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Industry Sponsored Study Recruitment Highlights

Pneumonia Vaccine Study 2008
This vaccine study evaluated the safety and effectiveness of an investigational pneumonia vaccine when given with the flu vaccine.
Population 50- to 59-Year-Olds
Sites Cincinnati Children's was the number one enrolling site of the 34 participating sites.
Enrollment Time 10/ 07 to 3/08
Recruitment Results As the top recruiting site, Cincinnati Children's enrolled 90 participants (40 more than the original goal of 50 participants).  The overall goal for all 34 test sites was 1100 participants.  A major recruitment challenge was that the sponsor had to start the study late in October after many potential participants had already received flu vaccines.  This made recruitment of 50- to 59-year-olds more challenging..
Herpes Simplex Virus Medication, 2006
Designed to investigate the safety and PK of an adult-approved medication in children, this study involved an extended outpatient stay, multiple blood draws, a follow-up visit and call.
Population 1- to 2-year-olds with active, latent or suspected HSV.
Sites Cincinnati Children's was one of 9 sites working towards an overall goal of 26.
Enrollment Time 2/06 - 5/06
Recruitment Results Cincinnati Children's surpassed its goal of 2 by screening 4 patients and enrolling 3 in the study. Recruitment success was met using GroupWise, Cincinnati Children's internal e-mail system.
Molluscum Contagiosum, 2004-2006
This pediatric PK study evaluated an adult, FDA-approved medication for Molluscum Contagiosum.
Population Children 2 to 12 years old with extensive Molluscum Contagiosum (10% of BSA).
Sites 5 sites participated in reaching an enrollment goal of 20. Cincinnati Children's met its goal of 6.
Enrollment Time 6/04 - 3/06
Recruitment Results With concern over age distribution, the sponsor petitioned the FDA to allow approximately equal age distribution. Cincinnati Children's enrolled a 2-year-old and a 9-year-old, providing the sponsor with the equal age distribution they were seeking, thus eliminating the need for the FDA petition.
Weight Reduction Medication, 2002-2005
This study evaluated the efficacy of a medication on reducing weight gained while using atypical antipsychotic medications.
Population 10- to 17-year-olds using atypicals (Risperdal, Seroquel, Zyprexia) and gaining 10.
Sites Cincinnati Children's Hospital Medical Center.
Enrollment Time 1/02 - 4/05
Recruitment Results After an initial period of low recruitment results (3), a reevaluation of recruiting efforts led to the enrollment of 37 subjects in the next year and reaching the enrollment goal of 40.
Echocardiogram, 2004
The major goal of this study was to establish serial normative data ranges of echocardiograms in healthy children to be used in safety assessments for future vaccine trials.
Population Healthy 2- to 14-year-olds.
Sites 9 sites participated in the study with a goal to recruit 320 subjects.
Enrollment Time 6/04 - 9/04
Recruitment Results Cincinnati Children's goal of 20 was exceeded to reach a total of 50 subjects. Cincinnati Children's ranked first in recruitment among the 9 sites involved in the study. In addition, Cincinnati Children's was the leading recruiter of African-American subjects.
RSV Medication in Neonates, 2004
This Phase III RSV (respiratory syncytial virus) comparison study between an approved medication and a new medication.
Population Preterm infants less than 35 weeks gestation and less than 6 months old. Also includes infants with chronic lung disease, 24 months old and younger.
Sites 124 sites participated in the study throughout the United States and Canada with a goal to enroll 2,200 subjects.
Enrollment Time 11/1/04 - 12/5/04
Recruitment Results Cincinnati Children's original goal, 12 subjects, was exceeded to reach 27 subjects (a 225 percent increase). Cincinnati Children's was rated first in recruitment of 124 test sites in the US and Canada.
Flu Vaccine for 65 and Older Adults, 2003
Population Healthy subjects 65 and older.
Sites The study began with three sites and was reduced to two because the flu had already begun in one of the site's recruitment areas. Cincinnati Children's was added last as a site.
Enrollment Time 3 1/2 weeks, 10/03 - 11/03
Recruitment Results The recruitment goal for all sites was 320 subjects. Cincinnati Children's quickly recruited its initial goal of 160 subjects and then worked with the sponsor to raise the goal and meet it a second time by recruiting a majority of the 175 study subjects.
Staphylococcus Infection Prevention Medication, 2003
Population Infant subjects had to be 4 to 5 days post birth (500 to 1250 gram babies). Many of the babies were premature and ill because of low birth weight. Parents were reluctant to have their sick infants participate in a clinical study.
Sites Cincinnati Children's ranked 17 out of 47 participating test sites.
Enrollment Time 3/03 - 10/03
Recruitment Results The goal for our site was 12 babies. That goal was exceeded to enroll 15 subjects.
Nutrition, 2002-2003
The purpose of this study was to compare two new cow's milk-based formulas for toddlers. The study included five visits and four stool collections.
Population Healthy children 12 to 34 months old. A total of 403 subjects were enrolled from all sites.
Sites Cincinnati Children's was one of 14 research sites that participated in the study.
Enrollment Time 8/02 - 3/03
Recruitment Results Of the 14 participating sites, Cincinnati Children's was one of the first to reach their enrollment goal of 36 subjects or 25 percent of the total 142 subjects who completed the study.
Adolescents with Depression, 2001-2003
This study compared how effective different treatments and combinations of treatments are for dealing with depression in teenagers.
Population Children 12 to 17 years old with depression.
Sites Our site started 1 ½ years later than the other 12 centers and finished 4 out of 13.
Enrollment Time 12/01 - 7/03
Recruitment Results The original goal for our site was 10 subjects. Two hundred five subjects were screened for the study and 42 were enrolled. (The recruitment goal for all 13 centers collectively was 432.)
Otitis Media, 2001-2002
The study demonstrated that antibiotic use can be decreased with acute otitis media by using pain control medication and prescribing a "safety net" prescription for antibiotics to be filled if symptoms do not resolve after 48 hours.
Population 1- to 12-year-olds with acute otitis media.
Sites 11 pediatric offices of the Cincinnati Pediatric Research Group (CPRG), a Greater Cincinnati practice-based research network.
Enrollment Time 11 months
Recruitment Results 179 children with acute otitis media were enrolled from a goal of 200 subjects. Only four families declined to participate when asked.