This set of Drug Biotechnology Multiple Choice Questions & Answers (MCQs) focuses on “Controlled Release Medication – Clinical Trials – 1”.
1. Which of the following are not correct on the basis of clinical trials?
a) Biomedical research studies
b) Behavioral research studies
c) Studies on human subjects
d) Study based only on animals
View Answer
Explanation: Clinical trials are biomedical or behavioral research studies on human subjects that are designed to answer specific questions about biomedical or behavioral interventions such as novel vaccines, drugs, treatments, devices or new ways of using known interventions, generating safety and efficacy data. These trials are to test the safety and efficacy of a newly invented drug.
2. What are the different types of clinical trials according to the U.S. National Institutes of Health?
a) 6
b) 5
c) 4
d) 3
View Answer
Explanation: The U.S institutes of health organize trials into 6 different types and these are prevention trial, screening trial, diagnostic trial, treatment trial and quality of life trials. One way of classifying clinical trials is, by the way, the researchers behave that is an observational study and other is interventional study.
3. What do you mean by a randomized design?
a) The subjects do not know which study treatment they receive
b) Patients injected with placebo and active doses
c) Randomly assigning subjects either for placebo or active dose
d) Signed document of the recruited patient for the clinical trial procedures
View Answer
Explanation: Randomized design is when each study subject is randomly assigned to receive either the study treatment or a placebo. The subjects involved in the study do not know which study treatment they receive. If the study is double-blind, the researchers also do not know which treatment is being given to any given subject.
4. What is meant by a blind subject?
a) The subjects do not know which study treatment they receive
b) Patients injected with placebo and active doses
c) Fake treatment
d) Signed document of the recruited patient for the clinical trial procedures
View Answer
Explanation: The subjects involved in the study do not know which study treatment they receive. If the study is double-blind, the researchers also do not know which treatment is being given to any given subject. In this kind of study the subjects or the patients will not be knowing which study treatment they receive.
5. Which one of the following describes “double dummy”?
a) The subjects do not know which study treatment they receive
b) Patients injected with placebo and active doses
c) Fake treatment
d) Signed document of the recruited patient for the clinical trial procedures
View Answer
Explanation: A form of double-blind study called a “double-dummy” design allows additional insurance against bias or placebo effect. In this kind of study, all patients are given both placebo and active doses in alternating periods of time during the study. The use of a placebo (fake treatment) allows the researchers to isolate the effect of the study treatment.
6. What is placebo?
a) The subjects do not know which study treatment they receive
b) Patients injected with placebo and active doses
c) Fake treatment
d) Signed document of the recruited patient for the clinical trial procedures
View Answer
Explanation: The use of a placebo (fake treatment) allows the researchers to isolate the effect of the study treatment. It allows the researchers to see the effect on the patients or the healthy individual when they don’t get the drug rather they get a fake treatment. In this kind of study, all patients are given both placebo and active doses in alternating periods of time during the study.
7. What is informed consent in a clinical trial?
a) The subjects do not know which study treatment they receive
b) Patients injected with placebo and active doses
c) Fake treatment
d) Signed document of the recruited patient for the clinical trial procedures
View Answer
Explanation: An essential component of initiating a clinical trial is to recruit study subjects following procedures using a signed document called “informed consent.” Fake treatment or placebo allows the researchers to isolate the effect of the study treatment. Patient injected with active dose and placebo is also known as a double dummy.
8. Which one of the following is the last step of a clinical trial process?
a) Investigator selection
b) Patient recruitment
c) Statistical Analysis
d) Data filed and registration
View Answer
Explanation: The last step of the clinical trial is when the data are filed and registration from the FDA is obtained and the product is ready to be marketed. FDA approves the New Drug Application. Now the drug appears in the market and post-marketing studies, inspection starts.
9. Which one of the following will perfectly fit on the marked place?
a) Investigator selection
b) Patient recruitment
c) Statistical Analysis
d) Data filed and registration
View Answer
Explanation: This step involves checking the ratios, checking the number of patients who are showing which symptom, who are not so that they can have a proper count of how many patients may get benefited from the dosage. The statistical analysis is an important part which also involves dosage, age, patient details, study details etc.
10. Which one of the following will perfectly fit on the marked place?
a) Investigator selection
b) Patient recruitment
c) Statistical Analysis
d) Data filed and registration
View Answer
Explanation: After FDA has approved the IND the manufacturer company has to choose groups of patients and healthy people with their informed consent to start the procedure of the phase I trial. This the patient recruitment phase. Once the healthy individual for phase I trial are selected and the phase I trial is successful they have to again recruit for phase II trial.
11. Which one of the following will perfectly fit on the marked place?
a) Investigator selection
b) Patient recruitment
c) Statistical Analysis
d) Data filed and registration
View Answer
Explanation: After the laboratory studies are over the company submits IND and thus FDA if approves the IND will start the clinical trial phases. In this time the manufacturing company have to choose the Investigator who will investigate and keep a report of the whole process of phase I, II, III, IV.
12. How many people will be selected for phase I trial?
a) The whole market will be under surveillance
b) 300-3000 people
c) 20-300 people
d) 20-50 people
View Answer
Explanation: Phase I trials are the first stage of testing in human subjects. Normally, a small group of 20-50 healthy volunteers will be selected. This phase includes trials designed to assess the safety (pharmacovigilance), tolerability, pharmacokinetics, and pharmacodynamics of a drug. Phase 2 trial will be done on 20-300 people. Phase 3 trial will be done on 300-3000 people.
13. How many people will be selected for phase II trial?
a) The whole market will be under surveillance
b) 300-3000 people
c) 20-300 people
d) 20-50 people
View Answer
Explanation: Once the initial safety of the study drug has been confirmed in Phase I trials, Phase II trials are performed on larger groups 20-300 and are designed to assess how well the drug works, as well as to continue Phase I safety assessments in a larger group of volunteers and patients. Phase 1 trial will be done on 20-50 people. Phase 3 trial will be done on 300-3000 people. Phase 4 trial is post-marketing surveillance.
14. How many people will be selected for phase III trial?
a) The whole market will be under surveillance
b) 300-3000 people
c) 20-300 people
d) 20-50 people
View Answer
Explanation: Phase III studies are controlled tests on large patient groups 300–3,000 or more depending upon the disease and are aimed at being assessment of how effective the drug is, in comparison with current treatment method. Phase 1 trial will be done on 20-50 people. Phase 2 trial will be done on 20-300 people. Phase 4 trial is post-marketing surveillance.
15. Which one of the following will be checked under phase IV surveillance?
a) The whole market will be under surveillance
b) 300-3000 people
c) 20-300 people
d) 20-50 people
View Answer
Explanation: Phase IV trial is also known as Post Marketing Surveillance Trial. Phase IV trials involve safety surveillance (pharmacovigilance) and ongoing technical support of a drug after it receives permission to be sold. Phase 1 trial will be done on 20-50 people. Phase 2 trial will be done on 20-300 people. Phase 3 trial will be done on 300-3000 people.
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