News Article | December 1, 2016
DrugDev believes the only way to achieve real change in clinical research is through industry-wide collaboration, standardization and a beautiful technology experience. All three tenets were on display at the 2nd Annual DrugDev User Summit (hosted by Merck) which convened more than 100 clinical trial leaders from over 40 sponsor, CRO and site organizations to discuss innovation and the future of clinical research. “The DrugDev User Summit was a very engaging event,” said Dawn Furey, Executive Director/Head, Global Operations, at Merck. “To be honest, I didn’t think I would stay for the entire two days given my competing priorities, but I couldn’t step away. It was great.” Plenary and workshop sessions featured expert speakers from Merck, Janssen (last year’s host), Pfizer, Novartis, Eli Lilly, ICON, Boehringer-Ingelheim, InCyte, INC Research, Alkermes, BioMarin, Chesapeake IRB, Radiant Research, and Emerson Clinical Research Institute. Highlights from the agenda included: In addition to these engaging discussions, a key benefit of Summit was the sneak preview of upcoming DrugDev technology that will unify solutions to revolutionize how sponsors and CROs run clinical trials at a truly enterprise level. Featuring a single interface that spans functional areas and incorporates the DrugDev Golden Number, DrugDev customers will be the first to access dashboard reports, manage task lists, and track progress across hundreds of trials from one centralized and convenient resource. Attendees were buzzing about the exclusive solution, which will be officially unveiled in early 2017. Brenda Medina, Associate Director, Head of Analytics at BioMarin said, “I already use multiple DrugDev solutions so I find real value in a unified clinical suite that ties everything together. I’m excited to see how this tool will enable the industry to really bring drugs to market faster for our patients, as time is of the essence for us in the industry, and our patients are waiting." Attendees also participated in hands-on technology demos, provided valuable feedback to help guide future solutions, and enjoyed social networking events to build even stronger relationships with peers. “People who know me will be shocked at how little I have to say about the DrugDev User Summit,” said Ibraheem “Ibs” Mahmood, DrugDev President and CEO. “That’s because the beauty of the event wasn’t the agenda, which was wonderful, but rather bringing together all of these thought leaders into one room with one focused mission. That allowed me to take a step back and watch everyone share best practices, debate solutions to common challenges, and brainstorm ideas with each other. For over 100 clinical professionals to dedicate so much time to a vendor user meeting – which is bigger than some industry conferences – and then to be so engaged throughout it was a truly humbling experience. I consider it a strong testament to the impact DrugDev provides our customers, and I’ve never been more optimistic about the possibility of real change or more excited about the future of clinical research.” The DrugDev User Summit is complimentary for the sponsors, CROs and sites that use DrugDev technology on thousands of clinical trials worldwide. Host and dates for the 2017 Summit have not yet been announced. To learn more about DrugDev’s unified clinical operations suite, visit drugdev.com. DrugDev’s unified clinical suite enables sponsors, CROs and sites to do more trials through industry-wide collaboration, standardization and a beautiful technology experience. Featuring solutions for global site payments, site identification and activation, workflow optimization, learning management, and site and patient engagement, DrugDev helps companies transform the quality and efficiency of clinical trials from startup through closeout. The company also powers the revolutionary TransCelerate Investigator Registry and Investigator Databank collaborations with the universal identifier known as the DrugDev Golden Number. Learn more at http://www.drugdev.com.
