Research design
What we are faced with is a newly discovered viral disease, testing drugs are selected mainly based on the past experience of such drugs treating other related diseases. Some of them only had in vitro tests. Some hasn’t finished Phase II clinical trials. Large-scale clinical trials will take a long time. Therefore, the small-scale clinical trials, including Phase II clinical trials, are currently given priority to, in which case, its effect, proper dosage, the medication and adverse reaction are initially verified. Those possibly effective and relatively safe medications can be coordinated to the large-scale and multi-centre clinical trials. In this way, a bulk of repetitive trials are avoided.
Another reality situation is the fact that the National COVID-19 Treatment Guideline has been updated quite urgently to include possibly effective drugs and experts are continuously offering new medical suggestions. Therefore, the medical workers in clinical trials usually take consideration of national guideline and expert opinion, while carrying out the trial under the premise that the normal treatment is not affected. As a result, the intervention group may be covered by a variety of anti-viral medications. It is difficult to leave the control group blank in order to confirm the absolute effect of the testing drug in the intervention group. The specific effects of the testing medication cannot be verified. In this case, the current clinical studies are not as rigorous as the traditional clinical trials, but they help draw a quick initial result which can help with the following study design. It is of vital importance to motivate the quick publication of clinical trial results, which can contribute significantly to clinical treatment.