Question

You are in a pharmacogenetics Ph.D. program and have developed a new drug to treat diabetes, which has gone through its first clinical trial. The results of the clinical trial are not conclusive, but you notice that some people did very well on the drug and others suffer serious side effects. With the current results, the FDA will not approve the drug for use with patients. You still have hope that the drug will be effective, but need to do more work to achieve this outcome and complete your Ph.D. degree.

1. What pharmacogenetics research approach would you take to further the potential application of this drug and why would you take this approach?

2. What results would you anticipate if your research approach were to be successful and how would you interpret these results?

3. If your results were successful, how would you choose the patients for the next clinical trial?

Answer 1

1. reaearcher can use experimental methods mainly randomized design after the pilot study. Because pilot study is used for getting permission and for assessing feasibility of new drug and helps to prevent false results. Experimental is being used for testing the drugs in the pharmacology. An experimental method provides detail of cause and effect relationship. This diabetic new drug can be used for the patients with diabetic and follow the patient’s reaction over the periods and then patient begin to show the result of effect of the drug over the period. It may be short term effects and long term effects. the sideeffects may be due to false selection of the patients based on age,gender, eduaction, duration of illness, occupation, type of illness.

2. In experimental method, pretest and post test should be done in order to assess the effectiveness of medicine. Pretest such as all the blood investigation in addition to blood glucose to be done for both experimental and control group and after giving medication to only experimental group in order to assess effectiveness of medication on level of  blood glucose and post test to be done and assess for its side effects in experimental group and normal post test in control group. If the research is successful, the results are presented in a way there is a significant difference exists between pretest and post test blood glucose among the experimental group and control group after using new drug. The results are interpreted like there is a significant difference between control group and experimental group after administration of new drug

3. the selection is based on these requirements. because it provides good results.

1.separate a group because there is higher and lesser chance of identifying difference before and after treatment

2.identify homogenous group in order to assess the effectiveness of the treatment and thereby bias canbe avoided and results become more sensitive

3. obtain the sample from affected people and then form a guidlines and people whol follow ethical considerations

the patients should be accessibel and target people and meets criteria of research

The patient should be selected on the basis of age, sex, height, weight, occupation, education, body mass index, duration of illness, types of diabetes mellitus. Age is important factor that affect the level of the blood glucose. Because the level of blood control and complication of blood glucose increases in advanced age. Gender also affect the effectiveness of the drug. Because effects of diabetes mellitus sis more in females than males. Body proportion also affects use of drugs, occupation is important, because effect of physical activity also affect on use of drugs. Education also important. Because they able to tell understand and tell side effects of medication. types of diabetes mellitus may be acquired or hereditary one. duration of illlness also afffects effectiveness of medication.