Clinical Trials and Surveys Corporation

Owings Mills, MD, United States

Clinical Trials and Surveys Corporation

Owings Mills, MD, United States
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Sazonov V.,Sharp Corporation | MacCubbin D.,Sharp Corporation | Sisk C.M.,Sharp Corporation | Canner P.L.,Clinical Trials and Surveys Corporation
International Journal of Clinical Practice | Year: 2013

Background: This post hoc analysis from the Coronary Drug Project (CDP) evaluated the effects of niacin vs. placebo on the incidence of new onset type 2 diabetes mellitus (T2DM) and cardiovascular event rates in patients with normal and impaired fasting glucose (IFG). Methods: The CDP was a randomised, placebo-controlled clinical trial of lipid-modifying agents in men with previous myocardial infarction. Normoglycaemia and IFG were defined as fasting plasma glucose (FPG) < 5.6 mmol/l and FPG ≥ 5.6 but < 7.0 mmol/l, respectively. New onset T2DM was defined by ≥ 1 of the following: clinical diagnosis of T2DM, use of an antihyperglycaemic therapy, or two FPG values ≥ 7.0 mmol/l. Results: The incidence of new onset T2DM was higher in patients with IFG (16.5%) compared with those with normoglycaemia (5.4%), and was slightly higher with niacin vs. placebo in both normoglycaemic (6.8% vs. 4.9%; p = 0.07) and IFG (19.8% vs. 15.2%; p = 0.05) patients. Consistent with previous analyses, the cardiovascular benefit of niacin was independent of baseline glycaemic status (normal, IFG, T2DM) and change in fasting glucose level from baseline to year 1. Conclusion: Despite a modest increase in risk of new onset T2DM with long-term niacin therapy, there is a potential cardiovascular benefit of niacin. Linked Comment: Weirzbicki. Int J Clin Pract 2013; 67: 294-6. © 2013 Blackwell Publishing Ltd.


Wang W.C.,St Jude Childrens Research Hospital | Oyeku S.O.,Montefiore Medical Center | Luo Z.,Clinical Trials and Surveys Corporation | Boulet S.L.,National Center for Chronic Disease Prevention and Health Promotion | And 5 more authors.
Pediatrics | Year: 2013

Background and objective: In the BABY HUG trial, young children with sickle cell anemia randomized to receive hydroxyurea had fewer episodes of pain, hospitalization, and transfusions. With anticipated broader use of hydroxyurea in this population, we sought to estimate medical costs of care in treated versus untreated children. Methods: The BABY HUG database was used to compare inpatient events in subjects receiving hydroxyurea with those receiving placebo. Unit costs were estimated from the 2009 MarketScan Multi-state Medicaid Database for children with sickle cell disease, aged 1 to 3 years. Inpatient costs were based on length of hospital stay, modified by the occurrence of acute chest syndrome, splenic sequestration, or transfusion. Outpatient expenses were based on the schedule required for BABY HUG and a "standard" schedule for 1- to 3-year-olds with sickle cell anemia. Results: There were 232 hospitalizations in the subjects receiving hydroxyurea and 324 in those on placebo; length of hospital stay was similar in the 2 groups. Estimated outpatient expenses were greater in those receiving hydroxyurea, but these were overshadowed by inpatient costs. The total estimated annual cost for those on hydroxyurea ($11 072) was 21% less than the cost of those on placebo ($13 962; P = .038). Conclusions: Savings on inpatient care resulted in a significantly lower overall estimated medical care cost for young children with sickle cell anemia who were receiving hydroxyurea compared with those receiving placebo. Because cost savings are likely to increase with age, these data provide additional support for broad use of hydroxyurea treatment in this population. © 2013 by the American Academy of Pediatrics.


