Institute for Clinical Research

North Miami, FL, United States

Institute for Clinical Research

North Miami, FL, United States

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News Article | November 14, 2016
Site: www.eurekalert.org

[BOSTON, Mass. - November 14, 2016] The Baim Institute has announced that patient enrollment into the international Phase IIIb RE-DUAL PCI™ study is complete. The study evaluates the safety and efficacy of dabigatran etexilate in atrial fibrillation (AF) patients undergoing a percutaneous coronary intervention (PCI) with stent placement. This is the first time that two dosages of a non-vitamin K antagonist oral anticoagulant (NOAC) already approved for stroke prevention in AF are evaluated in a dual versus triple antithrombotic regimen after PCI. "Up to 30% of AF patients may have coronary artery disease and require PCI with stenting, yet to date only limited data exists on the use of the NOACs during this procedure," said Dr. Christopher Cannon, RE-DUAL PCI™ Lead Investigator and Executive Director, Cardiometabolic Trials, Baim Institute for Clinical Research, who is a cardiologist at Brigham and Women's Hospital in Boston and a Professor of Medicine, Harvard Medical School. "The RE-DUAL PCI™ study will provide new insights into antithrombotic treatment approaches in AF patients requiring PCI. "We expect the results to be highly clinically relevant for practicing physicians who treat patients such as these in routine care, as the study uses the two dabigatran doses already internationally approved for stroke risk reduction in AF," said Dr. Cannon. The results of the RE-DUAL PCI study are expected during the second half of 2017. The study is sponsored by Boehringer-Ingelheim. 1. Clinicaltrials.gov. Evaluation of Dual Therapy With Dabigatran vs. Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting (REDUAL-PCI). https:/ Last accessed November 2016. 2. Cannon C.P. et al. Design and Rationale of the RE-DUAL PCI Trial: A Prospective, Randomized, Phase 3b Study Comparing the Safety and Efficacy of Dual Antithrombotic Therapy With Dabigatran Etexilate Versus Warfarin Triple Therapy in Patients With Nonvalvular Atrial Fibrillation Who Have Undergone Percutaneous Coronary Intervention With Stenting. Clin Cardiol. 2016;39(10):555-564. Available at http://onlinelibrary. About The Baim Institute for Clinical Research The Baim Institute for Clinical Research (formerly known as Harvard Clinical Research Institute) is a leading, not-for-profit academic research organization that delivers insight, innovation and leadership in today's dynamic research environment. The Baim Institute collaborates with some of the world's most highly respected researchers from renowned institutions to help advance health and quality of life around the world. Since 1993, we have worked on over 450 clinical trials in North America, Europe and Asia. The Baim Institute is based in Boston. More information is at http://www. .


Named for Co-Founder and Interventional Cardiology Pioneer, Donald Baim, MD, to Honor his Passion, Insight, Innovation and Leadership; Change Reflects Desire for Greater Institutional Diversity, Expansion of Affiliations BOSTON, MA--(Marketwired - October 27, 2016) - The Harvard Clinical Research Institute (HCRI) announced today that it will change its name to the Baim Institute for Clinical Research (Baim Institute), as a reflection of its desire to further expand and diversify its faculty and institutional affiliations. Baim Institute will remain one of the world's most trusted not-for-profit academic research organizations. The new name pays tribute to Dr. Donald S. Baim, a visionary in the field of interventional cardiology, who was a founder of the organization in 1993 and a primary investigator and chief advisor through 2005. Dr. Baim died in 2009 at age 60. "Don dedicated his career to bringing innovative medical technologies forward, and cared deeply about the effective use of new therapeutics," said Laura Mauri, MD, MSc, Professor of Medicine, Harvard Medical School, Physician at the Brigham and Women's Hospital, and Chief Scientific Advisor of the Baim Institute. "He was an inspiration to generations of physician leaders for his ability to couple scientific thought with an unceasing commitment to improve patient care. He embodies the principles on which our Institute was founded and continues to grow." "Dr. Baim's impact is reflected in the Baim Institute's commitment to insight, innovation and leadership in the pursuit of evidence-based medicine that improves lives," said Don Cutlip, MD, Professor of Medicine, Harvard Medical School, Chief, Interventional Cardiology, Cardiac Catheterization Laboratory, Beth Israel Deaconess Medical Center, and Executive Director Clinical Investigations, Baim Institute. "We are fortunate to have had one of the most influential cardiology researchers as our co-founder and mentor." The organization was founded in 1993 as part of Beth Israel Hospital (currently the Beth Israel Deaconess Medical Center), and named the Cardiovascular Data Analysis Center (CDAC). Reflecting CDAC's expanded affiliations with other Harvard teaching hospitals, the organization took the name HCRI in 2000, becoming an independent not-for-profit. The network of institutions collaborating with HCRI grew over the last decade to include Boston University, Brigham and Women's Hospital, Lahey Hospital and Medical Center, and Massachusetts General Hospital. Now the Baim Institute is well-positioned to expand collaborations even further. "The Baim Institute provides a platform for us to build on the values that got us to where we are today," said Spencer Goldsmith, President, Baim Institute. "We will continue to expand our partnerships in ways that will deepen our commitment to advancing human health through creativity in clinical trial design and nimble operations." "The Baim Institute will continue to be a leading academic research organization, guided by our faculty and staff, continuing to serve the needs of research sponsors worldwide with the capabilities we have developed over the past 23 years," said Mr. Goldsmith. About the Baim Institute for Clinical Research The Baim Institute for Clinical Research is a leading, not-for-profit academic research organization that delivers insight, innovation and leadership in today's dynamic research environment. The Baim Institute collaborates with some of the world's most highly respected researchers from renowned institutions to help advance health and quality of life around the world. The Baim Institute has gained notoriety for the design and execution of clinical trials for first-in-class medical devices. Examples of such include trials for the first approved drug-eluting stent, and the first approved transcatheter mitral valve repair device. In addition, we recently sponsored and completed the DAPT study, a large, FDA-mandated study that enrolled over 25,000 subjects, evaluating the use of dual antiplatelet therapy after stent implantation. Since 1993, we have worked on over 450 clinical trials in North America, Europe and Asia. The Baim Institute is based in Boston. More information is at www.BaimInstitute.org.


