In response to the high demand for key information and best practices for working with clinical oversight groups, ExL proudly presents the Clinical Oversight Groups conference to take place on October 1415, 2009 in Loews, Philadelphia, Pennsylvania. Sponsors now have the opportunity to learn from industry professionals on how to improve trial managements and decision making through successful interactions with oversight groups.

This groundbreaking event provides clinical trial sponsors with practical information about the purpose, role and responsibilities of each of these types of oversight groups. The overall objectives of the conference are to Establish parameters for the use of oversight groups, so that sponsors have a clear understanding of when each type of oversight group is needed for a clinical study.

Provide practical guidance on how to develop appropriate guidelines for oversight group implementation, so that sponsors are familiar with best practice for oversight group compilation, workflow, dataflow, data capture and data analysis.

Present effective models for use of multiple oversight groups on a single trial, so that sponsors gain insight into the relationships between their CECs, DMCs and Steering Committees. This aspect of the conference will address the areas in which oversight group communications and data exchanges most often intersect. It will also cover the areas in which appropriate boundaries and firewalls must be established between oversight groups.

Address best practices to support effective interactions between sponsors and their oversight groups, so that appropriate communications and data exchanges transpire, yet the independent nature of the oversight groups is preserved. Background

Clinical oversight groups are an important part of a sponsors management strategy for multiple aspects of a wide number of clinical studies. Implementation of expert oversight groups, whose members are independent of the trial sponsor, ensures an objective review of trial data for a number of purposes. Clinical Endpoint Committees (CECs) review and adjudicate study endpoints and provide standardized results which are utilized for statistical analyses of efficacy and safety outcomes. Data Monitoring Committees (DMCs) conduct periodic review of accumulating trial data to monitor patient safety and continually evaluate the emerging BenefitRisk balance data that is produced as a result of protocol implementation. Steering Committees collaborate with the sponsor across the continuum of trial management, from protocol development to oversight of trial conduct to interpretation of study results. Clinical oversight groups bring value by helping sponsors design and conduct trials that are ethical and that produce valid and credible results.

Having full knowledge and understanding of CEC, DMC and Steering Committee processes enables sponsors to successfully implement oversight groups in appropriate settings, resulting in sound and effective decision making for ongoing clinical projects.

Conference Sponsors

The event is sponsored by Axio and Quintiles, and supported by the Society for Clinical Data Management (SCDM) and the Association of Clinical Research Professionals (ACRP).

Additional Information

The Clinical Oversight Groups complete program is available for review here.

For registration information, visit the conference website or email register@exlpharma.com. Please reference priority code P434PR when registering or inquiring about the event.

Take advantage of the special group discounts. Register three people and receive 15% off of each registration. Register four people and receive 25% off of each registration. Please note that all three must register at the same time.

About ExL Pharma

ExL Pharma is a leader in developing innovative, educational events that serve the healthcare community and allied professionals. Behind a diverse conference portfolio, an experienced team conducts extensive market research and targeted outreach. The results translate into innovative, highquality conference events designed to exceed the dynamic informational needs of the healthcare community.

Source
Jasmaine John

Surgeons from Hospital for Special Surgery in New York have identified a drilling technique that improves the outcome of surgery to reconstruct the anterior cruciate ligament (ACL). The news is being presented during the annual meeting of the American Orthopedic Society for Sports Medicine, June 9 12, in Keystone. Colo.

“We found that the anatomy was better reproduced with the anteromedial portal drilling technique compared to the transtibial technique,” said Asheesh Bedi, M.D., a fellow in sports medicine and shoulder surgery at Hospital for Special Surgery who was involved with the study.

In recent years, an improved understanding of the anatomy of the ACL has allowed surgeons to refine techniques to reconstruct the ACL. Investigators at Hospital for Special Surgery (HSS) set out to compare the outcomes of surgeries using two common techniques. “The goal in repairing the ACL is to recreate the normal anatomy, and there are a variety of different techniques to prepare tunnels for ACL reconstruction that have evolved over time,” said Dr. Bedi. “The focus of the study was to compare two very common techniques in terms of their ability to reproduce the native ligament anatomy and restore the stability of the knee after reconstruction in a cadaveric model.”

The investigators used ten matched cadaveric knees to directly compare the transtibial and anteromedial portal drilling technique. The researchers found that the transtibial technique could not reproduce the position of the ACL, whereas the anteromedial portal drilling technique could better restore the native anatomy. The transtibial technique also presented additional concerns. “In preparing the femoral tunnel using the transtibial technique, the tibial tunnel is inadvertently rereamed as much as 30 percent and can lead to significant timezero tunnel expansion,” Dr. Bedi said. The transtibial reconstruction also performed inferiorly to the medial portal on a number of biomechanical parameters of stability assessed with computer navigation.

