4.1: Describe the impact of using inclusion and exclusion criteria on the validi

Question

4.1: Describe the impact of using inclusion and exclusion criteria on the validity of a clinical trial.

4.2: Discuss ways to minimize attrition bias in clinical trials.

4.3: Briefly outline an optimal study that could be conducted to evaluate the effect of Drug X on Alzheimer’s disease progression and justify your choice of design, blinding, internal/external validation, and outcome measures.

4.4: Compare and contrast factorial, sequential, crossover, and adaptive designs in clinical trials.

4.5: Suppose that among 100,000 women with negative mammograms, 20 will have Breast Cancer (BC) diagnosed within 2 years; and among 100 women with positive mammograms, 10 will have BC diagnosed within 2 years.

a. What is the Relative Risk (RR)?

b. What is the Risk Difference (RD)?

c. Restate your conclusion(s) in the form of a sentence.

Explanation / Answer

4.1)Inclusion criteria is the factors that allows to take part in a study ( age, gender and type of condition)and exclusion criteria are the factors or subjects which has to excluded in a study.They help to take specific decision which helps in analysis and interpretation of a study.

4.2)To prevent attrion bias:

1) Include more participants than the required participants to compensate the withdrawals.

2)Use last obtained data from a lost participant as the end point data, basically assuming that that the data given is close to the previous datas.

4.3 Randomized controlled trial is the choice of study where we have two groups of people having same condition. One can be given drug X and the other placebo.Then the results can be compared. The effects can be externally validated.

4.4.Factorial trial: it refers to the effect of a two intervention studied alone or combined.

Sequential trial: It is the combination of all the information of the trials.

Crossover trial: Where each subject receives different kind of treatment and the effect is studied.

Adaptive design: Where changes can be made to the trial or statistical procedure of an ongoing study.

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