ELEVATEU LLC — Department of Health and Human Services SBIR Phase I: NIDA

Description

Project SummaryThis proposal seeks to determine the feasibility and acceptability of developing an online platform to facilitate participant recruitment and enrollment in drug abuse studiesThis is an urgent area of researchdeaths from drug addiction and overdosesuch as from opioidshave been rising steadily over the past two decades and have become the leading cause of injury death in the United StatesThe federal government spends overbillion dollars annually to fund drug abuse researchhowevera large percentage goes toward findingrecruitingand enrolling participantsRecruitment and enrollment are costly and time consuming for investigators in all areas of researchbut social and legal concerns further hinder participation in drug abuse researchOnline registries exist and are growing in popularitybut suffer from important limitationsDue to advancements in technology and online advertisingall of these limitations can be addressed with a new technologyWe propose to build the first research volunteer website that streamlines the enrollment process into an integratedidentity validated platform including participant registration recruitmenteligibility screeninginformed consentand survey administrationThis will reduce the effort and cost needed to begin drug abuse studiesprovide an acceptable means for drug users to interact with researchersand improve data quality and securityWe are first focusing this technology in the drug abuse space because of the tremendous difficulty in recruiting drug abuse participants and the growing market in this areaAs of this writingthere areclinical trials funded by NIDA actively recruiting participantsThe pharmaceutical industrywhich has a large stake in drug addiction researchspendsbillion dollars per year on participant enrollment in studiesof the industryandapos s collective clinical trial budgetOnce it has been tested in this areathe platform model can be scaled and commercialized to many other areasMore than $billion was spent on patient recruitment to health research inand such expenditures are growingannuallyThereforethis platform has enormous potential for both commercialization and public health impactIn Phase Iwe will build the platform and conduct aweek pilot study with interested researchers and participantsWe propose the following specific aims to address this researchassess the feasibility of the platformassess the acceptability usability of the platform to participantsandassess the acceptability usability of the platform to researchersOur team includes the former CFO of Epic Systemsand two time successful entrepreneurthe Associate Chief Medical Information Officer for Cedars Sinaia patent attorney at a large Silicon Valley intellectual property firm specializing in digital health portfoliosas well as clinical and research experts who conducted the formative research studies leading up to this application Project Narrative The participation of drug users in drug abuse research is a critical for addressing the growing number of deaths and injuries from overdosesuch as from the opioid epidemicHoweverrecruitment and enrollment in this stigmatized area of research is incredibly challengingtypically taking up a significant portion of study timelines and budgetsDeveloping and pilot testing an innovative online participant recruitment and enrollment platform meeting the unique needs of the target population is a highly promising endeavor becausethe platform would facilitate advancements in drug abuse prevention and treatmentwhich saves lives and moneyandthe platform has substantial commercialization potential as academic and pharmaceutical researchers would save money and time by using the platform