“This study clearly demonstrates that restoring the anatomy of the ACL and the stability of the knee is far superior when the femoral socket is reamed through the anteromedial portal rather than the tibial tunnel, as has been traditionally done by most surgeons,” said David W. Altchek, M.D., attending orthopedic surgeon and cochief of the Sports Medicine and Shoulder Service at HSS. “HSS is an international leader in this innovative solution toward further improving patient outcomes in ACL surgery.”

According to Dr. Bedi, the work has translated into modified techniques in the operating room at HSS, where more than 800 ACL surgeries are performed each year. Tears of the ACL are quite common, with between 70,000 and 80,000 reported each year in the United States.

Other researchers involved in the study are Volker Musahl, M.D., Volker Steuber, M.D., Daniel Kendoff, M.D., Answorth A. Allen, M.D., and Andrew D. Pearle, M.D., all with the Sports Medicine and Shoulder Service at HSS.

Source
Phyllis Fisher

What

Physician leaders from McAllen, Texas, and other border communities discuss the challenges of providing health care to patients at news conference. The physicians are calling upon President Obama to visit their communities to learn firsthand the struggles physicians face in delivering health care to the poorest and unhealthiest population in the nation. The region rates among the highest in the nation for residents who are living in poverty, uninsured, obese, and diabetic. The demand for health care is great. However, the region also has one of the lowest rates of physicians per capita to care for its poor and sick and to promote healthy behaviors and prevention of disease.

When

Tuesday, June 23, at 230 pm

Where

Longworth Building, 6th Floor, Room1629, Washington, D.C.

Who

Physicians leaders who care for Texas border patients.

Carlos Cardenas, MD, McAllen gastroenterologist Chair, Board for Doctors Hospital at Renaissance in McAllen, Texas; and member, Texas Medical Association (TMA) Board of Trustees

James Stewart, MD, McAllen internist President, HidalgoStarr County Medical Society, and member, TMA Council on Health Promotion and Border Health Caucus

Manny Acosta, MD, El Paso surgeon Chair, Border Health Caucus, and consultant, TMA Council on LegislationE. Linda Villarreal, MD, Edinburg internist Member, TMA Council on Legislation; delegate, Texas Delegation to the American Medical Association (AMA); district chair, TMA Political Action Committee; and member, Border Health Caucus

When 8 July 2009 600pm 800pm

What Launch of the APPGs report into inequalities of access to services for people with Parkinsons and their carers.

In response to the report, the Parkinsons Disease Society will also launch Fair Care for Parkinsons, calling for the Government to ensure the APPG report recommendations are carried out.

Where Macmillan Room, Portcullis House, Westminster

An inquiry by the All Party Parliamentary Group (APPG) for Parkinsons has highlighted severe inequalities in access to Parkinsons services, despite the clear standards and evidence base set out in the National Service Framework for long term neurological conditions, and the NICE Parkinsons disease guideline.

Nearly 400 individuals and organisations including national and local health and social care providers, regulators, professional bodies and charities, provided written and oral evidence to the inquiry.

The disturbing findings from this report will be announced on 8 July 2009.

The PDS is launching Fair Care for Parkinsons to ensure all people affected by Parkinsons have equal access to the services they need.

Guest speakers will include

Baroness Gale, Chair, APPG for Parkinsons Disease
Ann Keen MP, Parliamentary Under Secretary for Health Services
Steve Ford, Chief Executive of the Parkinsons Disease Society
A speaker sharing their experiences of living with Parkinsons

About the APPG for Parkinsons Disease

Chair of the APPG for Parkinsons Disease

Baroness Gale

Officers of the APPG for Parkinsons disease

Baroness Finlay of Llandaff ViceChair
Mark Hunter MP ViceChair
Anne Milton MP ViceChair
Jeremy Browne MP Treasurer
Lord Brooke of Sutton Mandeville Secretary
Paul Burstow MP Secretary
Madeleine Moon MP Secretary
The APPG for Parkinsons Disease was established in June 2008 in order to keep Parkinsons disease and relevant public policy issues on the political agenda
The Parkinsons Disease Society (PDS) acts as Secretariat for the APPG for Parkinsons disease
The PDS members survey 2007 Life with Parkinsons today room for improvement identified that access to public services such as the NHS, social services and transport in England for people with Parkinsons and their carers varies considerably

About Parkinsons Disease

Approximately 120,000 people in the UK have Parkinsons
10,000 people are diagnosed in the UK every year, and one in 20 is under 40
Parkinsons is a progressive neurological condition caused by the loss of dopamine in the brain, for which there is currently no cure. Whilst it is not life threatening, Parkinsons seriously affects day to day activities that we take for granted like walking, writing, speaking

Key symptoms are

Tremor

1 Rigid muscles
2 Slowness of movement

Kansas State University once again is host to a noted microbiology workshop that helps the scientists who test food and other samples for microorganisms. KStates 29th annual Rapid Methods and Automation in Microbiology workshop will be June 1926.

