Reasons For Screen Failure Research Articles

Enrollment Yield and Reasons for Screen Failure in a Large Prehospital Stroke Trial.

The enrollment yield and reasons for screen failure in prehospital stroke trials have not been well delineated. The Field Administration of Stroke Therapy-Magnesium (FAST-MAG) trial identified patients for enrollment using a 2 stage screening process-paramedics in person followed by physician-investigators by cell phone. Outcomes of consecutive screening calls from paramedics to enrolling physician-investigators were prospectively recorded. From 2005 to 2012, 4458 phone calls were made by paramedics to physician-investigators, an average of 1 call per vehicle every 135.7 days. A total of 1700 (38.1%) calls resulted in enrollments. The rate of enrollment of stroke mimics was 3.9%. Among the 2758 patients not enrolled, 3140 reasons for screen failure were documented. The most common reasons for nonenrollment were >2 hours from last known well (17.2%), having a prestroke condition causing disability (16.1%), and absence of a consent provider (9.5%). Novel barriers for phone informed consent specific to the prehospital setting were infrequent, but included: cell phone connection difficulties (3.2%), patient being hard of hearing (1.4%), insufficient time to complete consent (1.3%), or severely dysarthric (1.3%). In this large, multicenter prehospital trial, nearly 40% of every calls from the field to physician-investigators resulted in trial enrollments. The most common reasons for nonenrollment were out of window last known well time, prestroke confounding medical condition, and absence of a consent provider. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00059332.

Profiles of screen-failures in phase 1 clinical trials.

e17518 Background: To be enrolled into a Phase I clinical trial (P1) patients have to fulfill inclusion criteria. Despite satisfying them at the time of informed consent form signature, a significant proportion of patients can eventually not receive the study drug and is consequently considered as screen-failure (SF). The objective of our study was to describe the frequency and reasons for SF, the profile of patients. Methods: All patients included in P1 at Gustave Roussy from 2008 to 2013 were reviewed retrospectively to identify SF cases. Patients' characteristics, tumor type and stage, experimental drug type and SF reason were analyzed. Reason for SF was classified into four groups: clinical cancer progression, P1 feasibility (promoter or investigator decision, patient’s consent withdrawal), chemistry out of protocol-specified range and relevant comorbidity. Results: Among 1,293 patients, 193 (15%) SF were identified: median age was 57 years (interquartile range (IQR) = [49-64]), 57% were men, 12% had ...

Screen failure in phase I HIV clinical trials in Soweto, South Africa: an opportunity for care

Background Reasons for screen failures are evaluated for three phase 1 HIV vaccine clinical trials recruiting healthy low-risk participants at the Perinatal HIV Research Unit: SAAVI102/HVTN073 and SAAVI103/HVTN086 (the first trials evaluating a Clade C vaccine, Novartis Subtype C gp140 with MF59 adjuvant boosting SAAVI DNA-C2 and SAAVI MVA-C vaccine) and IAVIB003/HVTN091 (Ad26 and Ad35 ENV vaccines). Recruitment strategies involved a pre-screening programme, clinics and community outreach.