Innovations In Clinical Neuroscience

Summit 2017

A peer-reviewed, evidence-based journal for clinicians in the field of neuroscience

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respondents motivated by training, 33 p ercent were willing to spend an hour or more training, and 34 percent said they'd spend 30 to 60 minutes training. For respondents motivated by other things, 24 percent would be willing to spend m ore than an hour training, and 32 percent said they'd spend 30 to 60 minutes training. Conclusion: Training was the number one factor chosen by respondents to motivate them to complete daily questionnaires, surpassing reminders, money, games, or any other motivators. Training motivates subjects to be adherent with daily diary completion in clinical trials, and these subjects are willing to spend time to be trained. PATIENT RECRUITMENT How to scale up recruitment in Alzheimer's disease clinical trials from 3 to 100 screens a month Presenters: Cajal M and Stanton S Affiliations: Bioclinica Research Network, formerly Compass Research, Orlando, FL, USA Background/Objective: With so many Alzheimer's disease (AD) and AD prevention clinical trials and numerous patients affected, sites need to scale up their recruitment from three screens a month to 100 screens a month consistently. Design: We combined a variety of recruitment approaches to assess which ones were most effective at generating high recruitment volumes. Recruitment approaches tested included use of digital media (Facebook, Studykik, Clinical Connection, and Trial Spark); print; TV; radio ads; direct outreach to patient database via mail, email or phone; physician partnerships; and community outreach. Results: Over four months of using those recruitment strategies in combinations, the results were as follow: 38 percent of screened patients originated from physicians' referrals, either from the investigator's private practice or from colleagues in Central Florida working with our community liaisons. Twenty-one percent came from direct community outreach (especially from physician's educational seminars), participation in health fairs, and caregiver s upport groups. Twenty-one percent came from engaging our own database of previous participants as well as subjects having expressed interest in the past. Lastly, 20 percent originated f rom more traditional marketing (i.e., print, radio, TV, and the use of digital media). Conclusion: In order to significantly scale up recruitment in AD studies, no patient engagement method should be neglected. Efforts should be made to provide information to the community as a whole, including patients, caregivers, and physicians, in order to raise awareness of AD and clinical trials. In the end, a volunteer's participation is directly linked to their understanding of clinical trials. Disclosures/funding: The authors are employees of Bioclinica Research Network, formerly Compass Research. Patient recruitment campaign strategies and effectiveness in a clinical trial of patients with opioid use disorder Presenters: Ramos J 1 , Miller M 2 , Carter D 1 , Farfel L 1 , and Martin W 1 Affiliations: 1 Alkermes, Inc. and 2 StudyKIK Objectives: Our aim is to present the results of a patient recruitment campaign (PRC) as well as methodologies utilized to recruit patients in a challenging trial of patients with opioid use disorder (OUD). Background: ALK6428-A301 was a Phase III study to evaluate the efficacy, safety, and tolerability of low doses of oral naltrexone used in conjunction with sublingual buprenorphine (BUP) for adults with opioid use disorder (OUD) prior to the first injection of VIVITROL® (naltrexone for extended-release injectable suspension). Recruitment of patients with OUD is a challenging and complex endeavor in a clinical trial setting. Additionally, concern of receiving placebo is often a major deterrent for clinical trial participation in this patient population. A unique challenge of this trial was a statistical requirement of a representative balance of patients currently using heroin or prescription (Rx) opioids. Given these factors, the present trial required the i mplementation of a recruitment strategy uniquely tailored to this patient population to ensure enrollment targets were met. Design: This 16-week trial required t hat the population (n=380) comprise approximately 65-percent heroin users and 35-percent Rx users. The trial consisted of three treatment arms that contained ascending oral naltrexone (or placebo) and descending BUP (or placebo). All subjects received an ancillary medication regimen as part of a seven-day outpatient detoxification with VIVITROL administration on Day 8. The recruitment strategy included a comprehensive PRC incorporating traditional advertising tactics (e.g., print, TV, and radio), and digital campaign (e.g., banner ads, Pandora, and StudyKik). A branded component of the PRC, "Crossroads," focused on Rx patients at risk for transitioning to heroin. Results: Of the 657 patients screened for trial participation, 505 (77%) were recruited from advertising and 264 of 380 (70%) randomized came from advertising. Approximately 60 percent of randomized heroin users and 80 percent of randomized Rx users came from advertising. Over the final four months of the trial, approximately 80 percent of randomizations came from PRC tactics. It is estimated that without the PRC, this trial would have taken an additional four years to enroll, while costing more than twice as much. Overall, no differences were noted in primary endpoint with regard to the patient source, i.e., coming from the PRC vs. non-PRC. Conclusion: The patient recruitment campaign implemented in the present trial of patients with OUD was effective and resulted in cost and time savings. No apparent differences were observed in key quality metrics of patients recruited from advertising vs. non- advertising sources. Patient recruitment campaigns in this patient population might be an effective way to reduce clinical trial time and cost without sacrificing the integrity of the trial data. Disclosures/funding: ALK6428-A301 was an Alkermes-sponsored clinical ICNS Innovations in Clinical Neuroscience • November–December 2017 • Volume 14 • Number 11–12 • Supplement S14

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