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Subgroup analysis in Haematologic Malignancies Phase III Clinical Trials: A systematic review
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  • Nerea Báez Gutiérrez,
  • Héctor Rodríguez-Ramallo,
  • Laila Abdel-kader Martín,
  • Sandra Flores-Moreno
Nerea Báez Gutiérrez
Virgen del Rocio University Hospital
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Héctor Rodríguez-Ramallo
Virgen del Rocio University Hospital
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Laila Abdel-kader Martín
Virgen del Rocio University Hospital
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Sandra Flores-Moreno
Virgen del Rocio University Hospital
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Abstract

Aims: To assess the appropriateness of the use and interpretation of subgroup analysis in haematology randomized clinical trials (RCT). Method: A systematic review of Medline including Haematology phase III RCT published between January 2013 and October 2019 was carried to identify subgroup analysis reported. Information related to trials characteristics, subgroup analysis reported and claims of subgroup difference were collected. Results: A total of 98 studies reporting subgroup analyses were identified. Of those, 24 RCT reported 46 claims of subgroup difference. Among them, 44 were claims for the primary outcome, of which 25 were considered strong claims and 17 were considered suggestions of a possible effect. Authors included subgroup variables for the primary outcome measured at baseline for 38 claims (n = 86.36%), used subgroup variable as stratification factor at randomization for 15 (34.09%), clearly prespecify their hypothesis for 11 (25%), the subgroup effect was one of a small number of hypothesised effects tested for 17 (38.36%), carried out a test of interaction that provide statistically significant for 18 (40.91%), documented replication of a subgroup effect with previously related studies for 11 (25%), identify consistency of a subgroup effect across related outcome for 10 (22.72%), and provided a biological rationale for the effect for 8 (18.18%). Of the 44 claims for the primary outcome, 34 (77.27%) met 4 or fewer of the 10 credibility criteria. Conclusion: Credibility of subgroup claims reported in haematology RCT lack of credibility, even when claims are strong. Information about subgroup difference should be interpreted ca

Peer review status:POSTED

03 Jun 2020Submitted to British Journal of Clinical Pharmacology
04 Jun 2020Assigned to Editor
04 Jun 2020Submission Checks Completed