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MR and EH contributed to the design of the trial, the development of questionnaires and to the manuscript; HK and SLH contributed to the development of questionnaires and to the manuscript; KF contributed to the data analysis and to the manuscript; PV contributed to the development of questionnaires, data collection and analysis, and to writing the manuscript.
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Owing to the perceived need for a succinct instrument to evaluate HRQOL in HIV-infected patients in multi-center AIDS clinical trials, the development of the MOS-HIV was begun in 1987 [ 14].
Finally, given the fact the respiratory domain was not a significant predictor of EQ-5D utility, and the emphasis on respiratory symptoms in CF trials, the development of a disease specific preference based measure may also be worth further investigation.
Because adverse events may not occur in the short time periods used in drug trials, the development of registries of patients treated with DMARDs may be necessary to accurately assess both risks and benefits [ 35].
In randomized clinical trials, the development of new positive antinuclear antibodies (ANA, titer ≥ 1 40) was noted in a greater percentage of patients treated with etanercept than with placebo (11% versus 5%) [ 3].
23 In order to carry out these trials, the development of a validated assay to detect GR expression will be needed to identify patients who are most likely to benefit from treatment.
Specific methanogenic activities of reactor biomass, obtained at the conclusion of the trial, indicated the development of psychrotolerant biomass during the 90-day experiment.
Challenges include the use of adaptive trial designs, the development of standardised, sensitive outcome measures, and the need for interventions that can be implemented in resource-poor settings.
Additionally, the meeting focused on identification of the barriers to conduct such a trial and the development of strategies to overcome those barriers.
However, a major challenge for this type of trial is the development of a dynamic study design aimed at efficiently identifying novel therapeutic approaches and on avoiding large expenditures on unworthy and untested therapeutic agents for serious diseases.
The basis for process redesign are experimental trials and the development of suitable equipment.
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