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Table 2 Data quality from RCTs for oncology drugs with conditional vs. unconditional appraisalsa

From: Comparison of post-authorisation measures from regulatory authorities with additional evidence requirements from the HTA body in Germany – are additional data requirements by the Federal Joint Committee justified?

 

Conditional appraisals

(N = 12)

Unconditional appraisals

(N = 9)

Total

(N = 21)

Number of RCTs presented in manufacturer’s dossier (mean ± SD)

1.3 ± 1.2

1.0 ± 0.5

1.2 ± 1.0

Number of patients in largest RCT (mean ± SD)

577 ± 207

939 ± 361

729 ± 329

Number of control arms (mean ± SD)

1.1 ± 0.3

1.0 ± 0

1.1 ± 0.2

Use of an active control (n, %)

8 (67 %)

3 (33 %)

11 (52 %)

Benefit outcome influenced by potential for bias

8 (67 %)

1 (11 %)

9 (43 %)

Direct comparison to appropriate comparator available

9 (75 %)

7 (78 %)

16 (76 %)

  1. RCT randomised controlled trial, SD standard deviation
  2. aExcluding orphan drugs