Clinical Trials, Pharmacogenomics, and the FDA - Essay Example

Clinical Trials, Pharmacogenomics and the FDA What is a clinical trial? Why do we do them? [Hint: is it simply to show “safety and efficacy” or perhaps something more?]. Clinical trials is a method of clinical research, in which the researcher or researchers who directly observe a person or people, and/or who collect data to answer a scientific or medical question about the safety or benefit of an invention. The invention could be a medicine, a toll, teaching concept, training method, or behavioral change. Clinical trials are done to determine whether the new biomedical or behavioral interventions are safe and effective, whether the human subject invention like the diet, physical activity meets its definition. The trial is also been carried out on human subjects to evaluate the clinical laboratory tests. Clinical trials are more than efficacy and safety; they are designed to provide information about different types of outcomes of the invention. Studies relating to pharmaceutical product are carried out in clinical trials to reveal what does the product does to the body. Pharmacokinetics studies are also done to determine the proper dosing, which can vary according to race, sex and metabolic differences. Pharmacodynamic studies are also used to examine the ability, safety and the clinical activity of the drug or device. Thus, clinical trials are significant, since it examines the interventions in details before it hits the market to common man. 2. Why do we call a clinical trial a clinical trial? In other words, is not a clinical trial really an experiment?? If so, then why do we not call them clinical experiments?? When the drug or any intervention is set for clinical trial, the experimentation stages are over. All the data regarding the invention are already been recorded, when it is set for clinical trial, it is to determine whether it can be utilized by humans or not. For example in case of any drug, the experiments relating to its origin, purification, its release etc, are already over when it hits the clinical trial. The study is also been carried in humans to determine the dosage, its side effects, after-effects etc. The safety and the effectiveness of the medication or device on a specific kind of patients are assessed. It is also assessed whether the new medication or device is more effective for the patient`s condition than the already used, standard medication or device. Thus, a clinical trail is not a set of experiments; it a set of both observational and interventional study. 3. What does safety really mean? [Hint: airplanes are relatively safe but every once in a while, an air plane will fall out of the sky. Does that mean we should ban airplane travel?? How is the safety of air travel any different than the safety of Vioxx or the safety of the drug-eluting stent?]. Drug safety has many implications on its use. In general practice drug has to undergo various validation processes before commercialization and this entire processes heads under name of clinical trials. During clinical trials the effectiveness and toxicity of drug is monitored with different group of people in limited time interval. Due to many constraint in term of cost, sample size and time duration many side effects of new drug does not come up during trial, but long term side effects or toxicity will seen at longer time duration after commercialization .Hence the constant monitoring and data mining is needed to evaluate new drug. This monitoring come under Drug safety portfolio, which includes proper labeling having detail of side effect dose and other detail, Publication of update regarding any incident showing side effect, centralize data base having accesses of various health professionals etc. The major difference between drug safety and other safety is time line and end use. For example drug which are used in chemotherapy having inherent risk or side effects but still it use for treatment as benefit of that treatment is more than damage caused by it. Similarly some drugs are not suitable for particular patient but can be used safely for others. In short, safety of drug depends on many parameters including its end use, people having side effects, and statistically significant data, while other safety depends only on probability of failure. 4. What does efficacy mean? [Hint: efficacy does not mean whether or not the product “works” – that is much to simple!]. A drugs effects can be evaluated in terms of strength (potency) or effectiveness (efficacy). Potency is an indicator of concentration requirement to exert definite effect. In other word if drug A shows its effect at 5mg concentration while Drug B shows similar effect at concentration of 7mg than drug A is more potent than drug B. While Efficacy refers to the potential maximum therapeutic response that a drug can produce. Here the comparison of drug is carried out based on the final effect of two drugs administered in equal concentration. For example drug A and B are two drugs having effect on kidney functioning in terms of water removal from the body. If Drug A induces more filtration than Drug B, than efficacy of drug A is more than drug B. However, greater potency or efficacy does not necessarily mean that one drug is preferable to another. Before prescribing any drug doctor considers many parameters like side effects, potential toxicity, duration of effect, past history of patient and cost. 5. What is the job of the FDA? Some would argue that if sponsors (i.e., manufacturers) did their jobs correctly, we would not need an FDA. How would you respond? The job of FDA is regulation of safety types many types of foods, dietary supplements, biological medical products, radiation emitting devices, drugs, vaccines, blood products, vetenary products and cosmetics in United States. Yes, ne can argue on that poin that if manufactures did their job correctly there would be no need of FDA. But than there has to be some agency that keeps a check all the food products and other dietary supplements on one scale. FDA not only checks the safety of the drug bit it checks the safety of the drug relatively to the other drugs in the market. In my viewpoint FDA should exist since, sometimes manufacturers after spending investing so much in products, might would want to overlook its side effect which may or may not be minor one, but for the mass it does matters! 6. What is pharmacogenomics? How might pharmacogenomics change how we do clinical trials in the future? Pharmacogenomics is the branch of pharmacology which examines the influence of genetic variation on drug response in patients. Here researcher tries to get answer of why some patient shows more efficacy and less toxicity for particular drug but not with other? In conclusion by understanding effect of genetic make up on drug response one can come up with personalize drug therapy which varies from patient to patient. The main objective of pharmacogenomics is to minimize side effect with enhance efficacy. Completion of Human genome project and development of high density SNP database will change the concept of clinical trials. In past clinical trials has to be performed at different location and with different group of people to understand its efficacy and toxicity but now based on genomic data one can predict drug performance on different group of people having different genetic make up. Similarly now drug can be deigned for specific ethic group or for group of people having similar genetic makeup which reduced the trial time and cost. Read More