Zemel B.S.,Children's Hospital of Philadelphia | Leonard M.B.,Children's Hospital of Philadelphia | Kelly A.,Children's Hospital of Philadelphia | Lappe J.M.,Creighton University | And 8 more authors.
Journal of Clinical Endocrinology and Metabolism | Year: 2010

Context: In children, bone mineral content (BMC) and bone mineral density (BMD) measurements by dual-energy x-ray absorptiometry (DXA) are affected by height status. No consensus exists on how to adjust BMC or BMD (BMC/BMD) measurements for short or tall stature. Objective: The aim of this study was to compare various methods to adjust BMC/BMD for height in healthy children. Design: Data from the Bone Mineral Density in Childhood Study (BMDCS) were used to develop adjustment methods that were validated using an independent cross-sectional sample of healthy children from the Reference Data Project (RDP). Setting: We conducted the study in five clinical centers in the United States. Participants: We included 1546 BMDCS and 650 RDP participants (7 to 17 yr of age, 50% female). Intervention: No interventions were used. Main Outcome Measures:Wemeasured spine and whole body (WB)BMCandBMDZ-scores for age (BMC/BMD age), height age(BMC/BMD height age), height(BMC height), bone mineral apparent density (BMAD age), and height-for-age Z-score (HAZ) (BMC/BMD haz). Results: Spine and WB BMC/BMD ageZ and BMAD ageZ were positively (P < 0.005; r = 0.11 to 0.64) associated with HAZ. Spine BMD haz and BMC hazZ were not associated with HAZ; WB BMC hazZ was modestly associated with HAZ (r = 0.14; P = 0.0003). All other adjustment methods were negatively associated with HAZ (P < 0.005; r = -0.20 to -0.34). The deviation between adjusted and BMC/BMD age Z-scores was associated with age for most measures (P < 0.005) except for BMC/BMD haz. Conclusions: Most methods to adjustBMC/BMDZ-scores for height were biased by age and/or HAZ. Adjustments using HAZ were least biased relative to HAZ and age and can be used to evaluate the effect of short or tall stature on BMC/BMD Z-scores. Copyright © 2010 by The Endocrine Society.


Rana S.,Howard University | Houston P.E.,Howard University | Wang W.C.,St Jude Childrens Research Hospital | Iyer R.V.,University of Mississippi Medical Center | And 6 more authors.
Pediatrics | Year: 2014

BACKGROUND: Growth impairment is a known complication of sickle cell disease. Effects of hydroxyurea (HU) on growth in very young children are not known.METHODS: Height, weight, BMI, and head circumference (HC) were compared with World Health Organization (WHO) standards in BABY HUG, a multicenter, randomized, double-blinded, placebo-controlled 2-year clinical trial of HU in 193 children 9 to 18 months of age. Anthropometric data were closely monitored and converted to z scores by using WHO standardized algorithms for descriptive analyses. The treatment and placebo groups were compared longitudinally by using a mixed model analysis.RESULTS: At entry, the z scores of BABY HUG children were higher than WHO norms. After 2 years of HU or placebo treatment, there were no significant differences between the groups, except for the mean HC z scores at study exit (HU: +0.8 versus placebo: +1.0, P = .05). Baseline z scores were the best predictors of z scores at study exit. The absolute neutrophil count, absolute reticulocyte count, and total white blood cell count had significant negative correlations with growth measures.CONCLUSIONS: Both groups had normal or near normal anthropometric measures during the study. The HC z scores at study entry and exit were slightly greater than WHO norms. Higher baseline white blood cell count, absolute reticulocyte count, and absolute neutrophil count were associated with poorer growth. The significance of the slightly lower HC in the treatment group at study exit is not clear. Trends toward normalization of weight and height and effects on HC will be monitored in ongoing BABY HUG follow-up studies.


Sheehan V.A.,Baylor College of Medicine | Luo Z.,Clinical Trials and Surveys Corporation | Flanagan J.M.,Baylor College of Medicine | Howard T.A.,Baylor College of Medicine | And 4 more authors.
American Journal of Hematology | Year: 2013

The recently completed BABY HUG trial investigated the safety and efficacy of hydroxyurea in infants with sickle cell anemia (SCA). To investigate the effects of known genetic modifiers, genomic DNA on 190 randomized subjects were analyzed for alpha thalassemia, beta-globin haplotype, polymorphisms affecting endogenous fetal hemoglobin (HbF) levels (XmnI, BCL11A, and HBS1L-MYB), UGT1A1 promoter polymorphisms, and the common G6PD A- mutation. At study entry, infants with alpha thalassemia trait had significantly lower mean corpuscular volume, total bilirubin, and absolute reticulocyte count. Beta-globin haplotypes associated with milder disease had significantly higher hemoglobin and %HbF. BCL11A and XmnI polymorphisms had significant effects on baseline HbF, while UGT1A1 promoter polymorphisms significantly influenced baseline serum bilirubin. At study exit, subjects randomized to placebo still exhibited laboratory effects of alpha thalassemia and other modifiers, while those assigned hydroxyurea had treatment effects that exceeded most genetic influences. The pain phenotype was influenced by HbF modifiers in both treatment groups. These data document that genetic polymorphisms do modify laboratory and clinical phenotypes even in very young patients with SCA. The hydroxyurea effects are more potent, however, indicating that treatment criteria should not be limited to certain genetic subsets, and supporting the use of hydroxyurea for all young patients with SCA. © 2013 Wiley Periodicals, Inc.


