The IMPACT Survey is a joint initiative between OIFE, OIF & the pharma company Mereo BioPharma. The survey will be launched in June 2021 and we will need the help of all our member organizations and the OI-community to spread the word and encourage as many people with OI (and parents) to fill in the survey. 

What is the IMPACT survey?

The upcoming IMPACT Survey is an international research project exploring the real impact OI has on people’s lives. The IMPACT Survey is aimed at capturing and quantifying the true challenges of life with OI to enable better diagnosis, treatment and care, and to support availability of potential future treatments for OI

Who does what?

The survey will be run by Wickenstones – an experienced scientific agency who Mereo have engaged to do the work. The overall process is governed by a Steering Committee with representatives of OIFE and OIF as well as expert OI physicians from Europe and the US treating children and adults.

Who will manage the data?

The data will be gathered on a totally confidential and anonymous basis, with no personal identifiable information. It will be securely stored by Wickenstones according to Data Protection Regulations. The data will then be analysed according to the plan developed by the Steering Committee, to prepare the first publication. Once the first analysis is finished, the anonymous data will be transferred to a Data Management Committee, comprised of OIFE and OIF, and Dr. Frank Rauch (chair). In agreement with OIFE and OIF, the results will also be shared with Mereo and its partners for planning potential pathways for OI-treatments being evaluated by national payer authorities. Under no circumstances will the information be used for anything without the permission of the Data Management Committee.

When will it happen?

The survey will be launched end of June 2021 and we will need the help of all our member organizations and the OI-community to spread the word and encourage as many people with OI (and parents) to fill in the survey. The survey will be open until September 10th 2021 and once it’s completed, the results will be collected on an anonymous basis and put forward for publication in a peer-reviewed, scientific journal.

What will the organizations get?

The collected aggregated and consolidated results for each country will also be given to the national OI member associations in the countries to use in local policy work, for instance when lobbying for multidisciplinary care or adult clinics. This means, that the more people who answer the survey in a local country, the stronger the data that can be used for later policy work, will be.

Why is lack of data a problem in rare conditions like OI?

Rare conditions like OI have few people and we are spread around the world. There is also a great variety within the condition.  The FDA and EMA reviewers may have to make their decision based on relatively small studies and with a limited understanding of the natural history or progression of the condition. The reliability and quality of the data are critical for the decision making of the European Medicines Agency (EMA) and U.S. Food & Drug Administration (FDA). The same goes for the medicinal authorities in each country. This is why bigger and better data is needed. We think this educational video from the rare disease umbrella NORD explains it in a good way. The video only refers to the FDA (USA), but the system is quite similar to the European one regarding this stage of the process.

Better data for access to treatment and policy work

Even if the survey was originally initiated by Mereo Biopharma, the OIFE and OIF fully supports the project, because we regard it as mutual beneficial. Not only can the data be used in processes connected to Mereo’s work, but it will also be helpful for other future potential treatments being developed and for the policy work in the national organizations. Several rare disease federations are doing similar projects, simply because they see that access to orphan drugs relies on bigger and better data. This is why we strongly encourage you to support the project – and make it the biggest and best OI-survey possible. Bigger and better data matters – and with your help we can develop it.

How can the organizations help?

A communication package and a landing page will be put together in several different languages and shared with the national OI-organizations to assist in this process. Since IMPACT will be a global project, the survey and communication materials will be available not only in English but also in Dutch, French, German, Italian, Portuguese, Spanish and possibly some more languages. The IMPACT survey will be one of the main topics at the OIFE AGM on June 19th. But don’t hesitate to ask if you should have any questions about the project before that time. The Executive Committee of OIFE is also interested in attending membership meetings to talk about the project. Let us know if you are interested!

Where can I find the IMPACT survey?

The IMPACT survey will be hosted at https://www.impactsurveyoi.com. Before the survey is launched you will find a landing page with preliminary information.

What is new about the IMPACT survey?

Questions?

Send an email to president@oife.org

 

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