NeuroNEXT

NN106 CYTO-C Prospective biomarker study results have been published in Neurooncology Advances.  

Results of the NN103 study were cited in NeurologyLive.  

The results of the NN103 Beat MG have been posted online at the American Academy of Neurology.  

Congratulations to Dixie Ecklund, Director of Operations at the NeuroNEXT DCC, for being selected to join the Society for Clinical Trials Class of 2021 Fellows! Ecklund will be recognized as a new inductee at the virtual SCT annual meeting in May.

A NeuroNEXT Fellowship can help young neurology faculty develop their careers, as highlighted by Wake Forest University in an article about former NeuroNEXT Fellow and Clinical Trials Methodology Course (CTMC) alumnus Dr. Heidi Munger Clay (see link below).

We are pleased to announce that the NINDS Clinical Trials Methodology Course (CTMC) is accepting applications for the 2021 cohort. The overarching goal of the CTMC is to help investigators develop scientifically rigorous, yet practical clinical trial protocols. Our focus is on investigators who have not previously designed their own prospective, interventional clinical trials.   

Course: 

Due to the uncertainty and variations nationwide with the pandemic restrictions and vaccine availability the CTMC External Advisory Board and Course Directors decided that the 2021 Course will be virtual. The 2021 Course will begin late April through November, including an intense portion from July 19-22. Attendance is REQUIRED for the intense portion and the schedule will take into consideration the virtual format.  

In addition, the 2021 cohort will have training opportunities in 2022  with ongoing support through mentorship. Since we anticipate being able to resume with in-person activities in 2022 the 2021 cohort will have the unique opportunity to attend the in-person residential portion of the Course in July 2022. This will allow for networking, peer review experience, and additional time and instruction with CTMC esteemed faculty. (More details will be provided late next year). 

Who Should Apply? 

Qualified applicants from clinical disciplines focused on neurological disease or injury (including, but not limited to pediatric and rare diseases), along with biostatisticians working on projects with clinical neuroscience researchers should apply. All preliminary trial ideas are encouraged, but it is REQUIRED that protocols be focused on the clinical neurosciences. Trainees should have content area mentors to assist them with the science and implementation of their project. A small number of projects may qualify for additional work using clinical trial simulation.  

DEADLINE: 

The application submission deadline is February 28, 2021 at midnight, Pacific Time. Application forms and additional details are available on the course website. Early applications may be considered for early acceptance.

NeuroNEXT Leadership would like to thank everyone for another successful annual meeting! We were able to celebrate several milestones in our virtual format, including: 

• Stephanie Lowenhaupt’s retirement from the University of Virginia. Stephanie has been a NeuroNEXT coordinator from the inception of the Network. Everyone agreed that she will be missed very much, but we wish her the best in this next chapter!
• Amy Bartlett’s service on the NeuroNEXT Executive Committee. Amy’s tenure on the NEC will end in December. Amy is the NeuroNEXT Coordinator at Ohio State University, and has been the coordinator representative since October, 2018. Thank you, Amy, for your service!
• David Clifford’s service on the NeuroNEXT Executive Committee (NEC). David’s tenure on the NEC will end in December. He is the NeuroNEXT site PI at Washington University, and has been one of two site PI representatives on the committee since November, 2017. Thank you, David, for your service!
• Corinne Griguer’s service on the NeuroNEXT Executive Committee (NEC) and leadership of NN106. In anticipation of finishing NN106, we thank Corinne for her service on the NEC as the NN106 PI! She joined the committee in March, 2016 at the start of the NN106 project. 

A message from the Executive Committee of the Clinical Trials Methodology Course (CTMC): 

Due to the global COVID-19 (Coronavirus) pandemic and the number of uncertainties that accompany such a health crisis, the Clinical Trials Methodology Course (CTMC) Executive Committee has decided to postpone the Course until next year.

The Executive Committee would like to thank everyone for the work and time you put into the course and applications thus far. We are currently compiling each application’s detailed feedback received from the reviewers and will email them to the applicants within the next couple of weeks. We encourage everyone to apply again next year and to use this feedback for next year’s application. Priority review will be given to those applications in 2021.

 We recognize that postponing this year’s course impacts clinical trial plans and learning; therefore, we are exploring the possibility to schedule a few educational webinars this summer. Applicants will be invited to these webinars and other educational opportunities as they arise. Please view any material posted on the CTMC website as well. 

 Please email ninds-ctmc-info@umich.edu if you have questions or concerns.

Thank you for your understanding and time.

Best regards,

CTMC Executive Committee

A message from Merit Cudkowicz and Christopher Coffey, March 18, 2020: 

Dear NeuroNEXT PIs and Coordinators,

 We would like to share some updates regarding NeuroNEXT Network response to the evolving COVID-19 crisis.

 As you all know, the COVID-19 situation and response is evolving rapidly.  There has already been and will likely continue to be significant impact on NeuroNEXT Clinical Study Site (CSS) staff and participants. We know that many sites have been required to transition study staff to work remotely and to limit on-site clinical research activities. Participant travel has also been impacted in some cases. The CCC and DCC have already received many communications and questions from NN sites.  The caring and efforts demonstrated by CSS and NN site staff have been amazing (although not surprising)!! Many thanks to all!!

 The NIH has issued some general guidance related to NIH funded studies (see link below). The guidance addresses things like transition to remote participant visits, impact on study and grant timelines, strain on site resources, etc.  The PPIs and their study teams will be reviewing this guidance closely as they develop study specific guidance and guidelines which will be shared with CSS teams in the coming days.

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-087.html

 The  Core study teams at the CCC and DCC, with guidance from NeuroNEXT Leadership, are working closely with the Protocol PIs to develop study specific guidance that will include recommendations and requirements for participant follow up and reporting for the NN107 and NN108 studies.  The NN109 and NN110 study teams and PPIs are also working to determine what impact there might be to site and study start up and how any impact may be mitigated. The NN106 study team is also assessing whether or not ongoing chart extraction and/or site close-out activities may be impacted.

We encourage you and your CSS teams to continue to reach out to the study teams at the CCC and DCC with any questions or concerns and to be on the lookout for forthcoming study-specific guidance .  The teams at the CCC and DCC will do our best to respond as quickly as possible.

Wishing continued good health to all!!

 Merit and Chris

The Association of Clinical Research Professionals (ACRP) has selected NeuroNEXT Project Manager Joyce Moran from our Columbia University Medical Center and Weill Cornell Medical College clinical sites to become a Fellow of the ACRP (FACRP). This FACRP designation represents a global mark of distinction for Joyce; each year, only a handful of clinical research professionals are selected worldwide! This honor recognizes Joyce for her many substantial contributions to the field and designates her a ‘global leader in clinical research.’ Please join the network in congratulating Joyce on this well-deserved honor!