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“One of the single most important contributions an individual can make to PWS research is to participate in the Global Prader-Willi Syndrome Registry.

— Susan Hedstrom, Executive Director, FPWR 


 

The purpose of the Global PWS Registry is to enhance the understanding of PWS by describing the full spectrum of PWS characteristics.  The Registry will also facilitate the completion of clinical trials and other research studies in the field of PWS.

The Global PWS Registry is a comprehensive and secure database, compliant with U.S. Health Information privacy laws and FDA regulations.

Managed by the Foundation for Prader-Willi Research (FPWR), the registry will:

  • Document the full range of PWS characteristics
  • Enable data trend analysis to generate new insights into PWS and identify areas for additional study
  • Facilitate partnerships with university researchers and pharmaceutical companies
  • Guide the development of standards of care
  • Expedite the completion of PWS clinical trials
  • Allow participants to store their PWS medical data in one place
  • Accelerate solutions for PWS

We invite you to participate in the Registry. Please register today! You will be asked to provide details on topics such as as developmental milestones, scoliosis, medications, appetite, behavior and other clinical symptoms. Depending on the challenges you have encountered, the registry may take one or more hours to complete. You do not need to complete the entire registry in one sitting.

If you have any questions while completing the registry or encounter any challenges, please contact:
Jessica Bohonowych, Ph.D.
Associate Director of Research Programs, FPWR
info@pwsregistry.org

 


 

“The creation of this registry will allow families to document all of the medical, psychological, and behavioral issues their child may have over time, and to then have an open and complete dialogue with their physicians about these issues. Additionally, this will give families the opportunity to indicate their willingness to be contacted about possible research studies and researchers the possibility of having greater access to those families who wish to participate in research studies.” 

— Dr. Jennifer Miller, University of Florida


 

To get started, go to: htpps://pwsregistry.org

 


Frequently Asked Questions

Q. Why should I join the registry?

The purpose of the Global PWS Registry is to collect and analyze PWS patient data to enhance the understanding of PWS.  The Registry will also help connect registry participants with clinical trials and other research studies for which they may be eligible.

The Global PWS Registry is the next step in PWS research and will advance PWS research faster than ever before. The registry will:

  • Document the full range of PWS characteristics
  • Enable data trend analysis to generate new insights into PWS and identify areas for additional study
  • Facilitate partnerships with university researchers and pharmaceutical companies
  • Guide the development of standards of care
  • Expedite the completion of PWS clinical trials
  • Allow participants to store their PWS medical data in one place
  • Accelerate solutions for PWS

 Q. Is my information secure?

The Global PWS Registry is a secure platform, compliant with:

  • US Health Information Privacy Laws (HIPPA, HITECH, and FISMA)
  • State privacy laws (where applicable)
  • FDA regulations on electronic records (21CFR Part 11) and
  • European Union Data Directive and General Data Protection Regulation

The Global PWS Registry guidelines and procedures has been reviewed and approved by an independent Institutional Review Board (Hummingbird, IRB).  The purpose of the IRB is to ensure that human subject research is conducted in accordance with all federal, institutional, and ethical guidelines.

 Q. Who will be able to access my information?

The information you provide will be made anonymous (de-identified) and will be summarized along with data from other registry participants so that those researching PWS can understand common characteristics and what treatments are being used. FPWR may share your de-identified data with investigators and institutions conducting clinical trials or research studies, companies developing potential drugs or other treatments for PWS or to other parties involved with PWS research. Any information that identifies you will be removed.

Q. I want to be involved in PWS clinical trials, how will I be contacted?

This registry will help match participants with potential clinical trials. If your profile matches the needs of an upcoming clinical trial, you will be notified of the opportunity to participate and will be provided with the contact information for the study coordinator. You will have the option to follow up with the study coordinator and determine if the study is the right fit for you.

Q. I completed the Registry last year, why am I being asked to complete the surveys again?

We ask Registry participants to update their data every year so that the database reflects the most current information on its patients.

Q. I’m in PWSA(USA)’s database, should I join the Global Registry, too ??

Yes! The Global PWS Registry and the PWSA(USA) are different in important ways. The Global PWS Registry is unique in that the Registry questions and protocol have been reviewed and approved by an independent IRB, and the data is collected after participants provide ‘informed consent’.  Only data collected in this way (ie, compliant with the policies of the NIH Office of Human Research Protection) can be fully utilized by university and government (NIH, FDA, etc) researchers and published in major medical journals.  The procedure for matching participants with clinical trials has also been reviewed and approved by the IRB, facilitating patient recruitment.  Finally, the Registry information is maintained in a secure manner, compliant with patient privacy laws.

Q. Where can I get additional information?

The Registry Protocol and Informed Consent documents, which details how data is collected, stored and used, are available below. If you have additional questions, please email us at info@pwsregistry.org, or call FPWR at 888-322-5487.

Q.  How long will it take to fill out the registry?

The initial registration and general medical history will take 20-30 minutes to complete.  After that process, the registry will lead you to a list of forms on different aspects of PWS (e.g., behavior, scoliosis, medications). Depending on how many complications the person with PWS has experienced, this section may take 30 – ??1.5 hours to complete. We know that your time in very valuable and we appreciate your willingness to provide information so that the full spectrum of PWS characteristics can be determined.  Entry of information into the registry does not have to be finished in one sitting – the data entered will be stored and can be completed at a later time, although we encourage you to complete the process as soon as you can.

Informed consent for Global PWS Registry

Protocol-for-Global-PWS-Registry