Jessie Gruner, Robin S DeWeese, Bronwynne Evans, Marina Acosta-Ortiz, Meg Bruening, Kristi Mollner, Gina Lacagnina, Punam Ohri-Vachaspati
Qualitative Research in Phoenix, AZ, Exploring Support for Public-Private Partnerships to Expand the Reach of the Fresh Fruit and Vegetable Program
Journal of the Academy of Nutrition and Dietetics
public access databases clinicaltrialsgov achieve dissemination clinical trial design aggregated study results however return participantlevel data rarely done key barrier includes proprietary ownership data sponsor additionally investigators may access centralised data per international council harmonisation technical requirements pharmaceuticals human use ich good clinical practice must maintain confidentiality participants study piloted approach return individual aggregate clinical trial data parents children participating series openlabel clinical trials small biotech company obtained central ethics approval centralised institutional review board irb nonexempt study advertised via parent advocacy groups parents trial participants offered option contact employee coordinator within company requesting return childs study results ethics approval covered participation six countries study focused sequential clinical trials vamorolone vbp15002 nct02760264 vbp15003 nct02760277 postresults contact initiated parent enabled coordinator obtain informed consent separate general data protection regulations consent phone translation needed using date birth study site location provided parent data manager reported participant number coordinator coordinator retrieved compiled data along aggregate summary mailed via password protected encrypted memory device parent prereturn postreturn surveys sent consented parents n19 40 48 total trial participants investigators prereturn surveys indicated request much data offered formats offered postreturn survey showed high satisfaction process data returned survey physician site investigators n10 100 participation investigators voiced general satisfaction process reservations pilot study demonstrates innovative costeffective centralised labour conservative approach return participantlevel aggregate data participants studies