News Article | December 14, 2016
DALLAS, Dec. 14, 2016 -- People who were in a stable marriage, and had never been divorced or widowed, had the best prospects of survival after having a stroke, according to new research in Journal of the American Heart Association, the Open Access Journal of the American Heart Association/American Stroke Association. "Our research is the first to show that current and past marital experiences can have significant consequences for one's prognosis after a stroke," said Matthew E. Dupre, Ph.D., lead author and associate professor in the Department of Community and Family Medicine and the Clinical Research Institute at Duke University in Durham, North Carolina. "We hope that a greater recognition and understanding of these associations may enable healthcare providers to better identify and treat patients who may be at a potentially high risk of dying after suffering a stroke." Stroke, one of the leading causes of disability and death in the United States, affects nearly 800,000 adults each year. The risk factors associated with stroke -- high blood pressure, smoking and diabetes -- are well established, as are the factors related to recovering from stroke and improving survival, such as access to quality healthcare, reducing risk factors, and adhering to treatment plans. While studies have shown that social support, such as marriage, can have a significant impact on treatment of cardiovascular disease, the influence of marital status on stroke survival in adults remains poorly understood. To determine whether one's marital history plays a role in survival after suffering a stroke, Dupre and Renato D. Lopes, M.D., Ph.D., professor of medicine at Duke University Medical Center, used data from a nationally representative sample of older U.S. adults. The sample was collected as part of the Health and Retirement Study (HRS), an ongoing, prospective, study of older U.S. adults sponsored by the National Institute on Aging and the Institute for Social Research at the University of Michigan. The HRS includes marital histories from more than 50 years of prospective and retrospective interview data. For this study, the researchers selected respondents who reported a stroke from 1992 to 2010. The final sample included 2,351 adults aged 41 and older who were observed an average of 5.3 years over the 18-year study period. The researchers found: The risks of dying after a stroke were 71 percent greater for adults who never married than for adults who were continuously married. For patients who were divorced or widowed, the risks of dying after a stroke were 23 percent and 25 percent greater, respectively, than continuously married adults. In patients who were divorced or widowed more than once, the risks of dying after a stroke were 39 percent and 40 percent greater, respectively, than for continuously married adults. There was no evidence that the findings significantly differed between men and women or by race or ethnicity. Analysis of the data suggests that some of these risks are affected by differences in psychological and social factors, such as lack of children, limited social support and depressive symptoms that may have impeded recovery after a stroke. Multiple marital losses in one's lifetime were especially detrimental to recovery, regardless of one's current marital status. Unexpectedly, the researchers found that remarriage did not reduce the risks from past divorce or widowhood. A limitation of the study is that it only included adults who survived to hospital discharge and did not include those who died shortly after having a stroke. The results of this study have possible implications for public health awareness and practice, Dupre said. "More research is needed to know the full clinical implications of our findings. Greater knowledge about the risks associated with marital life and marital loss may be useful for personalizing care and improving outcomes for those who are recovering from a stroke." Author disclosures are on the manuscript. The National Institute on Aging funded the study. Stroke images are located in the right column of this release link http://newsroom. After Dec. 14, 2016, view the manuscript online. About Stroke Follow AHA/ASA news on Twitter @HeartNews. For updates and new science from JAHA, follow @JAHA_AHA. Statements and conclusions of study authors published in American Heart Association scientific journals are solely those of the study authors and do not necessarily reflect the association's policy or position. The association makes no representation or guarantee as to their accuracy or reliability. The association receives funding primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific association programs and events. The association has strict policies to prevent these relationships from influencing the science content. Revenues from pharmaceutical and device corporations are available at http://www. .
News Article | October 28, 2016
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.
News Article | November 14, 2016
