The consequences of a wholly sponsor-generated evidence base — amendment log
Every change made since protocol registration, with its date and reason.
§5Amendment log
Every change made to this review after protocol registration is recorded below with its date and its reason. A change that is not in this log did not happen. The Institute publishes the log in full, including changes that did not alter a conclusion, because a reader cannot judge which changes matter unless all of them are visible.
§5.1Amendment log
Table 9. Amendments to this review since protocol registration.
| Date | Version | Amendment | Record |
|---|---|---|---|
| 23 Feb 2024 | 0.1 | Protocol registered | The review protocol was registered with the Institute’s secretariat before the search was executed. No change to the review question was made after registration. |
| 10 Aug 2024 | 2.1 | Search re-run | The search was re-run to the current cycle date. Newly identified records were screened against the registered criteria without modification of those criteria. |
| 16 Nov 2024 | 2.2 | Certainty rating revised | The certainty rating for one outcome was revised following the addition of a contributing study. The rationale is recorded in the certainty assessment section. |
| 01 Apr 2025 | 2.3 | Analysis method changed | The pooling method was changed from a fixed-effect to a random-effects model following observation of between-study heterogeneity exceeding the pre-specified threshold. |
| Current version 2.3, ratified in the 2024 Q2 assessment cycle. | |||
§5.2Clinical study report requests
Table 10. Clinical study reports requested for the contributing trials, and the outcome of each request. Refusals are recorded because a review that does not record them presents the sponsor's disclosure decision as the Institute's own.
| Trial | Requested | Outcome |
|---|---|---|
| ACHIEVE-1 | 14 Dec 2023 | Redirected to a data-access portal |
| ACHIEVE-2 | 19 Feb 2024 | No response |
| ATTAIN-1 | 20 Feb 2024 | Refused |
| ATTAIN-2 | 15 Feb 2024 | Partially supplied |
| ECNO-PH3-CN-OBESITY | 29 Dec 2023 | No response |
| ECNO-PH3-CN-T2D | 25 Feb 2024 | Partially supplied |
| ESSENCE | 18 Dec 2023 | Supplied on request |
| EXENATIDE-GE-PD | 16 Dec 2023 | Partially supplied |
§5.3Superseded versions
Superseded versions of this review remain published at a stable address, are marked as superseded, and link forward to the current version. The current version links back to each of them. That practice was adopted following a submission that a document cited in the literature must remain retrievable in the form in which it was cited; the reasoning is published on the corrections policy disposition page.