CenExel is proud to highlight the poster presented at the Annual International/Canadian Society of Addiction Medicine, November 2020, Virtual Meeting.
ABSTRACT
Introduction: The need to conduct clinical trials for the treatment of opioid use disorder (OUD) cannot be overemphasized, as 128 people die each day in the US from opioid overdose and this death toll has been increasing per year (CDC, 2020). However, one crucial aspect hindering trial conduct and data quality is poor subject retention, and research suggests OUD studies have significantly high dropouts (O’Connor et al., 2020). While no research could be located assessing OUD patients’ specific preferences on trial design and conduct strategies, including during the COVID19 pandemic, exploring these factors is arguably an essential step toward enhancing these participants’ study retention (Costello, 2016).
Methods: Eighty-two patients diagnosed with OUD and seeking an OUD clinical trial completed (before study screening) a 10-point Likert 45-item questionnaire on perspective of methodological, site operational, and COVID19 mitigation approaches that would motivate them to participate in an OUD trial.
Results: Highlighted preferences that strongly motivate participation included shorter visit durations, free transportation, knowing they are helping to bring new treatment to market, and obtaining mental health care. Surprisingly, no significant preferences were reported for inpatient vs outpatient studies or visit frequencies. Patients strongly preferred onsite than remote visits during COVID19. No significant demographic differences were found, except African-American patients significantly desired the Consent Form being explained before study participation as compared to Caucasian patients.
Conclusions: The poster will discuss how OUD patient reported preferences regarding trial design and site operations (particularly respective of the COVID19 pandemic) can positively influence subject retention.
INTRODUCTION
- The Opioid Use Disorder (OUD) pandemic is well documented. The OUD amassment has resulted in nearly 450,000 American deaths from 1999-2018 (CDC, 2011) and 128 people presently die per day from an overdose (CDC, 2020). Globally in 2016, 27 million people suffered from OUD (WHO, 2018), with OUD increasing 47% since 1990 (Deganhardt et al., 2018).
- The opioid crisis demands clinical trials focus on OUD treatments. However, issues related to OUD participant retention, a critical component to trial data quality, could not be located after a thorough review of the literature. Data on subject dropouts is essential because poor retention has several negative clinical trial implications, including longer study durations, costlier trials, lower likelihood of statistical power for both the study and the validity of the results, morale of study site staff, and potential termination of the trial which could bring less prospective interventions to those suffering from an OUD (Sullivan, 2004). What we do know about retention in this area solely comes from OUD related work, such as OUD treatment dropouts which has been shown to be significantly high at approximately 57% (O’Connor et al., 2020) and Gehling et al.’s (2011) 19 study meta-analysis of patients with chronic pain due to osteoarthritis which indicated that these participants have a significantly increased dropout rate.
- Understanding subjects’ clinical trial preferences across various trial factors is a fundamental step toward enhancing retention (Costello, 2016; Gul & Ali, 2010; Northrup et al., 2017; Page & Persch, 2013; Sullivan, 2004). Given that no data could be found specifically on these issues among OUD patients, the current investigation surveyed OUD patients seeking to enroll into an OUD clinical trial and their desire for several trial design and operational variables that would motivate them to participate in an OUD treatment clinical trial.
- Similar to the dearth of data on OUD patients’ clinical trial preferences, no empirical work could be found on participants’ clinical trial methodology propensities respective of the current COVID19 pandemic. However, these matters were routinely solicited by sponsors and CROs to research sites across the US during several industry meetings conducted since the onset of the pandemic ‘s profound industry impact in March 2020. As such, the current study assessed COVID19 related design scenario preferences as well from OUD patients.
METHODS
- This study was conducted from May-August, 2020 at an East coast US research site where OUD clinical trials were being conducted.
- Through the site’s database and advertisements, individuals who reported using an opioid substance and expressed interest in joining an OUD treatment clinical trial were psychiatrically evaluated by qualified clinicians through education and experience.
- Only patients diagnosed with primary OUD via the DSM-5 (APA, 2013) were included in the current data results.
- Before signing consent for any OUD clinical trial, the diagnosed OUD patients completed a seven-page Research Participant Preferences Survey (RPPS) which asked about their preferences on various research design and site operational matters on a 10-point Likert scale. Open ended questions were also queried. Age, gender, and race were also collected.
RESULTS
- Out of the 82 OUD patients who completed the RPPS, their demographics were:
- 49 males (60%)
- 33 females (40%)
- Mean age was 40 (range from 21-65)
- 37 identified as White (45%) Ø 36 African-American (44%)
- 7 Latino (17%)
- 1 Asian (.01%)
- 70 (85%) of the responders had never been in a clinical trial, while 8 (10%) had participated in only one trial. These data are understandable since the enrolling site OUD studies at the time the survey was being completed by patients needed to have current rather than previous opioid abusers. Current study data should be interpreted in this context and may present as a study limitation .
- Results of patient preferences on study design and site are shown in Table 1 with particular DISCUSSION points articulated inoperational matters the colored boxes respective of the data bar graph.
- Significant differences across variables are noted in green highlight.
Elan A. Cohen,1 Howard Hassman,1 David P. Walling,2 Vera M. Grindell,2 Katarzyna Wyka,3 Djouher Hough,1 Jaclyn M. Lobb,1 Ashok V. Joseph,1 Roberta R. Ball,1 Steven J. Glass,1 and Larry Ereshefsky1,4 Hassman
Research Institute, Science Division1; Collaborative Neuroscience Network2; The City University of New York, Graduate School of Public Health and Health Policy3; Retired Professor, The University of Texas4
