UPDATE: 

November 15, 2024

PAAB has now seen a number of real-world evidence studies and noted that many have a similar design. The newly published Advisory – RWE: Single Arm Studies of Previously Treated Patients serves as a guide to our approach to this type of study and it intended as a supplement to the Guidance on Real-World Evidence/Data.

We will continue to monitor the types of RWE studies submitted for trends which may be appropriate for additional updates.

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Febraury 1, 2024

The Code update, Guidance on When the Attention Icon is Required and Its Presentation, and Guidance on Real-World Evidence/Data are now in effect. Please ensure that you are referencing back to these links for the finalized versions of the documents.

We look forward to working with you on this updated approach to the sharing of clinical data.

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December 1, 2023

PAAB is excited to announce that the Board has approved the changes to the Code that will allow for the application of the RWE guidance document as well as the use of those same formatting requirements for other data presentations such as subjective endpoints from open-label studies.

The Code change will come into effect on February 1^st 2024. PAAB will not be accepting presentations with data under the Code changes until this date, to allow all companies adequate time to train their staff and assess their portfolios.

PAAB will be working over the next month, to create some additional training documents to assist in application of the new guidances and Code updates and removing “draft” watermark. The Code will be updated to reflect the new wording (found here) on February 1^st.

We would like to thank the RWE Committee once again for all their work and feedback throughout the process, as well as the manufacturers, agencies, and associations who provided extensive feedback throughout the rounds of revisions. We feel the new framework will allow for the inclusion of RWE in advertising in a truthful, transparent and trustworthy manner that will work in the best interest of all Canadians who rely on informed healthcare professionals. With your collaboration, we believe this places Canada at the forefront of marketing best practices and we could not have done it without you.

We look forward to working with you throughout the implementation. Let us know what you think below.

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October 13, 2023:

PAAB is pleased to announce that the draft PAAB Guidance on Real-World Evidence/Data has been forwarded on to Health Canada for consultation. In addition to the RWE document, PAAB has also leveraged the work of the committee to inform additional proposed adjustments to review practices in order to further expand the information that can be shared with HCPs. 

Both draft documents and proposed Code updates can be found here.  

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• RWE Draft Guidance is complete. Industry consultation will last from March 13- April 3^rd. If your organization would like to provide feedback, please coordinate a point person to reach out to Pauline Dong and Jennifer Carroll to acquire the draft document and collect feedback from your organization. We ask that all feedback be collated into a single response provided prior to the consultation deadline.

Please remember that this is a draft guidance. It should not be shared externally.

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In November of 2022, PAAB struck a committee to generate a framework for acceptance of Real-World Evidence (RWE) in healthcare professional advertising. While the framework will focus on evidentiary standards and disclosure criteria pertaining to RWE, it will set the stage for guidance pertaining to other forms of evidence which don’t meet evidentiary gold standards but have value to clinical practice. The committee is dedicated to ensuring the framework promotes the use of RWE in advertising in a manner that is truthful, transparent, trustworthy, and in the best interest of all Canadians who rely on informed healthcare professionals.

The committee consists of industry experts from manufacturers and agencies.

As the committee finalizes the draft document, we will head to industry consultation and consultation with healthcare professionals. Please stay tuned for further development and updates along the development timeline.