EMWA members are invited to contribute to the development of a new outcome reporting standard for clinical trial protocols and reports of completed trials, called the Instrument for reporting Planned Endpoints in Clinical Trials (InsPECT).

Inadequate and poor-quality outcome reporting in clinical trials is a well-documented problem that impedes the ability of researchers to evaluate, replicate, synthesize and build upon study findings and impacts evidence-based decision making by patients, clinicians, and policy makers. A need has been identified for internationally-harmonized and comprehensive guidance that is applicable to all outcome types, disease areas, and populations for reporting

outcomes in clinical trial protocols and reports.

In an effort to improve clinical trial reporting quality, reporting guidelines exist for clinical trial protocols (SPIRIT) and completed trials (CONSORT and CONSORT extensions).

InsPECT will build upon these guidelines through two evidence-based reporting extensions, one specific to trial protocols (SPIRIT-InsPECT Extension) and one specific to trial reports (CONSORT-InsPECT Extension).

This project is funded by the Canadian Institutes of Health Research. InsPECT is led by Drs. Nancy Butcher, Martin Offringa, An-Wen Chan, and David Moher.

What are we asking you to do?

Participants will be asked to give their opinion on the importance of identified candidate reporting items for inclusion in clinical trial protocols and reports and to suggest any other items not already on the list via three web-based surveys between November 2018 and January 2019.In addition, we would like to ask you to forward this invitation to any other individuals, groups, networks, or organizations who you believe may be interested in participating in the

InsPECT Delphi study.

How can people participate?

Advance registration is required. Those interested in participating should register at the following link: https://surveys.sickkids.ca/surveys/?s=9D7EMWKMCH, prior to October 31st, 2018. The first survey will be emailed for completion in November 2018.

Why should EMWA members contribute?

Your voice is needed! Input on what should be reported about trial outcomes - from those directly involved in the design, conduct and oversight, publication, and application of clinical trial reports and protocols - is critical to ensuring the InsPECT Extensions provide useful and harmonized guidance.

In particular, InsPECT is seeking input from trial protocol and report authors, clinicians, biostatisticians and epidemiologists, systematic review/meta-analysis authors, reporting guideline and core outcome set developers, journal editors, research ethics board members, and regulators.

All Delphi respondents will be acknowledged in the SPIRIT and CONSORT InsPECT Extension Statements, which will be publicly available and published in peer-reviewed journals.

Where can you find more information about InsPECT?

You can find more information on the InsPECT website: www.inspect-statement.org and on Twitter: @InsPECT2019.

The protocol for InsPECT development and project details are publicly available on the Open Science Framework: https://osf.io/arwy8/. Anonymized project data will also be made publicly available here.

Should you have any questions, please contact Andrea Monsour (andrea.monsour@sickkids.ca), Study Coordinator for the InsPECT project.