New Drugs In Clinical Trials

Some patients do not show desired response to established drugs. Continuous efforts for finding more effective and less harmful remedies are ongoing all over the world. This is especially true in case of inflammatory arthritis where new research has made many new effective drugs available and will keep on bringing in more and more new drugs.

Thousands of drugs are prepared in laboratories that work against the basic pathological process of a disease. This is fundamental research. One out of hundred drugs is then tested in animals. About 2-3 % of drugs effective in animal studies are then tested in human clinical trials. There are four phases in clinical trials. First phase involves testing for harmlessness of the drug and finding its appropriate dose in healthy volunteers. Some 200-300 patients are selected in the second phase and are administered either drug or placebo. Effectiveness, dose and adverse effects of the drug are studied in this phase. In the third phase hundreds of patients from many centers across the world are selected and studied over a prolonged period. New drug is required to be statistically more effective than placebo. Then and only then does the administration allows marketing of that particular drug. Thus just one or two drugs amongst 5-10 tested in clinical trials arrive in the market. This whole process takes 10-12 long years and involves expenditure of crores of Rupees. Fourth phase of clinical trials includes post-marketing surveillance. Restrictions are imposed on any drug that is found to have adverse effects that were previously unnoticed. Rofecoxib, a pain killer was thus banned and restrictions were imposed on use of Nimesulide.

No single new drug can enter the market unless this whole process of research is completed. New drugs are expensive due to the huge costs involved in drug research. Patent for a new drug expires after 20 years. Thus companies get just about 8-10 years to recover research and marketing costs. Other companies manufacture similar drug and compare with the parent drug over a much shorter period after expiry of the patent. These biosimilar drugs are much cheaper but may not necessarily be equally effective. But it is true that market competition brings down prices of these drugs in the benefit of patients.

Clinical research of global standards is being conducted at various places in India too. The patients who do not improve on currently available drugs may freely volunteer in such research as an alternative. The process of clinical drug trial starts with providing entire information about the drug and obtaining a audiovisual recorded consent from the patient. Patient consent is an essential prerequisite and no drug can ever be administered without such consent. Original treatment is not stopped even if patient denies consent. Any patient can withdraw consent without any explanation at any time during the trial if he or she feels uncomfortable due to any reason. The trial drug is provided free of cost. Carefully performed laboratory tests are also free of cost. Safety of patient is the basic condition for all clinical research. Local ethics committee or institutional review board too has utmost concern about patient safety. In case of any unfortunate event, whether related to drug or not, patients are fully compensated under insurance scheme. The legal language of consent document may sound very complicated due to international regulations. Patients need not worry about various adverse effects of drug mentioned in the consent document. If one tries to find a place by going by a route and does not find it, one tries to find another path to reach the place. So is the case of participation in clinical trials. The patients participating in the research are truly participating in progress of medical science. They help in providing new drug to patients. This charity is similar to that of a blood donor giving life to a patient.

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