The Baim Institute has announced that patient enrollment into the international Phase IIIb RE-DUAL PCI™ study is complete. The study evaluates the safety and efficacy of dabigatran etexilate in atrial fibrillation (AF) patients undergoing a percutaneous coronary intervention (PCI) with stent placement. This is the first time that two dosages of a non-vitamin K antagonist oral anticoagulant (NOAC) already approved for stroke prevention in AF are evaluated in a dual versus triple antithrombotic regimen after PCI. "Up to 30% of AF patients may have coronary artery disease and require PCI with stenting, yet to date only limited data exists on the use of the NOACs during this procedure," said Dr. Christopher Cannon, RE-DUAL PCI™ Lead Investigator and Executive Director, Cardiometabolic Trials, Baim Institute for Clinical Research, who is a cardiologist at Brigham and Women's Hospital in Boston and a Professor of Medicine, Harvard Medical School. "The RE-DUAL PCI™ study will provide new insights into antithrombotic treatment approaches in AF patients requiring PCI. "We expect the results to be highly clinically relevant for practicing physicians who treat patients such as these in routine care, as the study uses the two dabigatran doses already internationally approved for stroke risk reduction in AF," said Dr. Cannon. The results of the RE-DUAL PCI study are expected during the second half of 2017. The study is sponsored by Boehringer-Ingelheim. About The Baim Institute for Clinical Research The Baim Institute for Clinical Research (formerly known as Harvard Clinical Research Institute) is a leading, not-for-profit academic research organization that delivers insight, innovation and leadership in today's dynamic research environment. The Baim Institute collaborates with some of the world's most highly respected researchers from renowned institutions to help advance health and quality of life around the world. Since 1993, we have worked on over 450 clinical trials in North America, Europe and Asia. The Baim Institute is based in Boston. More information is at www.BaimInstitute.org.


Kang H.K.,Institute for Clinical Research | Bullman T.A.,Health-U | Smolenski D.J.,U.S. Army | Skopp N.A.,U.S. Army | And 2 more authors.
Annals of Epidemiology | Year: 2015

Purpose: We conducted a retrospective cohort mortality study to determine the postservice suicide risk of recent wartime veterans comparing them with the US general population as well as comparing deployed veterans to nondeployed veterans. Methods: Veterans were identified from the Defense Manpower Data Center records, and deployment to Iraq or Afghanistan war zone was determined from the Contingency Tracking System. Vital status of 317,581 deployed and 964,493 nondeployed veterans was followed from the time of discharge to December 31, 2009. Underlying causes of death were obtained from the National Death Index Plus. Results: Based on 9353 deaths (deployed, 1650; nondeployed, 7703), of which 1868 were suicide deaths (351; 1517), both veteran cohorts had 24% to 25% lower mortality risk from all causes combined but had 41% to 61% higher risk of suicide relative to the US general population. However, the suicide risk was not associated with a history of deployment to the war zone. After controlling for age, sex, race, marital status, branch of service, and rank, deployed veterans showed a lower risk of suicide compared with nondeployed veterans (hazard ratio, 0.84; 95% confidence interval, 0.75-0.95). Multiple deployments were not associated with the excess suicide risk among deployed veterans (hazard ratio, 1.00; 95% confidence interval, 0.79-1.28). Conclusions: Veterans exhibit significantly higher suicide risk compared with the US general population. However, deployment to the Iraq or Afghanistan war, by itself, was not associated with the excess suicide risk. © 2015.


