Designing trials for uncommon diseases and therapeutics. Mark Walters
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1 Designing trials for uncommon diseases and therapeutics Mark Walters
2 What are Hemoglobin? Alterations in the hemoglobin molecule that adversely affect its abundance and/or function and stability Account for the most common human genetic world-wide Associated with anemia, reliance on RBC transfusions, chronic illness
3 .. Sickle Cell Disease and Access to Care: A National Challenge Globally 350,000 births annually with SCD SCD most common disease screened in newborns in US with estimated 100,000 affected persons Sickle cell disease (SCD) is now a chronic adult disease characterized by poor quality of life with end organ failure and acute intermittent medical emergencies Overall survival for ADULTS with SCD has not improved
4 Trends In Mortality Rates and Age of Death In Sickle Cell Disease (SCD):
5 Pain Frequency: Histogram days 25 % Pts 20 <5 days days Percent Days in Pain 30% of subjects had pain nearly every day Only 13% of subjects almost never had pain
6 Structural barriers to access No or inadequate health insurance Provider attitudes about trial participation Decentralized delivery of care Access to competent, culturally sensitive, intensive/novel/technically challenging therapies is challenging or absent in many venues
7 Is the grass-roots political organization/philanthropic foundation to support an expansive clinical trials agenda adequate? Contrast SCD with hemophilia and CF Professional society involvement
8 Institutional support Is this disease and advancing its quality and breadth of care a priority? Is there a financial and intellectual commitment? Or is it an economic burden?
9 Infrastructure for conducting clinical research is thinning or disappearing and is often under duress Long-term investment in infrastructure by:?institutions or other local resources?state health resources?federal agencies Often inadequate to meet the need NHLBI leadership initiative to engender long-term investment could elicit broad benefits Support and emphasis by key professional societies (ASH) also can yield benefits
10 Comprehensive Centers for SCD (and thalassemia) with patient databases and infrastructure ensure access to and enrollment in clinical trials The transition to alternate models of support (Research to Health Services) for comprehensive centers caused gaps in retention that adversely affected clinical trials Success of many trials is having up-to-date database, large catchment and experienced workforce
11 Funding for trials is elusive There has been a swing in clinical trial sponsorship from NIH-centric (investigatorinitiated) to industry/pharmaceutical centered interests (follow the funds) This transition has caused a shift in priorities
12 Investigator burn-out caused by these obstacles in conducting clinical trials Migration to other disciplines where there are better academic opportunities or to industry
13 Advisory boards elicit expert advice to NHLBI but these are not necessarily empowered to effect policy shifts Regulatory pathway to trial initiation is timeconsuming balancing subject safety, trial design review with timely completion is challenging
14 Global geographic distribution of research subjects is outside N. America and Europe Establishing international partners is vital Comprehensive programs for adults are under-developed and improvement would yield progress in trials
15 Concept to First Enrollment BMT CTN 1503 Stride 2 (ph II biological assignment comparison study of BMT for SCD) NHLBI workshop Oct 2008 BMT for adults with SCD is a priority for development develop consensus for protocol, develop study network, consult with NHLBI 2010 apply for R34 NHLBI planning grant NGA 2011 hold by OHRP re: minor donors safety protocol development, SOPs, IRB, first pt enrolled in R34 STRIDE July 2012; 6 mo. pause for toxicity, expand to URD BMT NHLBI meeting preapproval R01 budget >$500K but <$1.515M; Enrollment of 22 pts in pilot STRIDE completed June 2015 R01 application Oct with partner BMT-CTN as DCC 2015 score not funded, resubmitted July 2015, funding approved Sept STRIDE 2 (BMT-CTN 1507) submitted to PRC 10/15, approved 12/15, submitted DSMB 1/16, approved 4/16, protocol released to centers 4/29/16
16 Concept to First Enrollment BMT CTN 1503 Stride 2 (ph II biological assignment comparison study of BMT for SCD) Single IRB designated as the preferred option for BMT-CTN trials and sites consider this option June 2016 CMS authorizes participation in 1503 under CED designation Renew contract with Sponsoring institution 08/16 MTA vs. waiver for biorepository at Emory IRB submissions Sept Site initiation visits Oct-Nov 2016 Study activated and open for enrollment first 3 sites early Dec years enrollment, 2 years followup Publish results? 2021
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