(a) Discuss the THIRTEEN (13) principles of SGGCP.
(b) Name the different parties involved in CT and comment on the responsibilities of each party.
(c) Suggest the different types or design of study based on the following field of clinical research covered in:
Discuss the RCT study design.
Read the two case studies given below and answer the questions accordingly.
Case Study 1 (30 marks)
A study is being planned to compare a new vaccine to the currently available vaccine, for children, consisting of five components in a single dose. The study is being sponsored by a private pharmaceutical company. At present, children in this country receive a vaccine with three components in a single dose, and two additional components in a separate dose, all given during the same visit. The study group will be boys and girls, 15 months old, who would go to the country’s Health Units for the current vaccination regimen.
The plan is to enrol 300 children in three months. After parental informed consent, children will be randomized to receive the current vaccination regimen or the new, one-dose regimen. The investigation would be conducted in five Health Units of the Ministry of
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BME215e ￼ Tutor-Marked Assignment
Health, where the application of the current vaccination regimen is mandatory and free of charge. The Ministry of Health has given approval to conduct the study.
The main endpoints are:
• Adverse experiences or reactions to the vaccine.
• Antibodies produced in response to the vaccines.
For this purpose, the children will have to provide a blood sample at the time of the injection and one month after. Blood samples will be taken at each clinic, be sent to a central laboratory, and then sent out of country for antibody analysis. Private paediatricians will be contracted as investigators to reinforce the paediatricians of the Health Units. In case of adverse events, participants would be referred to the government’s Children’s Hospital.
• The parents of children seeking care in the Health Units are typically poor economically.
• Many of the parents do not read and write and have little formal education.
• Children often come to the Health Units with individuals other than their parents, who are
(a) Discuss if the sponsor of the study should provide the Ministry of Health with the control treatment (currently used vaccine) on top of the new vaccine for the study. Justify your answer.
(b) Analyze why the study should be conducted only in the Health Units and not in private clinics.
(c) In your opinion, is the enrolment plan which is to be conducted in busy Health Units realistic? Discuss your answers.
(d) Suggest steps which the researchers can take to ensure that the individuals accompanying the children have legal responsibility for the child. What should researchers do in cases where legal responsibility is uncertain?
(e) Discuss the assurance that can be given to the parents so that they will allow blood to be taken from their child and that they will return the child to the clinic for follow-up blood sampling or adverse events.
(f) How would the researchers ensure the control of the blood samples during transport to the central laboratory and out of the country?
(g) In cases of adverse events, discuss if these cases should be referred to the Ministry of Health hospital or a private hospital.
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BME215e ￼ Tutor-Marked Assignment
Case Study 2 (30 marks):
To test a human vaccine against malaria caused by Plasmodium vivax, a research group submits a three-phase protocol to the Research Ethics Committee (REC) of the local university. Differing from other protocols, a “challenge” methodology is proposed; where resea
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