Today, at American Heart Association’s Scientific Sessions 2016, digital health coaching startup Vida Health released findings from a peer-reviewed study of patients self-managing risk prevention after acute myocardial infarction (MI). The study, conducted with Duke Clinical Research Institute and AstraZeneca, found a statistically significant increase in pre- and post-intervention Patient Activation Measure (PAM) scores in ten cardiac patients using Vida’s coaching app on their smartphones. Prior research has shown that an increase in PAM scores of this magnitude is associated with increased medication adherence and reduced hospital utilization. “We are excited by these results, as they are consistent with what we see every day with cardiac patients who use Vida’s coaching app,” said Vida CEO and Co-founder Stephanie Tilenius. “To date, there has been little research on the acceptance and efficacy of using smartphones to deliver coaching and personalized support to post-acute myocardial infarction patients; this study demonstrates that patients can achieve improved outcomes with Vida’s coaching and content tailored specifically to their needs and delivered seamlessly through their mobile device.” A total of 21 participants (10 patients and 11 caregivers) completed the four-week intervention. The mean age of patients was 57 years, and 20% were women; caregivers had a mean age of 54 years and the majority (88%) were women. On average, participants engaged in one live video/phone consultation per week and opened the Vida app five times per week. Patients and caregivers texted an average of twenty-four and eight times per week, respectively. After the four-week coaching intervention in the post-MI cohort, patients were significantly more likely to agree with the statements “I have been able to maintain (keep up with) lifestyle changes, like eating right or exercising,” and “I know what treatments are available for my heart attack.” Eight out of ten patients (80%) said they would go to cardiac rehab after coaching, compared to the traditional 25% of post-MI patients who participate in cardiac rehab. Participants reported high levels of satisfaction with the program, with an average satisfaction rating of 8.3/10 across the patient and caregiver cohorts, and an average net promoter score of 61%, which is comparable to customer satisfaction levels for Apple’s iPhone. “Post-MI patients and caregivers embraced digital health coaching with high rates of interactivity, and patients reported increased PAM scores, which measure engagement in self-management and medication compliance,” said Dr. Tracy Wang of the Duke Clinical Research Institute. “We believe these early results demonstrate the significant value of mobile phone-based health coaching programs in augmenting rehabilitation in post-MI patients to reduce readmissions for cardiac patients.” In the U.S., about 735,000 people have a heart attack every year. Of these, 210,000 are second heart attacks. The average cost to traditional health insurers for the first 90 days following a heart attack is $38,501. The risk of a second heart event is reduced through lifestyle changes that include increased physical activity, stress management, improved diet, and medication adherence. About Vida Vida Health is a mobile-first personal health platform that helps people prevent, manage and reverse chronic conditions including diabetes, hypertension, mental health issues, and more. Utilizing data from connections to over 100 apps and devices, Vida creates a personalized care approach for each individual that can include 1:1 coaching from a professional health coach and customized content from evidence-based clinical programs. The company's revenues are predominantly derived from enterprise level contracts with Fortune 500 companies, major national payers and large providers. Partners include Steelcase, eBay, FICO, UnitedHealthcare, Mercy, Duke, Stanford, and many others. About Duke Clinical Research Institute The Duke Clinical Research Institute (DCRI) is the world's largest academic clinical research organization. Its research spans multiple disciplines, from pediatrics to geriatrics, primary care to subspecialty medicine, and genomics to proteomics. About AstraZeneca AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas - Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit http://www.astrazeneca.com and follow us on Twitter @AstraZeneca.
Kerwin E.M.,Clinical Research Institute |
D'Urzo A.D.,University of Toronto |
Gelb A.F.,Southern California Clinical Trials |
Lakkis H.,Forest Research Institute Inc. |
And 2 more authors.
COPD: Journal of Chronic Obstructive Pulmonary Disease | Year: 2012
Background: This Phase III study evaluated the efficacy and safety of twice-daily aclidinium 200 μg and 400 μg versus placebo in the treatment of moderate-to-severe COPD. Methods: In this 12-week, double-blind, multicenter trial, patients were randomized (1:1:1) to inhaled twice-daily aclidinium 200 μg, aclidinium 400 μg, or placebo. Primary and secondary endpoints were changes from baseline in trough FEV1 and peak FEV1 at Week 12, respectively. Health status (St. George's Respiratory Questionnaire [SGRQ]), COPD symptoms (Transitional Dyspnea Index [TDI], night and early morning symptoms), and safety were also assessed. Results: A total of 561 patients (mean age, 64 ± 9 years) with a mean baseline FEV1 of 1.36 ± 0.54 L (47.2% of predicted value) were randomized. At Week 12, aclidinium 200 μg and 400 μg showed significant improvements from baseline in mean (95% CI) trough FEV1 compared with placebo by 86 (45, 127) mL and 124 (83,164) mL, respectively, and in peak FEV1 by 146 (101, 190) mL and 192 (148, 236) mL, respectively (p ≤ 0.0001 for all). Both aclidinium doses also provided significant improvements in SGRQ, TDI and almost all COPD symptom scores compared with placebo (p < 0.05 for all). Incidences of adverse events (AEs) were similar across treatment groups. The incidence of anticholinergic AEs was low and similar across groups (dry mouth: 0.5%1.6%; constipation: 0%-1.1%). Conclusions: Treatment of moderate-to-severe COPD patients with twice-daily aclidinium 200 μg and 400 μg was associated with significant improvements in bronchodilation, health status, and COPD symptoms. Both doses were well tolerated and had safety profiles similar to placebo. © 2012 Informa Healthcare USA, Inc.
Park Y.H.,Seoul National University |
Seo S.Y.,Clinical Research Institute |
Lee E.,Clinical Research Institute |
Ku J.H.,Seoul National University |
And 2 more authors.
