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By encouraging reporting of elements identified in the CONSORT statement in trial protocols (method of randomization, allocation concealment, blinding and attrition) trial design will be optimised during the planning of trials [ 38].
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We suggest further discussion and planning of trial design features such as the issue of combining RE and PS, placebo-control, active arms, blinding, outcome measures, logistics and so on, within a larger national or international multidisciplinary study group.
The FDA frequently offers input to sponsors during planning of early trials and late trials.
This may be achieved through giving greater consideration to TYA in the planning of clinical trials and ensuring that relevant trials are active in centres treating young people.
This evidence may be instrumental in the planning of definitive trials of a test.
The selection of a trial design is an important issue in the planning of clinical trials.
Effective planning of clinical trials requires an appropriate number of patients who fulfil given inclusion criteria.
The paper supplements earlier guidelines on the planning of vaccine trials against Plasmodium falciparum malaria [WHO.
We report on our perspective as researchers on the sensitisation activities undertaken for a phase II malaria vaccine trial in Kilifi District (Kenya) and Korogwe District (Tanzania), with the aim of informing and guiding the operational planning of future trials.
Therefore, planning of these trials should be made with caution.
Such information is needed for identification of study cohorts and planning of clinical trials of disease modifying OA drugs.
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