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Our trial design was unusual, as not all patients with suspected HIT could be expected to reach the primary endpoint.
Although we modeled our trial design on real trials, we made simplifying assumptions, which may not accurately reflect reality.
Our trial design was based on the results of these studies not allowing a 'surgery-only' arm.
Our trial design allowed us to distinguish the effect of offering a new test, that is, HPV instead of Pap, and the effect of self-sampling.
We chose to include LAD, because our trial design was a feasibility phase II study, and not a phase III survival trial.
We also proved the feasibility of our trial design, which can be used for larger trials provided that funding can be raised.
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To optimize our trial designs, we adopted two strategies to measure mdx phenotypes at points of increased severity, in one trial by assaying young mice during natural peaks in disease severity, and in the other by using forced exercise protocols in adult mice to exacerbate disease.
A limitation for generalizing the study results may result from our particular trial design and target group.
Our prospective trial design permitted the assessment of sVARI on clinical outcomes independent of biases introduced by retrospective chart review.
The ultimate goal of our clinical trial design is illustrated in Figure 2 and currently consists of two separate but interconnected therapeutic oestrogen studies, designed to determine the lowest dose of a 12-week course of oestrogen that causes a positive therapeutic effect.
As well as seeking to develop a novel and adaptable intervention that engages schools, children and their families, we sought to determine whether our proposed trial design and outcome measurements are feasible and acceptable for schools as well as individual children and their families.
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