Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
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...



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.

Welcome To The Estimand: Patient-Reported Outcome Framework Gets Warm Response At FDA/ASCO Workshop

Estimand structure is part of effort to generate standard principles and analyses for patient experience data in oncology and beyond.

EMA Can Do More With Its Guidance On Multiplicity Issues In Clinical Trials, Says EFPIA

EU research-based industry association EFPIA has made several suggestions to improve the European Medicines Agency’s draft guideline on addressing multiplicity issues in clinical trials. Multiplicity can have a substantial influence on the rate of false-positive conclusions, which may affect approval and labeling of an investigational drug.

Topics

UsernamePublicRestriction

Register

PS121510

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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