This proposal seeks to determine the feasibility and acceptability of developing an online platform to facilitate participant recruitment and enrollment in drug abuse studies. This is an urgent area of research; deaths from drug addiction and overdose, such as from opioids, have been rising steadily over the past two decades and have become the leading cause of injury death in the United States. The federal government spends over 1 billion dollars annually to fund drug abuse research, however, a large percentage goes toward finding, recruiting, and enrolling participants. Recruitment and enrollment are costly and time-consuming for investigators in all areas of research, but social and legal concerns further hinder participation in drug abuse research. Online registries exist and are growing in popularity, but suffer from important limitations. Due to advancements in technology and online advertising, all of these limitations can be addressed with a new technology. We propose to build the first research volunteer website that streamlines the enrollment process into an integrated, identity-validated platformâincluding participant registration recruitment, eligibility screening, informed-consent, and survey administration. This will reduce the effort and cost needed to begin drug abuse studies, provide an acceptable means for drug users to interact with researchers, and improve data quality and security. We 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 area. As of this writing, there are 400 clinical trials funded by NIDA actively recruiting participants. The pharmaceutical industry, which has a large stake in drug addiction research, spends 1.89 billion dollars per year on participant enrollment in studies (40% of the industry's collective clinical trial budget). Once it has been tested in this area, the platform model can be scaled and commercialized to many other areas. More than $2.3 billion was spent on patient recruitment to health research in 2010, and such expenditures are growing 15% annually. Therefore, this platform has enormous potential for both commercialization and public health impact. In Phase I, we will build the platform and conduct a 12-week pilot study with interested researchers and participants. We propose the following specific aims to address this research: (1) assess the feasibility of the platform, (2) assess the acceptability/usability of the platform to participants, and (3) assess the acceptability/usability of the platform to researchers. Our team includes the former CFO of Epic Systems (and two-time successful entrepreneur), the Associate Chief Medical Information Officer for Cedars-Sinai, a patent attorney at a large Silicon Valley intellectual property firm specializing in digital health portfolios, as well as clinical and research experts who conducted the formative research studies leading up to this application.
Public Health Relevance Statement: Project Narrative The participation of drug users in drug abuse research is a critical for addressing the growing number of deaths and injuries from overdose, such as from the opioid epidemic. However, recruitment and enrollment in this stigmatized area of research is incredibly challenging, typically taking up a significant portion of study timelines and budgets. Developing and pilot-testing an innovative online participant recruitment and enrollment platform meeting the unique needs of the target population is a highly promising endeavor because (1) the platform would facilitate advancements in drug abuse prevention and treatment, which saves lives and money, and (2) the platform has substantial commercialization potential as academic and pharmaceutical researchers would save money and time by using the platform.
Project Terms: Address; Advertising; Alcohol or Other Drugs use; Area; Budgets; Cessation of life; Charge; Clinical Research; Clinical Trials; combat; commercialization; Consent; Consumption; cost; Data Quality; Data Security; design; digital; Drug abuse; drug abuse prevention; Drug Addiction; Drug Industry; Drug user; Effectiveness; Eligibility Determination; eligible participant; Enrollment; Environment; Expenditure; experience; Face; Federal Government; Feedback; Fees; Frequencies; Funding; Health; Health behavior change; Health Benefit; Human Resources; improved; Industry; Informed Consent; Injury; innovation; Intellectual Property; interest; intervention cost; Lawyers; Lead; Learning; Legal; Legal patent; Medical; meetings; Mental Health; Methods; Modeling; National Institute of Drug Abuse; new technology; off-patent; online registry; Opioid; opioid epidemic; Overdose; Participant; Patient Recruitments; Pharmacologic Substance; Phase; Pilot Projects; Prevention; Process; Public Health; Questionnaires; recruit; Recruitment Activity; Registries; Reporting; Research; Research Personnel; research study; response; screening; Services; Silicon; social; social stigma; Stigmatization; success; Surveys; System; Target Populations; Technology; technology development; technology validation; Testing; Time; time use; TimeLine; Translational Research; United States; usability; volunteer; web site; Writin