Jain R.,R D Clinical Research Inc | Jain R.,Texas Tech University | Segal S.,Institute for Clinical Research | Kollins S.H.,Duke University | Khayrallah M.,Neuronex
Journal of the American Academy of Child and Adolescent Psychiatry | Year: 2011

Objective This study examined the efficacy and safety of clonidine hydrochloride extended-release tablets (CLON-XR) in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). Method This 8-week, placebo-controlled, fixed-dose trial, including 3 weeks of dose escalation, of patients 6 to 17 years old with ADHD evaluated the efficacy and safety of CLON-XR 0.2 mg/day or CLON-XR 0.4 mg/day versus placebo in three separate treatment arms. Primary endpoint was mean change in ADHD Rating ScaleIV (ADHD-RS-IV) total score from baseline to week 5 versus placebo using a last observation carried forward method. Secondary endpoints were improvement in ADHD-RS-IV inattention and hyperactivity/impulsivity subscales, Conners Parent Rating ScaleRevised: Long Form, Clinical Global Impression of Severity, Clinical Global Impression of Improvement, and Parent Global Assessment from baseline to week 5. Results Patients (N = 236) were randomized to receive placebo (n = 78), CLON-XR 0.2 mg/day (n = 78), or CLON-XR 0.4 mg/day (n = 80). Improvement from baseline in ADHD-RS-IV total score was significantly greater in both CLON-XR groups versus placebo at week 5. A significant improvement in ADHD-RS-IV total score occurred between groups as soon as week 2 and was maintained throughout the treatment period. In addition, improvement in ADHD-RS-IV inattention and hyperactivity/impulsivity subscales, Conners Parent Rating ScaleRevised: Long Form, Clinical Global Impression of Improvement, Clinical Global Impression of Severity, and Parent Global Assessment, occurred in both treatment groups versus placebo. The most common treatment-emergent adverse event was mild-to-moderate somnolence. Changes on electrocardiogram were minor and reflected the known pharmacology of clonidine. Conclusions Clonidine hydrochloride extended-release tablets were generally well tolerated by patients in the study and significantly improved ADHD symptoms in this pediatric population. Clinical trials registry informationStudy Evaluating the Safety and Efficacy of Clonicel to Treat Children and Adolescents with Attention Deficit Hyperactivity Disorder (ADHD), URL: http://www.clinicaltrials.gov, unique identifier: NCT00556959. © 2011 American Academy of Child and Adolescent Psychiatry.


Genberg B.L.,Brown University | Lee Y.,Brown University | Rogers W.H.,Institute for Clinical Research | Willey C.,University of Rhode Island | Wilson I.B.,Brown University
AIDS Patient Care and STDs | Year: 2013

Providers do not predict reliably which of their HIV-positive patients are having difficulty adhering to antiretroviral therapy (ART). The transtheoretical, or stages of change model, may be a useful tool to help providers identify patients who are having difficulty with ART adherence. The objective of the current study was to determine the relationship between stages of change and ART adherence among patients who were actively taking ART. Data from a randomized trial of a provider-focused intervention were used to examine the relationship between the stages of change and adherence, measured using electronic monitoring devices in the 30 days following the stages of change assessment. Individuals were eligible for inclusion if they were taking ART and had detectable plasma viral load (HIV-RNA). Repeated measures analysis of covariance was used to determine the impact of stages of change on adherence after controlling for potential confounders. The sample of 137 participants was 22% female, 48% white, 28% African-American, with a mean age of 42 years. Fifty-eight percent reported sex with a man as an HIV risk factor, while 13% reported sex with a woman, 14% reported injecting drugs and 15% reported other risk factors. In adjusted models, those in earlier stages of change (i.e., contemplation and preparation) had significantly lower adherence (-9.8%, p=0.04) compared to those in the action and maintenance phases. No demographic characteristics predicted adherence. The stages of change model may function as a screening tool for clinicians to discover patients at-risk of lower adherence. © 2013, Mary Ann Liebert, Inc.


