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Outline
Phase Ⅱ clinical trial is a very important step during the clinical development of new drugs. The main purpose in phase Ⅱ is to explore the dose-response information, evaluate the efficacy and toxicity of new drugs as well as provide dosing regimens for the confirmatory clinical trials. In the present paper, the types and designing schemes of phase Ⅱ clinical trials, the objectives, and statistic methods are discussed and presented with examples. The contents presented in this paper help analyze the deficiencies existing in the dosing finding study when it is designed with paralleling study with two test dosage groups vs one positive control. Researchers can also benefit from the present paper for rational schemes for designing phase Ⅱ clinical trials as well as strategies for pushing the clinical trial forward.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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