Journal of Urology | Year: 2013
Purpose: In castrate resistant prostate cancer cells we investigated the cytotoxic effect of simvastatin and the mechanism involved. Materials and Methods: After treating PC3 and DU-145 cells with simvastatin, cell viability and apoptosis were determined using tetrazolium salt based colorimetric assay and annexin-V-fluorescein isothiocyanate/propidium iodide double staining assay, respectively. To determine whether simvastatin affects the nuclear factor-κB pathway, we assessed IκBα and phosphorylated IκBα expression, and p65 and phosphorylated p65 subcellular localization by Western blot analysis. Also, changes in nuclear factor-κB transcriptional activity were assessed using a luciferase reporter assay. Results: After treating PC3 and DU-145 cells with 0, 20 or 40 μM simvastatin for 24, 48 or 72 hours, the proportion of viable cells decreased and the proportion of apoptotic cells increased in a dose and time dependent manner. Western blot analysis showed that simvastatin inhibited IκBα phosphorylation and degradation. It also demonstrated that simvastatin increased p65 protein levels in cytoplasmic fractions and decreased phosphorylated p65 protein levels in nuclear fractions but did not change p65 protein levels in cytoplasm. Luciferase reporter assay showed that simvastatin dose dependently reduced nuclear factor-κB activity. Reverse transcriptase-polymerase chain reaction and Western blot revealed that simvastatin inhibited nuclear factor-κB regulated cIAP-1 and 2, cFLIP-S and XIAP expression in dose and time dependent fashion. Conclusions: Simvastatin inhibited castrate resistant prostate cancer cell growth by inducing apoptosis. These effects were probably mediated by the inhibition of IκBα phosphorylation and nuclear translocation of p50/p65 dimer in the nuclear factor-κB pathway. © 2013 American Urological Association Education and Research, Inc.
Yang X.,Shenyang Medical College |
Takano Y.,Clinical Research Institute |
Zheng H.-C.,Shenyang Medical College
Oncology Letters | Year: 2012
Gastrointestinal adenocarcinoma (GIA) is a common malignant disease worldwide. Its tumorigenesis and progression is a multistage process with the involvement of a multifactorial etiology. Knowledge regarding altered expression of these genes during carcinogenesis may not only provide information about the molecular events during the initiation and progression of cancer, but may also result in the discovery of biological markers for the evaluation of cancer diagnosis and prognosis. In this review, we assessed molecular markers of pathogenesis, invasion, metastasis and prognosis, such as tumor suppressor and metastasis suppressor genes, and angiogenesis, cell adhesion, cell mobility, ER stress, mucin production, threonine protein kinase and REG family protein expression, by the establishment of tissue microarray (TMA) of GIA and immunohistochemistry (IHC) by intermittent microwave irradiation and in situ hybridization (ISH). Finally, we characterized the pathobiological features of Lauren's and WHO subtypes. It was found that the aberrant and cell-specific expression of these molecules is important in the malignant transformation of gastrointestinal epithelium and subsequent progression. These molecules also underlie the histogenic mechanisms of gastric carcinoma according to Lauren's and WHO classification. The combination of TMA, IHC and ISH may be widely applied to screen for molecular markers in GIA.
Preskorn S.H.,University of Kansas |
Preskorn S.H.,Clinical Research Institute
Journal of Psychiatric Practice | Year: 2011
This column, the third in a series on central nervous system (CNS) drug development, discusses advances during the first decade of the 21st century and directions the field may take in the next 10 years. By identifying many possible new drug targets, the human genome project has created the potential to develop novel central nervous system (CNS) drugs with new mechanisms of action. At the same time, this proliferation of possible new targets has complicated the drug development process, since research has not yet provided guidance as to which targets may be most fruitful. This and other factors (eg, increasing regulatory requirements) have increased the cost and complexity of the drug development process. In addition, as more is learned about the biology of psychiatric illnesses, syndromes may be subdivided into more specific entities that are better understood from a pathophysiological and pathoetiological perspective. This is likely to lead to development of more targeted treatments focused on underlying causes of illness as well as prevention. The development of drugs for Alzheimer's disease is discussed as a possible model for future CNS drug development. We are at the beginning of an era when it is likely that the way in which CNS drugs are developed will need to be rethought, which will call for flexibility and creativity on the part of both drug developers and clinical researchers. Copyright © 2011 Lippincott Williams & Wilkins Inc.
