NOW ENROLLING FOR RESEARCH STUDY
Enroll in the PBC Research Foundation’s study for primary biliary cholangitis patients today! Since PBC is a rare disease, the more participants who share their journey, the more we can learn to improve care. You can read more below and sign up for the study.
Why do we need the PBC Foundation study?
PBC is itself a rare disorder with no cure and because it is a rare disorder, no other patient owned research study collecting regulatory grade data exists. To answer some of the questions about proper care for PBC patients and to hopefully assist in informing new treatment and care options, we need to have large amounts of data. With rare disorders such as PBC, a productive way to really collect this data is through a patient longitudinal study that is non-biased where patients own their data.
We are enrolling all PBC patients into our study but are particularly interested in those experiencing itch!
What will I be asked to do if I join?
Upon entering the website below, you will have a chance to read a more detailed description of the study and then decide whether you would like to participate. Participation is always voluntary and you can stop participating at any point. You will sign an online consent form if you would like to join.
You will then be asked to fill out a series of questionnaires about your past medical history, your PBC journey and any emotional aspects that PBC has had on your life. Each survey should take about 15-30 minutes to complete. You can stop at any point and return to finish the surveys on your own time.
You will also have the option of uploading your laboratory information such as liver function testing or or connecting your patient portal into the secure database where your records will be uploaded automatically. This information is important so that conclusions can hopefully be made with PBC disease progression and response to treatment.
You will also be asked to update your surveys every 3 months. This will allow researchers to help determine the long-term health effects of PBC.
Safety and Goals
We will follow the following guidelines to keep your information safe:
Privacy: The study is being launched on a secure site that is compliant with all regulations including HIPAA. Your data will remain on this site and no identifying information will be shared. This site is through a company who specializes in patient registries and patient studies and keeping data secure. Our study is also approved by an internal review board (IRB).
Patient driven: You choose if you want to participate. You choose if you would like to fill out questionnaires or add your medical information. And you can choose to stop participating at any point. Your personal information (including email) will never be shared directly with anyone outside of the study and it is up to you if you want to contact anybody who is performing research on PBC. You are always in control.
Progress: We are hoping that this patient owned study will make progress in improving care for PBC patients.
Patient experience: We want you to have a voice in sharing your patient experience with the world. We will be adding more surveys in the future focusing on the emotional and psychological aspects of PBC to help spread awareness that PBC is so much more than just liver enzyme elevations, itch and fatigue!
FAQs
1. Is my information secure and safe?
Yes, our platform, The Matrix, is HIPAA and GDPR compliant. Your name will never be disclosed or linked to your data. All answers will remain confidential, and we will never sell your name, email, or answers.
2. What if I only want to participate in part of the study?
You chose what you want to participate in and what you don’t want to participate in.
3. What happens if I change my mind later?
You own your data, and you can keep your digitized record, stop our data collection, or delete your record.
4. How is this different from other surveys?
Other surveys, such as those on social media platforms or apps where you track symptoms, cannot always guarantee data safety and security because they are not on a HIPAA or GDPR-compliant platform. Since anyone with an email address can complete many of those surveys, data duplication cannot be controlled whereas we use the clinical research ID to ensure you are only accounted for once. It is also possible that your answers and information will be sold to others or collected without IRB approval or proper consenting.
5. Can I participate if I live outside of the United States?
Yes! Although some questions will focus on the USA population, all PBC patients are welcome to enroll.
6. Can I participate if I am under 18?
No. You must be over the age of majority in your state or country to sign up for the registry
7. How should I prepare to answer the surveys?
1. collect labs (alk phos) at diagnosis and most recent labs- you can take a screenshot and/or save the file so you can upload
2. Think about your patient journey, what treatments have you tried and when (dates), and why did you switch or start a new treatment?
3. Have your patient portals (my chart, epic etc.) login information and password to connect records so you don’t have to upload them yourself
8. Who do I contact with questions about the registry?
You can email info@pbcresearch.org
Help improve PBC Care and research by signing up today! We need your help and your voice to help learn more about PBC.