[ExpertScie]

Clinical trials are set of test in drug development and medical research. These tests generate safety and efficacy data as required for developing confidence for safety of patients. These tests are done well before the product or new drug is brought in market. These trials give information about adverse drug reactions and other effects for health interventions. According to the results, evaluation of drugs, diagnostics, devices and therapy protocols are done. The approval of drug for bringing them in market is given by regulatory authorities of Government , example USFDA..

Initially pilot studies are done and depending upon the stage of its development, an investigator enrolls volunteers and other animals. After this, large group of patients and volunteers are covered to evaluate the drug under trial. Many a times, it is country specific but certain potential drugs are tested in various countries at a time. During trials, the investigator recruits patients with characteristics which are predetermined. After administration of treatments, the data is collected and analysis is done. Depending upon the results, conclusions are drawn. This conclusions and results are verified in detail by various regulatory authorities including Governmental departments.

The drug is effective in treating the disease but has side effects, in such cases; the drug is rejected and fails to pass clinical trials. This is because even though the patients get relief from disease, the later side effects are worse than it. Therefore for safety of patients, it is mandatory requirement to have lesser side effects. For example, if a drug is having clinical trials for treatment against cancer and is found to be effective in treating the deform, then it can just not be approved immediately. The patients under test are re-tested for side effects for a larger period of time for estimation or investigation of any later side effects. And if the latter side effects shows that with such drug which is under test, re-occurrences of cancer is observed, such drugs are rejected completed because it is at last of no use. This is the way of clinical trials to ensure patients safety first.

Also there are many cases , were in the side effects are not observed in first trial and even missed to identify it during later effect stage, but after approval of drugs if anything goes wrong with respect to safety of patients, after many years also, such drugs are banned by FDA or respective regulatory authorities of that country.

Below are some examples of best designs of what a clinical trial may need.
• Assess the safety and effectiveness of a new medication on patients who have been diagnosed with Alzheimer’s disease.
• Assess the safety and effectiveness of a different dose of a medication than eg. Instead of 5mg will be tested at 10mg.
• Assess the safety and effectiveness of an already marketed medication or device for a new finding, i.e. a disease for which the drug is earlier not approved.
• Assess and evaluate new device or drug with effective standard drugs. This is also known as Gold standard or the standard therapy.
• Compare the effectiveness in patients by comparing the already approved drugs and interventions for the diseases. For example if drug A is curing disease A then can new drug along with A drug can cure Large number of diseases or can treat broad spectrum of Gram Negative Organisms.
• Compare two or more number of medications at time. Comparing it with devices against each others.

Clinical trials are of different types , it depends upon its purpose. The US National Institutes of Health that is NIH organizes trials into five types.

The first one is known as Prevention trials, in this, the objective is to look for preventing diseases which were never in certain groups of people or patients. This includes minerals, vitamins, medicines and even changes in life styles. The second type is Screening trial this is the only way to detect certain disease or health conditions. The third type is Diagnostic trials this is for finding better test or methods for diagnosing a particular condition or disease. The fourth type is Treatment trial in this, new combination of drugs is tested and also new approaches to therapies are identified. The Quality of life trials are test which explores way to improve comfort or life quality for patients with chronic illness. The fifth is Compassionate use trials or expanded access trial. This is used to test unapproved therapeutics to a small number of patients and also to test completely the drugs which are earlier test partially.

The clinical trials are truly "safety shield for patients" against unknown new drugs!