News Article | January 13, 2016
President Barack Obama's choice for commissioner of the Food and Drug Administration won easy approval from a Senate panel Tuesday, but two senators - a Republican and Democratic presidential candidate Bernie Sanders - threatened to block the nominee. Sen. Lisa Murkowski said she will hold up a vote on the Senate floor until she has reassurances from the agency that it will write rules for labeling genetically modified salmon. The Alaska Republican has said the engineered salmon approved by the FDA last year could be harmful to her state's wild salmon industry. Califf is now the No. 2 official at the agency, which regulates consumer products from medications to seafood to e-cigarettes. He was a prominent cardiologist and medical researcher at Duke University for more than 30 years. Murkowski said she is angry that she didn't get more of a warning about the agency's approval of the modified fish, which she has long opposed. The FDA approved the salmon two days after Califf's November confirmation hearing. "If they are trying to get my support, they sure fumbled that ball," she said after the Senate panel approved the nomination on a voice vote. Sanders, I-Vt., also opposes Califf's nomination. The presidential contender did not attend the committee meeting, but his office said he would have voted no. Sanders has said the country needs an FDA commissioner who will stand up to the pharmaceutical industry and that Califf is "not that person." He said he is also considering a hold on the nomination. Some Democrats have raised concerns about Califf's ties to industry. In 2006, Califf founded the Duke University Clinical Research Institute, a contract research group that has conducted studies for virtually all of the world's largest drugmakers. Government disclosure forms show that Califf received more than $29,000 in consulting fees, travel, meals and other payments from drugmakers in 2014. Califf has already recused himself from dealing with certain companies to avoid conflicts of interest. "I think if you look at my record you'll find I've never been a proponent of lowering standards," Califf said during his nomination hearing. He said he declined to do many studies because drug companies wouldn't meet his criteria for data access. Califf's nomination does have the support of the Republican chairman of the Health, Education, Labor and Pensions Committee. Tennessee Sen. Lamar Alexander said Califf has been thoroughly vetted, and he is confident that Califf can lead the agency "fairly and impartially." As head of the FDA, Califf would inherit a raft of projects and potential challenges, including unfinished tobacco regulations and food safety and labeling reforms. Former FDA Commissioner Margaret Hamburg left the job early last year. The FDA's chief scientist, Dr. Stephen Ostroff, is serving as acting head of the agency.
Ohta Y.,Clinical Research Institute |
Tsuchihashi T.,Clinical Research Institute |
Kiyohara K.,Clinical Research Institute
Internal Medicine | Year: 2011
Objective Lifestyle modification as well as combination antihypertensive therapy is necessary to achieve strict blood pressure (BP) control as advocated by the guidelines for the treatment of hypertension. The aim of this study was to investigate the status of adherence to lifestyle modifications and BP control status in hypertensive outpatients. Methods and Patients Subjects are 661 hypertensive outpatients who had been followed at National Kyushu Medical Center. We assessed BP control status based on the average clinic BP on two occasions. In addition, we investigated the adherence to the individual items of lifestyle modification by a questionnaire. Results Average BP was 129 ± 10/71 ± 11 mmHg and overall rate of achieving goal BP was 60.1%. Achieving rate of each target BP category was 83.3% in the elderly patients (<140/90 mmHg), 56.7% in the young/middle patients (<130/85 mmHg) and 45.5% in the patients with diabetes mellitus/chronic kidney disease/ myocardial infarction (<130/80 mmHg). Adherance to each item of lifestyle modification was as follows: Patients who answered to be conscious about salt restriction was 80.9%, those with increased intake of fruits/vegetables was 79.0%, reduced intake of cholesterol/saturated fatty acids was 67.9%, presence of obesity was 37.7%, daily exercise for ≥30 min was 31.9%, habitual alcohol intake was 38.0%, habitual smoking was 9.8%. Only 22.5% of the patients had no lifestyle items to be modified. On the other hand, 19.6% of patients had more than 3 items to be modified. Subjects with more than 3 lifestyle items to be modified are more frequently found in young, male, and obese groups. Conclusion We conclude that about 60% of the patients achieved goal BP by the intensive combination therapy. The lifestyle modification seems to be important especially for the young, male and obese patients. © 2011 The Japanese Society of Internal Medicine.