CARRA Newsletter-June 2018 Issue 1


CARRA Hosts a Multi-Stakeholder Meeting to Discuss Critical Issues Facing Clinical Trials in JIA

Prior to the most recent CARRA Annual Scientific Meeting in Denver (April 2018), CARRA hosted a meeting entitled “New Approaches to Evaluate the Efficacy and Safety of Therapeutics for Juvenile Idiopathic Arthritis (JIA): A CARRA-Sponsored Discussion”. There was an exceptional attendance from the invitees including representatives from UK Paediatric Rheumatology Clinical Study Group and international pediatric rheumatology, the Arthritis Foundation, parents/patients, the Food and Drug Administration (FDA), European Medicines Agency (EMA), and multiple pharmaceutical companies, along with CARRA Registry leadership. The goal of the meeting was to start a discussion addressing current and future issues facing therapeutic clinical trials in JIA from the perspectives of all stakeholders: regulatory agencies, investigators/clinicians, industry and consumers.

 Discussion began by exploring the current state of trials and the critical challenges facing clinical trials in pediatric rheumatology given the explosion of new medications in development that will likely be tested to make them available to JIA patients in various part of the world. The meeting identified valuable insights and suggestions, as well as key focus areas to move forward together. Potential solutions highlighted included: awareness of opportunities at FDA and EMA for investigators and industry to explore novel trial designs; creating guidelines for extrapolation and other new approaches for authorizing medications; improving collaboration between the FDA and EMA; optimizing the use of JIA registries and real world data for post-marketing safety surveillance; and ensuring that trials address questions of importance to patients, families, and clinicians. As a direct result of the meeting, attendees agreed to collaborate on a white paper outlining the issues and potential solutions discussed.

In this Issue...

FDA-EMA Meeting

Fall 2018 Grant Cycle

CARRA at ACR 2018

New: Data Counts Form

Jupyter Notebooks

Upcoming Dates

Registry Update

Arthritis Foundation Update

Overall, the meeting facilitated active discourse between stakeholders regarding the issues facing the conduct of clinical trials in JIA, and most importantly, opened a path for investigators, industry, regulatory agencies and patients/families to collaborate to improve the design, conduct, and review process for clinical trials for new therapeutic agents in JIA going forward.    

Fall 2018 CARRA-Arthritis Foundation Grant Cycle to Open Soon!

Applications for both Large Grants and Small Grants will be due October 1. LOI’s are required for those submitting Large Grants (only) and are due September 1. To be eligible to apply, the project PI for all grants must be a current CARRA member who is up to date on membership dues and membership information (location, contact information, and membership status) is up-to-date. Fellows, residents, and CARRA Executive Committee members are not eligible. For more information, including details on what information needs to be included in a large grant LOI, please review the information posted on the CARRA website for each grant type.

Grant Deadlines
Large Grant Letter of Intent (LOI) due: September 1
Large Grant Applications Due: October 1
Small Grant Applications Due: October 1

CARRA-Arthritis Foundation Large Grant

This funding opportunity supports the development and publication of a clinical or translational project which will immediately impact research projects within CARRA or result in a larger collaborative grant that further develops the CARRA network.  A successful application may be for:

  • An all-inclusive clinical or translational research project
  • A pilot research project, that if successful, could lead to extramural funding

Letter of Intent (LOI) due September 1, 2018

LOI’s are required for those submitting to the Large Grant mechanism and are due 30 days prior to the application submission deadline.  Submission of the LOI is the first step in the large grant application submission process.

The LOI should be a one-page letter which includes:

  • A summary of the full proposal with a short description of aims of the project involved
  • Name of the Principal Investigator(s) and submitting institution(s)
  • A list of key personnel and role(s)
  • A description of how the project aligns with CARRA’s mission

The LOI must be on institutional letterhead and signed by the Principal Investigator(s).

While the LOI is an administrative requirement, it is for informational purposes only.  Approval from CARRA is not needed to proceed with the full application. Investigators will receive confirmation that their LOI has been received by the CARRA grants office.

The online submission system will be open mid-July to begin receiving LOI submissions.  CARRA will begin accepting applications through the online submission system in early September. Applications submitted without the required LOI will not be considered for funding.

