Table 2.
Characteristics of the first stage briefing dossiers for 95 innovative drug submissions for 2021 drug reimbursement list
| Incomplete information | No (%) of drugs | Inaccurate information | No (%) of drugs | |
|---|---|---|---|---|
| Safety | No reporting of adverse drug reaction monitoring or safety study results | 7/95 (7) | Concealing or misreporting box warning | 9/95 (10) |
| Effectiveness | Study type (RCT, systematic review, etc) not reported | 13/95 (14) | ||
| Country or region of study population not reported | 49/95 (52) | |||
| Comparison with active treatment not reported | 34/95(36) | |||
| No reporting of detailed study design for RCT (with active comparators) | 23/42 (55) | Inaccurate study designs for RCT (with active comparators) | 2/42 (5) | |
| No reporting of detailed study design for systematic review (RCTs with active comparators) | 24/35 (69) | Inaccurate study designs for systematic review (RCTS with active comparators) | 4/35(11) |
RCT = randomised controlled trial.
Information was retrieved from public data released on the website of the National Healthcare Security Administration of China. For the safety dimension, manufacturers’ reports were compared with data from official channels and box warnings on drug labels released by the National Medical Products Administration in China and the US Food and Drug Administration. For the effectiveness dimension, manufacturers’ reports were assessed against Consolidated Standards of Reporting Trials (CONSORT) guidelines.