Draft methodology document, version 4

§1Consultation and window

§1.1Window

Opened

31 July 2026

Closed

28 August 2026

Duration

28 days

Status

Open — submissions are being received

Document under consultation

Methodology

Submissions received

21

§1.2Consultation questions

The secretariat put the following questions. A submission was not required to address them and several did not; the questions record what the Institute was uncertain about rather than restricting what a respondent could raise.

1. Is the new section on sponsor-conducted evidence workable, given that for several compounds in the assessment set every contributing trial shares a sponsor?
2. Is the screening procedure described in enough detail to be reproduced by a reader who wished to check it?
3. Does the document state clearly enough which of its provisions bind the assessment committee and which are descriptions of practice?

§1.3How a submission is handled

• Every submission is signed. The Institute publishes no anonymous submission.
• Every submission carries a declared interest. A declaration of no interest is itself a declaration and is recorded as one. A declaration is not a disqualification and the Institute has never given a submission less weight on that ground.
• A submission from an employee of a marketing-authorisation holder is identified as an industry submission on its face, following a unanimous consultation on the conflicts policy.
• Every submission receives a secretariat response and a disposition. Submissions that are not accepted remain published in full; the Institute does not remove a submission because it disagrees with it.
• There is no voting, no reputation score, no reply thread and no editing after receipt.

§1.4Making a submission