The workshop, now in its 29th year, has served more than 4,000 participants from across the United States and 60 countries.

Rapid methods and automation are a dynamic area in applied microbiology dealing with the study of improved methods in the isolation, early detection, characterization and enumeration of microorganisms and their products in clinical, food, industrial and environmental samples. The KState workshop will focus on the practical application of conventional and new commercial systems of rapid identification of microorganisms from medical specimens, foods, water and the environment.

Workshop participants will receive intensive theoretical and handson training in microbiological automation. Lectures and classes will be at the Clarion Hotel in Manhattan and at Call Hall and the College of Veterinary Medicine complex on the KState campus.

The awardwinning workshop is under the direction of KStates Daniel Y.C. Fung, an internationally known authority in the field and professor of animal sciences and industry and food science. It also is offered as a class worth two graduate credits through the KState department of animal sciences and industry and KStates Food Science Institute.

Source
Daniel Y.C. Fung

Health outcomes explored at DDW 2009

Researchers are making great strides in understanding the development and treatment of inflammatory bowel disease, a chronic inflammatory condition of the digestive tract that affects more than a half million Americans, according to several studies being presented at Digestive Disease Week® 2009 (DDW®). DDW is the largest international gathering of physicians and researchers in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery.

Inflammatory bowel disease (IBD) is a term that refers to both ulcerative colitis and Crohns disease. Ulcerative colitis is a disease of the colon in which inflammation of the lining of the large intestine occurs. Crohns disease causes inflammation of the lining and wall of the large and/or small intestine. When inflamed, the lining of the intestinal wall is red and swollen, becomes ulcerated, and bleeds.

“There is still a lot we dont know about the natural history and course of inflammatory bowel disease,” said Sunanda V. Kane, MD, AGAF, Mayo Clinic, Rochester. “Work in the epidemiology of these conditions suggests an increase in incidence, making the study of its genesis and treatment that much more important.”

Patients with IBD Are Exposed to Potentially Serious Excesses of Ionizing Radiation (Abstract #650)

Patients with inflammatory bowel disease (IBD), Crohns disease (CD) and ulcerative colitis (UC) have frequent radiologic examinations and may be at risk for excessive radiation exposure. These gastrointestinal conditions often affect young people, who are then frequently examined with a CT scan to assess for complications or the activity of their disease. Investigators sought to discover how many radiological procedures patients underwent and to how much ionizing radiation they were exposed.

Frequency and age are key factors in the question of whether too much radiation exposure is problematic in part because CD is a chronic, incurable disease. The patient who is diagnosed at a young age may receive multiple imaging tests, and the younger a patient is when first exposed to radiation, the more at risk they are of having damage to their DNA.

Investigators identified approximately 500 patients with CD and UC to study the number and type of radiologic tests taken over a fiveyear period to learn how many scans or Xrays patients had been exposed to in an effort to measure radiation exposure rates. They found that patients with CD were exposed to twice as much radiation as patients with UC. Lead researcher Karen Kroeker, MD, fellow with the division of gastroenterology at the University of Alberta, said this may be because CD often leads to complications, such as intestinal obstruction and/or fistula that require radiologic tests for their diagnosis.

Dr. Kroeker found that the majority of radiation about 66 percent to 75 percent was generated from CT scans, a finding she says is attributable to the fact that CT scans have become readily available in most hospitals over the last 20 years and are excellent tools for diagnosing the complications associated with IBD. Almost every hospital has a CT scanner, which is beneficial because they provide very good information, said Dr. Kroeker, fellow, division of gastroenterology at the University of Alberta. But CT scans invariably produce more radiation than a simple Xray or MRI. However, Kroeker adds that Xrays and MRIs are generally less valuable than CT scans in diagnosing the complications associate with IBD.

“We know that CT scans are excellent diagnostic tests, however they do have the potential risk of exposure to ionizing radiation. Physicians need to test, explore and learn about new and better diagnostic modalities, such as intestinal ultrasound, that could eventually replace CT scan,” said Dr. Kroeker. “In addition, physicians need to be aware of how many CT scans their patients have been exposed to so that they can determine the risk of additional CT scans.”