Thornburg C.D.,Duke University | Files B.A.,Emory University | Luo Z.,Clinical Trials and Surveys Corporation | Miller S.T.,New York University | And 8 more authors.
Blood | Year: 2012

The Pediatric Hydroxyurea Phase 3 Clinical Trial (BABY HUG) was a phase 3 multicenter, randomized, double-blind, placebocontrolled clinical trial of hydroxyurea in infants (beginning at 9-18 months of age) with sickle cell anemia. An important secondary objective of this study was to compare clinical events between the hydroxyurea and placebo groups. One hundred and ninetythree subjects were randomized to hydroxyurea (20 mg/kg/d) or placebo; there were 374 patient-years of on-study observation. Hydroxyurea was associated with statistically significantly lower rates of initial and recurrent episodes of pain, dactylitis, acute chest syndrome, and hospitalization; even infants who were asymptomatic at enrollment had less dactylitis as well as fewer hospitalizations and transfusions if treated with hydroxyurea. Despite expected mild myelosuppression, hydroxyurea was not associated with an increased risk of bacteremia or serious infection. These data provide important safety and efficacy information for clinicians considering hydroxyurea therapy for very young children with sickle cell anemia. This clinical trial is registered with the National Institutes of Health (NCT00006400, www.clinicaltrials. gov). © 2012 by The American Society of Hematology.


Rausch M.,North Shore University Hospital | Lorch S.,Children's Hospital of Philadelphia | Chung K.,University of Southern California | Frederick M.,Clinical Trials and Surveys Corporation | And 2 more authors.
Fertility and Sterility | Year: 2012

Objective: To determine the cost-effectiveness of medical and surgical management of early pregnancy loss. Design: Analyses of cost, effectiveness, and incremental cost-effectiveness ratios and utilities of a multicenter trial with 652 women with first-trimester pregnancy failure randomized to medical or surgical management. Setting: Analysis of data from a multicenter trial. Patient(s): Secondary analysis of a multicenter trial. Intervention(s): Cost-effectiveness analysis. Main Outcome Measure(s): Cost and effectiveness of competing treatment strategies. Result(s): Cost analysis of treatment demonstrates an increased cost of US$336 for 13% increased efficacy of surgical management. This analysis was sensitive to the probability of an extra office visit, the cost of the visit, and the probability of success. When the surgical arm is divided into outpatient manual vacuum aspiration (MVA) versus inpatient electric vacuum aspiration (EVA), there is an increased cost of $745 for EVA but a decreased cost of $202 for MVA compared with medical management. In general, MVA was found to be more cost-effective than medical management. For treatment of incomplete or inevitable abortion, medical management was found to be less costly and more efficacious. Utilities studies demonstrated that a patient would need to prefer surgery 14% less than medication for its treatment efficacy to be outweighed by the desire to avoid surgery. Conclusion(s): Surgical or medical management of early pregnancy failure can be cost effective, depending on the circumstances. Surgery is cost effective and more efficacious when performed in an outpatient setting. For incomplete or inevitable abortion, medical management is cost effective and more efficacious. © 2012 American Society for Reproductive Medicine, Published by Elsevier Inc.


Paredes R.,Harvard University | Paredes R.,Autonomous University of Barcelona | Cheng I.,Clinical Trials and Surveys Corporation | Kuritzkes D.R.,Harvard University | Tuomala R.E.,Harvard University
AIDS | Year: 2010

