Abstracts

Rationale: Attaining enrollment goals is critical for the success of any clinical research trial (CRT). Lasagna’s Law stated decades ago that “the incidence of patient availability sharply decreases when a clinical trial begins and returns to its original level as soon as the trial is completed.” While this may have originally been said tongue-in-cheek, realistic assessment of potential recruitment for CRT planning remains a challenge.Study design, site specific resources, and available patient population are all part of study feasibility assessment. As a pilot, we sought to investigate the impact of enrollment restrictions on recruitment for pharma-sponsored randomized controlled trials (RCTs) at the University of Rochester (UR) Level IV Epilepsy Center. Methods: As part of the recruitment effort for an IRB-approved pharma-sponsored RCT evaluating a common anti-epileptic medication (AED) in the Epilepsy Monitoring Unit (EMU) setting we prescreened adult (over 17 years of age) patients scheduled for EMU admission from June 2017 to April 2018. Patients’ electronic medical records were reviewed in light of pre-specified RCT inclusion and exclusion criteria.For this analysis exclusion criteria were divided into two categories: 1) common disease specific criteria: no prior seizure disorder diagnosis, prior diagnosis (or high likelihood) of non-epileptic psychogenic seizures, psychiatric condition that in the opinion of Investigator might compromise subjects’ ability to participate, use of illicit drugs, untreated sleep apnea, pregnant at admission, non-English speaking; and 2) study specific criteria: current use of the study drug as AED, allergy/intolerance to study drug or related AED, absence of well-defined clinical seizures or low likelihood of sufficient seizures to trigger study drug administration, and use of specifically prohibited medications in the EMU. Results: Over the specified time period 178 adult patients were scheduled for EMU admission. Patients scheduled during this period that canceled on the day of admission (8) were not included in the analysis.One hundred (60%) of all prescreened patients met disease specific exclusion criteria and 51 (30%) met study specific exclusion criteria, resulting in only 19 (10%) of patients study eligible. Sixteen (84%) out of 19 eligible patients were approached and 10 declined participation, resulting in 6 patients, or 32% of all eligible and just 3.4% of total EMU admissions, recruited for the study.  Conclusions: We found study exclusionary criteria to be a major limiting factor in enrollment into a typical inpatient RCT. Considering all exclusionary factors, total enrollment was a paltry less than 4% of EMU admissions over recruiting period. Given that almost 2/3 of the patients were ineligible due to commonly overlapping RCT exclusion criteria, these results establish a basis for calculations of realistic recruitment potential when considering feasibility of conducting any RCT. Further multi-center analysis needs to be performed to establish generalization of these findings. Funding: None