Dr. Kroeker will present these data on Tuesday, June 2 at 1030 a.m. CDT in S406A, McCormick Place.

A Randomized Controlled Trial of Growth Hormone in Active Pediatric Crohns Disease (Abstract #74)

Administering growth hormone to pediatric Crohns disease (CD) patients may not only reverse growth failure, but may also be effective in reducing symptoms and improving disease activity.

Researchers at Cincinnati Childrens Hospital Medical Center sought to determine whether previous success in improving symptoms with growth hormone in adult CD patients could be replicated for pediatric CD patients along with an improvement in growth failure. As many as 80 percent of children with CD experience growth failure, low muscle build up and weakened bones as a result of the disease. The best window for “catchup growth” is before age 12.

Twenty children, ranging in age from seven to 18, were enrolled in the study, with 10 receiving the growth hormone and 10 in the control group. Investigators found that after three months, the disease in twothirds of the patients receiving the growth hormone went into remission. After one year, study participants continuing to receive the growth hormone also achieved a significant improvement in growth. For most, this resulted in “catchup” towards the height they would have been predicted to reach prior to becoming ill.

“Our results are very encouraging,” said Lee Denson, MD, director of the SchubertMartin Inflammatory Bowel Disease Center at Cincinnati Childrens and associate professor of pediatrics at the University of Cincinnati College of Medicine. “With minimal side effects, including the burden of receiving daily injections and mild joint pain, growth hormone holds tremendous potential for improving both symptoms and growth in pediatric CD patients.”

Dr. Denson, who conducted the study along with David Klein, MD, PhD, of the division of endocrinology at Cincinnati Childrens, said that while the results of this study are encouraging, a larger, multicenter study would need to be conducted in order to determine which children with CD might receive the most benefit from growth hormone.

Dr. Denson presented these data on May 31.

Increased Risk of Inflammatory Bowel Disease After Salmonella or Campylobacter Gastroenteritis A PopulationBased Study (Abstract #80)

Researchers in Denmark have discovered a link between inflammatory bowel disease (IBD) and an initial bacterial infection with either salmonella or campylobacter gastroenteritis, an important step in understanding the development of IBD that may help explain the increasing incidence of IBD over the past decade.

Denmarks system of tracking its citizens with individual identification numbers allowed researchers to examine patient interaction with the healthcare system over a 15 year period. Investigators examined how many patients in a control group would develop IBD and compared them with those who have been exposed to bacteria in the past. They found that over 15 years, three times as many patients who had been exposed to bacteria later developed IBD as those who had not been exposed.

“This is the first time we are able to make such a clear association with an initial exposure to bacteria and subsequent development of IBD in the long term,” said Nielsen Henrik, MD, professor of infectious diseases at Aalborg Hospital in Denmark. “Our research has important implications for food safety and disease prevention. If we can reduce and prevent the spread of food bacteria and infections, we may reduce or even largely eliminate IBD in the long term.”

Dr. Nielsen is hopeful that further research will go beyond the association between bacteria exposure and IBD established in his study and attempt to prove causality by studying in detail the biology of individual patients.

Dr. Nielsen presented these data on May 31.

Associated of MethicillinResistant Staph Aureus (MRSA) with Higher Mortality Among Hospitalized IBD Patients (Abstract #S1103)

A new study suggests that patients with inflammatory bowel disease (IBD) who require frequent hospitalization and medications that weaken their immune systems may be more susceptible to MRSA (Methicillinresistant Staph aureus) infection and other hospitalacquired infections.

“Our study showed that IBD patients with MRSA are four times as likely to die in the hospital,” said lead investigator Geoffrey Nguyen, MD, PhD, assistant professor of medicine, Mount Sinai Hospital (University of Toronto) and Johns Hopkins School of Medicine. “But patients with other GI conditions who are infected with MRSA were half as likely to die.”

Researchers looked at cases of IBD patients between 1998 and 2004 and found that hospitalized patients with IBD were 42 percent more likely to acquire MRSA than patients with other gastrointestinal illnesses. Patients with Crohns disease were especially susceptible, possibly because their medication can weaken the immune system.

Dr. Nguyen cautioned that the study does not necessarily mean that MRSA is the cause of increased mortality among IBD patients, only that the possible relationship should be studied further. Also, the data looked at in this study were retrospective; investigators did not have information on the exact date and time of death, nor the exact cause of death. In subsequent research they plan to follow IBD patients who contract MRSA and track whether their cases are fatal. “Based on what this data seems to show, we think IBD patients are more susceptible to MRSA but we need further prospective studies to confirm this,” said Dr. Nguyen.

