Draft indication set and anchor outcomes

§1Consultation and window

§1.1Window

Opened

9 August 2023

Closed

23 September 2023

Duration

45 days

Status

Closed — the disposition is published

Document under consultation

Document series

Submissions received

15

§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 anchor outcome selected for each indication the outcome a decision would actually turn on?
2. Should a surrogate outcome ever serve as an anchor, and if so under what recorded conditions?
3. Are any indications missing from the set that the Institute should be assessing against?

§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.

§1.4Outcome

The indication set was ratified with amendments. Two anchor outcomes were changed, a surrogate anchor is now permitted only where the document records the validation evidence for the surrogate, and three indications were added.

The disposition table, listing each submission with its disposition and the resulting amendment, is at §3.