Kondo M.,University of Tsukuba | Hoshi S.-L.,University of Tsukuba | Yamanaka T.,Institute for Clinical Research | Ishiguro H.,Kyoto University | Toi M.,Kyoto University
Breast Cancer Research and Treatment | Year: 2011

The 21-gene signature is validated as a good predictor of recurrence for lymph node-negative/positive, hormone receptor-positive, early-stage breast cancer in Japanese patient population. This study evaluates the cost-effectiveness of two scenarios designed to include the assay into Japan's social health insurance benefit package: one for LN-, ER+, ESBC and another for LN-/+, ER+, ESBC. An economic decision tree and Markov model under Japan's health system from the societal perspective is constructed with new evidence from the Japanese validation study. Incremental cost-effectiveness ratios are estimated as ¥384,828 (US$3,848) per QALY for the indication for LN- scenario and ¥568,533 (US$5,685) per QALY for the indication for LN-/+ scenario. Both are not more than the suggested social willingness-to-pay for one QALY gain from an innovative medical intervention in Japan, ¥5,000,000/QALY (US$50,000/QALY). Sensitivity analyses show that this result is plausibly robust, since ICERs do not exceed the threshold by various changes of assumptions made and values employed. In conclusion, the inclusion of the assay in Japan's social health insurance benefit package for not only LN- diseases but also LN+ diseases is cost-effective. Such a decision can be justifiable as an efficient use of finite resources for health care. © 2010 Springer Science+Business Media, LLC.


Kawanami T.,Institute for Clinical Research | Takiguchi S.,Institute for Clinical Research | Ikeda N.,Kyushu University | Funakoshi A.,International University of Health and Welfare
Oncology Reports | Year: 2012

Pancreatic cancer is a disease with a dismal prognosis and treatment options are limited. This study investigated the interaction of gemcitabine with R1507 and/or metformin and the induction of an inhibitor of apoptosis protein by this combination. Pancreatic cancer cells were treated with gemcitabine, R1507 and metformin alone or in combination. The effects of treatments were evaluated for cell proliferation, apoptosis, and the expression of genes related to inhibition of apoptosis and chemotherapy resistance. Combination of gemcitabine with R1507 and/or metformin additively interacted with the inhibition of cell proliferation in human pancreatic ductal adenocarcinoma cell lines, SUIT-2 and MIAPaCa-2 with differential gemcitabine resistance, and assessment of apoptosis demonstrated that drug associations increased the apoptotic index in both cell lines. Treatment with gemcitabine induced the expression of survivin and XIAP in both cell lines, indicating the induction of chemoresistance. In conclusion, these data demonstrate that the combination of gemcitabine with R1507 and/or metformin has an additive effect in pancreatic cancer cell lines with differential sensitivity to gemcitabine; however, gemcitabine may induce chemotherapy resistance.


Chambers J.D.,Institute for Clinical Research | Chambers J.D.,Tufts University | May K.E.,Institute for Clinical Research | Neumann P.J.,Institute for Clinical Research | Neumann P.J.,Tufts University
Health Affairs | Year: 2013

The Food and Drug Administration (FDA) and Medicare use different standards to determine, first, whether a new drug or medical device can be marketed to the public and, second, if the federal health insurance program will pay for use of the drug or device. This discrepancy creates hurdles and uncertainty for drug and device manufacturers. We analyzed discrepancies between FDA approval and Medicare national coverage determinations for sixty-nine devices and Part B drugs approved during 1999-2011. We found that Medicare covered FDA-approved drugs or devices 80 percent of the time. However, Medicare often added conditions beyond FDA approval, particularly for devices and most often restricting coverage to patients with the most severe disease. In some instances, Medicare was less restrictive than the FDA. Our findings highlight the importance for drug and device makers of anticipating Medicare's needs when conducting clinical studies to support their products. Our findings also provide important insights for the FDA's and Medicare's pilot parallel review program. © 2013 Project HOPE-The People-to-People Health Foundation, Inc.


Sakai S.,Osaka University | Moriyama K.,Kyushu University | Taguchi K.,Institute for Clinical Research | Kawakami K.,Kyushu University
Biomacromolecules | Year: 2010

Hematin, an iron-containing porphyrin used in the management of porphyria attacks, was evaluated as an alternative catalyst to horseradish peroxidase (HRP) for in situ gelation of polymers with phenolic hydroxyl (Ph) moieties in vivo. An aqueous solution of gelatin derivative with Ph moieties was gellable in the presence of both hematin and H2O2. A total of 98.6% adhesion of L929 fibroblast cells 4 h after seeding and their similar morphology to those on substrate coated with unmodified gelatin indicated no obvious substrate cytotoxicity. High cytocompatibility of the gelation process under conditions inducing gelation within 20 s was demonstrated by 95.0% viability of enclosed cells in vitro. Furthermore, no adverse effects of hematin were found compared with HRP by histological observation of cutaneous tissue surrounding in situ formed gels. The versatility of hematin for gelation of a variety of polymers possessing Ph groups was demonstrated by the gelation of a carboxymethyl cellulose derivative. © 2010 American Chemical Society.

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