Background: Pregnancy-limited antiretroviral therapy (PLAT) drastically reduces HIV-1 transmission to the newborn, but may select for antiretroviral drug resistance mutations in mothers. Methods: We evaluated antiretroviral- naive, HIV-1-infected pregnant women who received PLAT between 1998 and 2005, and had 2-month or 6-month postpartum plasma samples available with HIV-1 RNA levels more than 500 copies/ml. Postpartum drug resistance mutation rates were assessed blindly using population sequencing and allele-specific PCR (ASPCR) of the M184V, K103N and D30N mutations. Factors associated with selection of drug resistance mutations were investigated. Results: One hundred and forty-six women were included. All women received zidovudine and lamivudine during pregnancy; 76% also received nelfinavir and 8.2% nevirapine. Resistance data were available from 114 women (78%). Postpartum rates of single-class, dual-class, and triple-class resistance were, respectively, 43, 6.1 and 0% (63.2, 10.5 and 1.7% by ASPCR). In women receiving dual or triple PLAT, respectively, postpartum M184V/I rates were 65% (95% by ASPCR) and 28.7% (51.6% by ASPCR), respectively (P < 0.01). Postpartum nonnucleoside reverse transcriptase inhibitor (NNRTI) resistance rates among women receiving nevirapine were 25% for K103N (37.5% by ASPCR) and 12.5% for Y188C. Protease inhibitor resistance rates in women receiving nelfinavir were 1.1% for D30N (1.1% by ASPCR) and 1.1% for L90M. Dual versus triple PLAT and prolonged zidovudine exposure were associated with selection of M184V. Nevirapine use and length of zidovudine and lamivudine exposure were associated with selection of K103N. Conclusion: PLAT is associated with frequent selection of resistance to drugs with low-genetic barrier. Triple-drug PLAT decreases the odds for M184V selection. Routine postpartum genotypic resistance testing may be useful to guide future treatment decisions in mothers. © 2010 Wolters Kluwer Health | Lippincott Williams & Wilkins.


Rogers Z.R.,University of Texas Southwestern Medical Center | Wang W.C.,St Jude Childrens Research Hospital | Luo Z.,Clinical Trials and Surveys Corporation | Iyer R.V.,University of Mississippi Medical Center | And 9 more authors.
Blood | Year: 2011

We evaluated spleen function in 193 children with sickle cell anemia 8 to 18 months of age by 99mTc sulfur-colloid liver-spleen scan and correlated results with clinical and laboratory parameters, including 2 splenic biomarkers: pitted cell counts (PIT) and quantitative Howell-Jolly bodies (HJB) enumerated by flow cytometry. Loss of splenic function began before 12 months of age in 86% of infants in association with lower total or fetal hemoglobin and higher white blood cell or reticulocyte counts, reinforcing the need for early diagnosis and diligent preventive care. PIT and HJB correlated well with each other and liver-spleen scan results. Previously described biomarker threshold values did define patients with abnormal splenic function, but our data suggest that normal spleen function is better predicted by PIT of ≤ 1.2% or HJB ≤ 55/106 red blood cells and absent function by PIT ≥ 4.5% or HJB ≥ 665/106. HJB is methodologically advantageous compared with PIT, but both are valid biomarkers of splenic function. This trial was registered at www.clinicaltrials.gov as #NCT00006400. © 2011 by The American Society of Hematology.


Armstrong F.D.,University of Miami | Elkin T.D.,University of Mississippi | Brown R.C.,Emory University | Glass P.,Childrens National Medical Center | And 5 more authors.
Pediatrics | Year: 2013

Neurocognitive impairment occurs in children and adults with sickle cell anemia, but little is known about neurodevelopment in very young children. We examined the neurodevelopmental status of infants participating in the Pediatric Hydroxyurea Phase III Clinical Trial (Baby Hug) to determine relationships with age, cerebral blood flow velocity, and hemoglobin concentration. METHODS: Standardized measures of infant neurodevelopment were administered to 193 infants with hemoglobin SS or hemoglobin S-b0 thalassemia between 7 and 18 months of age at the time of their baseline evaluation. Associations between neurodevelopmental scores and age, family income, parent education, hemoglobin concentration, and transcranial Doppler velocity were examined. RESULTS: Mean functioning on the baseline neurodevelopment scales was in the average range. There were no mental development scores ,70 (impaired); 22 children had scores in the clinically significant range, 11 with impaired psychomotor scores and 11 with problematic behavior rating scores. Significantly poorer performance was observed with older age at baseline. Behavior rating scores were an average of 2.82 percentile points lower per month of age, with similar patterns observed with parent report using adaptive behavior scales. Parent-reported functional abilities and hemoglobin were negatively associated with higher transcranial Doppler velocities. Copyright © 2013 by the American Academy of Pediatrics.

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