Hi All, Just a heads up that ADAPTABLE is moving forward. Iowa IRB is close to completing their review as well. Exciting times….
Russ From: Adrian Hernandez, M.D. [mailto:adrian.hernan...@duke.edu] Sent: Monday, February 08, 2016 12:17 PM To: Thomas Carton; Russell Rothman; McTigue, Kathleen; Rachel Hess; Rainu Kaushal; Lucila Ohno-Machado; Russ Waitman; Terry Mazany; Gary E Rosenthal Subject: ADAPTABLE First 100 All In the next day, all the CDRNs participating in ADAPTABLE should receive their final packets for IRB approval for the ADAPTABLE trial. While its been a longer road to get here than expected but I’m hopeful that the upfront investment in time/energy that has been placed will pay off dividends. To that end, we are going to really need your help, as CDRN leaders, and feedback to push forward the final administrative hurdles for getting ADAPTABLE launched. Please let me know about any issues you hear about with either contracting or IRB. We’re going to pushing out information to you all regarding where things stand so we can learn from each other. In addition, there is a ton of interest in the early success of the ADAPTABLE trial from multiple external stakeholders (NIH, FDA, Industry) and specifically regarding the approach towards creating a National Evidence Generation System. PCORNet and ADAPTABLE will be specifically highlighted in an upcoming public workshop (Enhancing the Application of Real-World Evidence in Regulatory Decision Making) scheduled for March 3/4 in DC. Interested parties will want to see how PCORnet is able to deliver pragmatic randomized clinical trials at a scale that incorporates e-approach/e-engagement/e-consent/e-randomization/e-follow-up. In this regard, we are encouraging everyone to consider approach and time to get to first 100 patients for each CDRN ala PCORnet style. Typically, we consider time to first patient in (FPI) or last patient out (LPO) as metrics of success but of course the interest for PCORnet is to do things @ 10X! Best Adrian ______________________________________________ Adrian F. Hernandez, MD, MHS Director, Health Services and Outcomes Research Faculty Associate Director Duke Clinical Research Institute PO Box 17969 Durham, NC 27715 Phone 919-668-7515 Mobile 919-812-3463 Fax 919-668-7058
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