The IMPACT Survey is a joint initiative between the umbrella organization Osteogenesis Imperfecta Federation Europe (OIFE), the OI Foundation & the pharma company Mereo BioPharma. The survey was launched the first week of July and is available in eight languages: English, Spanish, French, German, Italian, Russian, Dutch and Portugese. It will be open until September the 10th 2021. We 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 of children with OI to fill in the survey.
Where can I find the IMPACT survey?
The IMPACT survey can be found at https://www.impactsurveyoi.com.
What is the IMPACT survey?
The 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.
What is the target groups?
The survey is developed for the following primary target groups:
- Adults with OI (over 17 years old)
- Parents of children with OI – who don’t have OI themselves
- Parents of children with OI who have children with OI
- Adolescents with OI (12 – 17 years old)
There are different questions based on which target group you belong to.
Who does what?
The survey is run by Wickenstones – an experienced scientific agency who, OIFE, OIF and Mereo Biopharma 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. This basically means that the organizations will decide what the data can and should be used for after the project.
Make sure to take the survey before September 10th!
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.
How many responses are needed from each country?
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. A minimum of 20 participants per country needs to fill in the survey before a national report can be generated. However – if a country should wish to use the data in patient involvement in health technology assessment (HTA), you would probably need at least 40-50 responses from that country as a minimum.
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 reviewers from the European Medicines Agency (EMA) and U.S. Food & Drug Administration (FDA) 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 EMA and FDA. The same goes for the medicinal (health technology assessment) 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 and take ownership of 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 by other companies and projects 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 has been put together in several different languages and shared with the national OI-organizations to assist in this process. Since IMPACT is a global project, the survey and communication materials are available not only in English but also in Dutch, French, German, Italian, Portuguese, Spanish and Russian.
We have also developed a letter to the organizations with tips on how you can help us with PR:
Dropbox folder with communication package
You can find the Dropbox folder with the communication package in all the languages here. OIFE will also add communication material that we have produced to the folder.
Don’t hesitate to ask if you should have any questions about the project. The Executive Committee of OIFE can also attend membership meetings to talk about the project in English or local language if possible. Let us know if you are interested!
We have also developed a Facebook-frame that can be used to create awareness and buzz about the survey. Please feel free to add it to your Facebook-profile if you took the survey and want to encourage others: https://www.facebook.com/profilepicframes/?selected_overlay_id=273684537848536
Are you posting about the IMPACT survey on social media? Please use the hashtag #IMPACTsurveyOI
What is new about the IMPACT survey?
- March 26th 2021 – The background of the IMPACT survey
- May 1st – presentation in Norwegian presented at NFOI Membership meeting
- May 31st – presentation in English presented at OIFE MAB-meeting
- June 5th – presentation in German at DOIG’s Membership meeting
- June 12th – presentation in Spanish at Ahuce’s Membership meeting
- June 18th – the YouTube premiere of the animation video about the IMPACT-survey
- June 19th – the pre-launch of the IMPACT survey at OIFE Annual General Meeting (AGM)
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