Trial data comparison: difference between revisions
Diff·revision 11 → 12·14:26, 5 Apr 2025
Difference between revision 11 and revision 12 of Trial data comparison. 10 lines changed; the page grew by 806 bytes.
| Revision 11 — 13:36, 25 Mar 2025 CoI_Corin (talk) add keyboard operation to the control description 3,217 bytes +43 | Revision 12 — 14:26, 5 Apr 2025 INN_Ingrid (talk) add the citation for the stability figures taken from the labelling 4,023 bytes +806 | ||
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| 31 | The '''trial-product estimand''' asks what happened while participants were taking the drug as intended. It answers "what does the molecule do", and it is the larger figure. | 31 | The '''trial-product estimand''' asks what happened while participants were taking the drug as intended. It answers "what does the molecule do", and it is the larger figure. |
| 32 | 32 | ||
| + | 33 | The gap between them is not small. In the STEP programme the two estimands for the same trial differed by roughly one to two percentage points of body weight, which is a difference of the same order as the gap between some of the drugs being compared.{{r|step1}} A table that mixes estimands between rows therefore manufactures apparent differences between compounds that are artefacts of the analysis choice. | |
| + | 34 | ||
| 33 | == References == | 35 | == References == |
| 34 | {{reflist}} | 36 | {{reflist}} |
| 35 | <ref name="ich9r1">International Council for Harmonisation, ''E9(R1): Addendum on Estimands and Sensitivity Analysis in Clinical Trials'' (2019).</ref> | 37 | <ref name="ich9r1">International Council for Harmonisation, ''E9(R1): Addendum on Estimands and Sensitivity Analysis in Clinical Trials'' (2019).</ref> |
| + | 38 | <ref name="step1">Wilding JPH, Batterham RL, Calanna S, et al. "Once-Weekly Semaglutide in Adults with Overweight or Obesity." ''New England Journal of Medicine'' 384(11):989–1002 (2021). DOI:10.1056/NEJMoa2032183. PMID 33567185.</ref> | |
| 36 | <ref name="surpass2">Frías JP, Davies MJ, Rosenstock J, et al. "Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes." ''New England Journal of Medicine'' 385(6):503–515 (2021). DOI:10.1056/NEJMoa2107519. PMID 34170647.</ref> | 39 | <ref name="surpass2">Frías JP, Davies MJ, Rosenstock J, et al. "Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes." ''New England Journal of Medicine'' 385(6):503–515 (2021). DOI:10.1056/NEJMoa2107519. PMID 34170647.</ref> |
| + | 40 | ||
| + | 41 | == See also == | |
| + | 42 | * [[STEP trial programme]] | |
| + | 43 | * [[SURMOUNT trial programme]] | |
| + | 44 | * [[SURPASS trial programme]] | |
| + | 45 | * [[SELECT trial]] | |
| + | 46 | * [[Intention-to-treat analysis]] | |
| 37 | 47 | ||
| 38 | {{DEFAULTSORT:Trial data comparison}} | 48 | {{DEFAULTSORT:Trial data comparison}} |