How iCureCeliac® Can Assist Research

We can assist your research efforts in a number of ways:

• Provide access to our database of information previously collected from iCureCeliac^® participants
• Collect new data from iCureCeliac^® participants, either through the iCureCeliac^® web portal or other mechanisms, on a cross-sectional or longitudinal basis
• Help find participants for your trials, studies or other research activities
• Conduct surveys of iCureCeliac^® participants to help you understand the community’s needs and interests to enhance the impact and feasibility of your research

As of November 2017, more than 4,500 people have joined iCureCeliac^®. The following infographics display cohort findings:

iCureCeliac^® Data: Each registered iCureCeliac^® participant is asked to complete a series of questionnaires on the celiac.org/icureceliac portal. These are completed at enrollment to provide baseline data, and as subsequent survey questions are added. Participants have the ability to change their answers over time.

Currently, there are four surveys in the iCureCeliac^® patient registry. Validated instruments include the Celiac Symptoms Index (CSI), Celiac Dietary Adherence Test (CDAT), Celiac Disease Quality of Life Measure (CD-QOL), PROMIS Gastrointestinal, and PROMIS 29 Profile and PROMIS Pediatric 25 Profile.

We can implement additional surveys as needed to meet the needs of your research study. These can be presented to iCureCeliac^® participants as a cross-sectional survey or on a longitudinal basis. In addition, we have the ability to develop apps or integrate data from existing apps. The current surveys are:

iCureCeliac^® Biosamples: If your study needs samples that can be collected by the participant directly, such as saliva, cheek cells, skin swabs, urine, or fecal samples, or which need to be collected by trained personnel, such as blood, we are happy to discuss and explore options with you.

iCureCeliac^® Electronic Health Records:  In 2018, iCureCeliac participants will be invited to upload any EHRs they may have received from any of their healthcare providers. These EHRs will be available to investigators for use in research studies. We may also be able to facilitate access to EHRs from PCORnet member clinical organizations (see “PCORnet data” below).

PCORnet Data: Through our status as a PCORnet  Patient-Powered Research Network, we are able to propose queries of the data provided by all PCORnet members into the Common Data Model . We are also able to reach out to other PCORnet networks, many of which have data from and about people with celiac disease or focus on symptoms or comorbidities common in celiac disease, to propose research projects involving joint data or sample collection and/or analysis. Data that may be available from PCORnet member networks include EHRs from clinical care providers, patient-reported data from disease registries, and more.

iCureCeliac^® can support many different types of studies depending on the nature and goals of your research program.

Studies using existing data: Data previously collected from iCureCeliac^® participants can be readily shared with researchers. In the future, as we engage in additional research studies, any data as well as any leftover banked biosamples collected specifically for those studies will also be available to other researchers for use in their studies. Our consent processes governing the collection of data and biosamples from iCureCeliac^® participants permit open sharing of these resources with any researcher without the need for additional consent.

Studies involving collection of new data/samples: If your research requires access to data and/or biosamples that have not already been collected, we will be happy to work with you to obtain these resources. We can implement new data collection mechanisms through theiCureCeliac^® platform and/or arrange for collection of biosamples from participants. Data and samples can be collected either from the entire iCureCeliac^® cohort or from specific subgroups, depending on your needs. For some studies, such as those involving the deployment of a new questionnaire on the celiac.org/icureceliac portal, no additional consent will be needed. If an additional consent is needed for activities not covered by our main consent, we will work with you to put this in place.

Studies involving PCORnet data: We can facilitate celiac disease-related studies requiring access to data contained within the PCORnet Common Data Model or collaboration with other PCORnet member networks.

Collaborative studies with other studies and cohorts: We welcome collaborations with studies using other research networks or cohorts, other data collection platforms, and/or other research resources that already exist or are in development. If iCureCeliac^® can enhance the statistical power of your study, provide access to new patient populations, supply valuable patient input to your efforts, and/or provide other types of support, we would be delighted to talk with you.

In addition to developing an iCureCeliac^® research study with you, we can support your research efforts in other ways:

Subject recruitment: If you are recruiting subjects for an existing study, we are able to notify the entire iCureCeliac^® participant community or identified participants. We are also able to provide notice to the Celiac Disease Foundation constituency through email, website posting and social media.

Community feedback: In addition to soliciting input from our community on individual research studies, we can also survey our iCureCeliac^® participants and Celiac Disease Foundation constituency for other purposes. For instance, we have surveyed our community on behalf of the FDA regarding their concerns about the FDA gluten-free labeling rule, gluten in medication, and the need for therapeutic treatment alternatives to a gluten-free diet.

Volunteer recruitment: If you have a research-related activity that would benefit from direct involvement from people with celiac disease or non-celiac wheat sensitivity we can help identify willing and interested individuals to participate. For example, we can provide PCOR-trained patient advocates to serve on advisory panels for research studies or programs.