MAY 16-17, 2012 NATCHER CONFERENCE CENTER NATIONAL INSTITUTES OF HEALTH CAMPUS BETHESDA, MARYLAND
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1 MAY 16-17, 2012 NATCHER CONFERENCE CENTER NATIONAL INSTITUTES OF HEALTH CAMPUS BETHESDA, MARYLAND
2 FDA Anne Pariser Larry Bauer Mark Walton Gayatri Rao Marianne Noone NINDS Dan Tagle NICHD Tiina Urv Melissa Parisi NIH CC Fred Ognibene NCATS Steve Groft David Eckstein P.J. Brooks Chris Austin John McKew Phyllis Frosst Leslie Kenna Andre Pilon Nuria Carillo
3 Entire symposium was video simulcast There will be a link to the archived video from the NCATS website Slides will be posted on meeting website and available for the public Link will be ed to participants
4 Written summary of findings from the workshop White Paper or Publication Present a case for the importance of NHS Share best practices and common pitfalls Bring in any data from NICHD new born screening panel Follow up with public call for input on common challenges What would be the next steps? Start of an ongoing dialogue in Natural History Studies Funding sources Shared resources (common templates) Incentives for Academic Collaborators First Authorship and High Impact Journals Importance of active patient group involvement Start planning a follow up NHS meeting Volunteers to participate/organize? Choose key challenge and tackle How statistical workup of data will impact data and questions asked Best way to power studies for small patient pops Enable to data to be used at FDA and EMEA Workshop on a step by step approach for new foundations to start down this path
5 Consortium to provide guidance (funding?) for unified Natural History Study design and execution NIH/FDA/Advocacy/Industry Allow data set pooling to prepare good control groups International Compendium of registries Filter by organ Broader collection of pitfalls Rare Disease Atlas for diagnosis and treatment could begin by analyzing current NHS Common data elements/terminology that may allow pooling databases
6 Essential to Therapeutic Development Purpose is scientifically sound clinical development, facilitate drug development, and desire that clinical development will succeed To provide a solid shared scientific foundation for understanding the disease Additional disease knowledge allows changes in patient care To identify diagnostic guidelines and diagnostic tests To get it right the first time, especially in very small patient populations For many rare diseases no regulatory pathway to follow making this information vital Continue to follow NH of a disease after a therapeutic is developed Many underlying facets of the disease become evident
7 Make this a win-win for both researchers and patients/care givers Long term commitment to work together Nurture relationship since both sides want this to be a success Active engagement with a particular rare disease community benefits patients and any future therapeutic development To enable patient retention demands on patients need to be reasonable Multiple individual efforts usually counterproductive Natural History/Disease Specific Clinics can create a Medical Home for patients with rare disease Industry needs this data to plan therapeutic development Data may allow FDA to accept subpopulations for clinical development
8 Design should be therapeutic independent Should be considered pre-competitive space Prior therapeutic development experience helpful in design of study These are usually multi year studies that evolve over time Be mindful of bias in NHS data Retention rates Population characteristics Access to prior results for researchers participating Negotiate data access and publication rights early Have a plan to close out unproductive sites and bring on new ones Try to combine research and clinical visits on the same day Clear delineation but can happen on the same time Good data coordinator is essential! Avoid mission fatigue by not having too many meetings
9 Single Site Same group of experts doing assessments Good data control and quality Patient travel or small geographic draw Multiple Sites Multiple experts doing assessments Continuous training essential Multiple IRB approval Large time investment Central IRB would greatly accelerate multi-site NHS
10 Literature Review Chart Review Prospective Cross Sectional Patient Surveys Prospective Longitudinal Weigh time vs. richness of data package Approach and data collection can change over time
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