CARRA-Arthritis Foundation Large Grant Applications due October 1, 2018
Detailed application instructions will be available soon on the CARRA website.

CARRA-Arthritis Foundation Small Grant

This opportunity is available to support projects in development.  New or early investigators are encouraged to apply and will be afforded special consideration.  The research project can be a pilot, continuation of ongoing research, or other projects that move forward clinical or translational research that furthers the CARRA mission. Preference will be given to research that is collaborative in nature, which leverage current CARRA network resources and/or will further develop the CARRA network.

CARRA will begin accepting applications through the online submission system in early September.

CARRA-Arthritis Foundation Small Grant Application due October 1, 2018
Detailed application instructions will be available soon on the CARRA website.

CARRA Activities at ACR 2018 – Save the Date!

Join CARRA in Chicago during the 2018 ACR/ARHP Annual Meeting. The ACR meeting will take place October 19-24. CARRA is working out the details regarding our set of activities and will provide an update as soon as possible. As in previous years, CARRA anticipates holding a Membership Meeting, followed by a reception co-sponsored by the Arthritis Foundation. The tentative date for the CARRA Membership meeting and co-sponsored reception is Monday, October 22. We hope to see you there!

NEW – Request Form for “Data Counts Only” Now Available on CARRA Wiki

Investigators seeking to assess study feasibility may now use a new form to request general, basic inquiries or patient cohort counts from the CARRA Registry in support of a grant submission or in preparation for a potential research project (via a future data request). Any data provided may ONLY be used for the grant or data application.

Before you submit your request, please consult the appropriate data dictionary and/or CRFs for the data items that are available in the Registry datasets to assess the data that may be available to you. Data should be requested by the primary/principal investigator.

The new form is called the “CARRA Registry Data Count Request” and is available via the CARRA Data and Sample Share Portal on the CARRA wiki.

CARRA researchers can now embed Jupyter notebooks on

The CARRA Member Collaboration Site has been enhanced to support embedding and sharing Jupyter Notebooks in the wiki’s pages with the IPython macro. Jupyter ( is an increasingly popular way to share code, text and visualizations with support for many programming languages.

For a step-by step guide to adding notebooks to your own pages, see and the IPython plugin user documentation is here:

When you’re sharing Jupyter notebooks remember never to post PHI on  If you have any questions about the IPython macro or embedding Jupyter notebooks please email [email protected] for assistance.

Important Upcoming Dates

Registry Announcements

STOP-JIA Update: We need to enroll 24 more STOP-JIA patients to reach the 400 patient enrollment goal by June 30! Also, remember to make every effort to enter data for the 12 month visit for STOP-JIA patients (this is the primary endpoint visit)!

New Registry Site!
Please welcome Wake Forest Baptist Brenner Children’s Hospital as the newest CARRA Registry site, led by site PI Dr. Alysha Taxter! Wake Forest was officially opened to enrollment on May 15, 2018. They’ve already enrolled 8 patients in the Registry, with their first patient enrolled on May 17, 2018. Congrats to our newest site on starting off their enrollment strong! CARRA is excited to have you on board!

Enrollment Update (as of 6/8/18)

Arthritis Foundation Updates


JA Camps

The Arthritis Foundation has camps and family events across the country that provide kids and teens and their families the opportunity to network, learn and play with others in their local community. To learn more about how you can get involved, please contact your local Arthritis Foundation staff.

JA Power Packs

The Arthritis Foundation’s JA Power Pack is a toolkit with useful information and tools to assist newly-diagnosed children and teens, as well as their parents. These resources were designed to give you and your family the power to make living with JA easier. Knowing what to expect and how to deal with it is the key to better living with JA.

Please encourage the patients and families you serve to order a JA Power Pack in one of the following ways:

  • Call the Arthritis Foundation toll-free number, 1-800-283-7800 to place an order
  • Obtain an order form from their care provider and return to the Arthritis Foundation Office printed on the form
  • Complete an updated order form during their clinic visit so their care provider can send to the Arthritis Foundation office
  • Call their local Arthritis Foundation office and order over the phone 
  • Health Care Providers can request a tear-off pad of JA Power Pack order forms by contacting the Arthritis Foundation local office in your area. You can find your local office here.