(a) (b) (c) Briefly outline what is meant by the Gillick (also known as the Fraser) principle with regard to consent. Give an example of the application of the Gillick (Fraser) principle with regard to a clinical trial of an investigational drug. From the study data in the table below from a trial involving a new oral contraceptive calculate the Absolute Risk Ration (ARR) and Relative Risk Ratio (RRR) for the new contraceptive compared to the control treatment.

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21.
Answer ALL parts of this question.
(a)
(b)
(c)
Briefly outline what is meant by the Gillick (also known as the Fraser)
principle with regard to consent.
B
(d)
Give an example of the application of the Gillick (Fraser) principle with
regard to a clinical trial of an investigational drug.
From the study data in the table below from a trial involving a new oral
contraceptive calculate the Absolute Risk Ration (ARR) and Relative
Risk Ratio (RRR) for the new contraceptive compared to the control
treatment.
Also calculate the Number Needed to Treat (NNT) to avoid one
pregnancy.
The outcome measure was a pregnancy occurring during treatment
Number of patients Number of pregnancies
Study Drug
Control Drug 7402
7328
48
63
If the p value for this difference was found to p- 0.01, what does this
mean?
Transcribed Image Text:21. Answer ALL parts of this question. (a) (b) (c) Briefly outline what is meant by the Gillick (also known as the Fraser) principle with regard to consent. B (d) Give an example of the application of the Gillick (Fraser) principle with regard to a clinical trial of an investigational drug. From the study data in the table below from a trial involving a new oral contraceptive calculate the Absolute Risk Ration (ARR) and Relative Risk Ratio (RRR) for the new contraceptive compared to the control treatment. Also calculate the Number Needed to Treat (NNT) to avoid one pregnancy. The outcome measure was a pregnancy occurring during treatment Number of patients Number of pregnancies Study Drug Control Drug 7402 7328 48 63 If the p value for this difference was found to p- 0.01, what does this mean?
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