prescribed on the basis of these tests are safe or not. These trials may involve either healthy members of the public or patients depending on the study. These are carried out to answer specific questions about the effect of a specific drug or treatment on health and illness of subjects.
Aims for conducting clinical studies :
1. Disease prevention and limiting the number of people with the illness.
2. If disease is incurable, at least improving the quality of life with illness may be the aim of some clinical studies.
3. Reducing the side effects of some treatments.
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The first proper trial was to test the use of streptomycin on pulmonary tuberculosis. It used fully randomised treatment and control groups. It was conducted by the Medical Research Council in 1948.
Since 1945, all kind of clinical trials is under strict ethical regulations.
Importance of clinical trials:
The best way to prevent and treat various health issues is to compare different approaches used and we can best compare them by clinical trials. To know what works best for any patient-physician need that kind of information. This is the only way to ensure the effectiveness of a specific treatment for any disease.
1. Clinical trials ensure at a very early stage the effectiveness of any treatment.
2. As these are carried out in different stages, if the results are not found satisfactory, we can quit development at the early stage.
3. Results of clinical trials can be used to make the decision about prescription or any drug or treatment by the physician to a particular patient.
Types of Clinical Trials:
Treatment trials: Most of the clinical trials performed are for studies that involve testing of new drugs or therapies on with disease.
Following questions may be asked for treatment
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These provide additional details about the safety and efficacy profile of the new drug. There are extensive studies on different formulations of new drug, various amount of dosages, the duration of treatment if it interacts with other drugs and safety profile. Trials can be conducted in patients with new age groups, different races, and various other types of patients.An important aspect of this phase of trials is the detection of previously unknown or inadequately quantified adverse reactions and various related risk factors. Sometimes experimental versus observational nature of experiments are distinguished from each other by use of the term post-market surveillance for the later.
References:
1. Van Spall HG, Toren A, Kiss A, Fowler RA (March 2007). "Eligibility criteria for randomized controlled trials published in high-impact general medical journals: a systematic sampling review". JAMA 297(11): 1233–40.
2. Glossary of Clinical Trial Terms, NIH Clinicaltrials.gov
3. Spilker, Bert. Guide to Clinical Trials, Raven Press, 1984. Page
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