Consider the following scenario:
An academic group have identified a small molecule inhibitor of the transcription factor nuclear factor kappa B (NFκB) which they have given the code name ABZ68. Realising that NFκB plays a critical role in regulating osteoclastic bone resorption, they perform a preclinical study in mice. They compare the effects of ABZ68 administered orally at a dose of 5mg/kg/day with those of alendronic acid (ALN) 10mg/kg/day and placebo in a mouse model of osteoporosis over a 6-week study period, studying 12 mice per group.
The results of the mouse experiment were analysed by Minitab using ANOVA and are summarised below. The ANOVA table shows the mean, standard deviation and 95% confidence intervals for the percentage change in BMD in the three groups over a six week study period:
Group N Mean StDev 95% CI
ABZ68 12 15.955 0.242 (15.7848, 16.120)
ALN 12 7.916 0.381 (7.748, 8.083)
Placebo 12 -1.010 0.201 (-1.1785, -0.843)
Pooled StDev = 0.285477
Your tasks are as follows:
Part I
Please review the results of the ANOVA. What is your interpretation of the study findings with regard to the effects of ABZ68 on bone density in mice as compared with placebo and how this compares with the effects of ALN. Please discuss how the findings of this study might impact on a decision to commence clinical studies.
Part II
The academic group who invented ABZ68 enter into a deal with a pharmaceutical company to progress commercial development with the aim of gaining marketing authorisation for the treatment of osteoporosis. You are hired as project manager and are tasked with authoring a report in which you describe the subsequent clinical trials that would need to be performed in order to assess the safety and efficacy of ABZ68 in humans. You are responsible for designing the subsequent studies that would be required to achieve this aim.
For each of the trial designs you select, please take the following factors into account:
• Justification of why you have chosen that design
• What the aim of the individual trial at each stage of the process would be
• What the sample size and duration of the study would be
• At which stage placebo or active comparators would be used
• What factors would be taken into account in choosing the dose at each stage
• Which endpoints would be studied at each stage.
The learning outcomes are:
1. Critically review the factors that contribute to the most appropriate study design for a research question including selection of endpoints, power, sample size, and presentation of results.
5. Conceptualise the principles of data analysis and presentation of trial results.
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