Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

ICH Consults On Harmonized Standards For Choosing Estimands In Clinical Trials

Executive Summary

An addendum to the International Council for Harmonisation's guideline on statistical principles for clinical trials proposes a new framework on how the concept of estimands can be used to help clearly describe the effects of a medicine.

You may also be interested in...



EMA Seeks To Update & Improve Guidance On Non-Inferiority Trials

The European Medicines Agency expects its new guideline will improve planning of confirmatory trials that include non-inferiority and therapeutic equivalence comparisons.

Clear Rules Needed For Disclosing Clinical Trial Estimands

Although estimands are a great tool for clarifying the treatment effects that are being investigated in a clinical trial, existing registries are not well suited for their public disclosure. Industry-wide guidance can help sponsors using different approaches. 

Differences Put Aside As ICH Finalizes Guide On Post Approval Changes

An international guideline on managing post approval changes to drugs, which was initially criticized because of its incompatibility with legal frameworks in certain ICH regions such as the EU, has been finalized.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS121510

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel