Table 1. Protocols Referred for Modification.
| Reasons studies needed modifications | No. (%) of studies needing modifications (n = 31) |
|---|---|
| Lack of statistical basis for sample-size calculation | 12 (38.7) |
| Defective inclusion and exclusion criteriaa | 10 (32.3) |
| Defective efficacy and safety indicators | 8 (25.8) |
| Study participants’ risk minimization criteria insufficientb | 8 (25.8) |
| Benefits for future patients or society not described clearly | 5 (16.1) |
| Insufficient team members in key roles | 4 (12.9) |
| Necessary research equipment not available | 4 (12.9) |
| Background evidence not provided sufficientlyc | 3 (9.7) |
| Operating procedures need improvementd | 3 (9.7) |
a
Inclusion criteria were too broad, or exclusion criteria were too narrow.
b
The treatment scheme for expected adverse reactions was incomplete or the criteria for early termination of the study was unclear.
c
The preclinical data or the mechanism of the drug was not fully provided.
d
Operating procedures of plasma treatment, cell therapy, traditional Chinese medicine therapy were not standard.