The study also looked at other factors that could allow for the discrepancy and found that IBD patients with C.difficile infection were at double the risk of contracting MRSA. They also found differences in rate of infection depending on age the older the patients were, the more susceptible they may have been. There also seemed to be increased risk associated with patients receiving Medicare or Medicaid, a factor which Dr. Nguyen said should be looked at more closely.

Dr. Nguyen presented these data on May 31.

The Changing Pattern of Crohns Disease Incidence According to Age in Northern France A Constant Increase in the 019 Years Age Group (Abstract #114)

A populationbased study of residents in northern France finds that the incidence of Crohns disease (CD) is on the rise, most dramatically among young people less than 19 years of age. The findings raise a number of questions about the likely causes of the increase, which the investigators say could be related to environmental factors.

Investigators from the EPIMAD registry in France tracked rates of CD among nearly six million patients in northern France between 1988 and 2005. They found that the incidence of CD among all patients increased 20.7 percent but that rates had stabilized 10 years into the study. Among young people less than 19 years of age however, the incidence of CD increased linearly by 48.5 percent.

The cause of the increased incidence of CD among young people is unknown, but investigators say aggravating factors like environmental pollution and changes in diet or smoking habits could be culprits.

“Since we now know that CD disproportionately affects young people, future studies to uncover its cause should focus on this age group,” said Guillaume Savoye, MD, EPIMAD registry and department of gastroenterology, University Hospital, Rouen, France.

Dr. Savoye presented these data on May 31.

Source
Aimee Frank

Results and additional analyses from the Phase II portion of a Phase II/III clinical trial of Cortheras investigational drug relaxin for the treatment of acute heart failure will be presented at the Heart Failure Congress, the annual meeting of the Heart Failure Association of the European Society of Cardiology in Nice, France.

Marco Metra, M.D., professor of cardiology at the University of Brescia, Italy, and coprincipal investigator of the PreRELAXAHF study, will present the main results from the multicenter, international PreRELAXAHF study at 830 a.m. CET on Sunday, May 31, at the Judges Choice oral abstracts session. Dr. Metra will also present additional analyses of the PreRELAXAHF study during a latebreaking clinical trials session at 1115 a.m. CET on Monday, June 1. Five posters from the PreRELAXAHF study will also be presented from 830 a.m. to 1230 p.m. CET on Monday, June 1.

About Relaxin

Relaxin is a naturally occurring peptide hormone that acts as a systemic and renal vasodilator. Elevated levels of relaxin modulate increases in renal and cardiac function that meet the increased hemodynamic demands of pregnancy. Consistent with this natural role of the hormone, pharmaceutically manufactured relaxin has been shown to have these effects in multiple human studies of men and nonpregnant women, including patients with heart failure.

About Corthera

Corthera Inc. is a private biopharmaceutical company committed to acquiring, developing and commercializing therapies for illnesses in the acute care setting. Cortheras lead product candidate, relaxin, is currently being evaluated in clinical trials for acute heart failure. The company has worldwide rights to develop and commercialize relaxin.

Pathfinders, a program designed to care for the whole person body, mind and spirit has been found to help women with terminal cancer cope and has improved their quality of life, according to a study led by researchers in the Duke Comprehensive Cancer Center.

“The program helped improve distress and despair during the initial three months and up to six months after diagnosis among women with metastatic breast cancer and a six month life expectancy,” said Amy Abernethy, M.D., an oncologist at Duke University Medical Center and lead investigator on the study. “Even though the women were getting sicker and experiencing more symptoms related to their cancer, they reported that they felt less distress and despair as a result of being able to better cope with the cancer.”

Pathfinders focuses on the seven pillars of personal recovery hope, balance, inner strengths, self care, support, spirit and life review. The program provides patient navigation, counseling, coping skills training, mind and body techniques and lifestyle advice.

“The goal of the program is to teach patients coping skills for dealing with their cancer,” said Tina Staley, director of Pathfinders. “To reach this goal, we have created a common language between patients, nurses, physicians and Pathfinders for communicating coping skills.”

For this pilot study, the researchers enrolled 50 adult breast cancer patients with a prognosis of less than six months survival. The women met with a Pathfinder, a trained social worker, at least monthly, plus telephone conversations and email exchanges. The social workers helped the women identify inner strength, taught them coping skills and encouraged them to engage in complementary and alternative medical services.

The researchers present their findings on a poster at the 2009 American Society of Clinical Oncology meeting in Orlando, on Sunday, May 31.

“There is a growing body of data that shows cancer patients have unmet psychosocial needs, and with programs like Pathfinders we are able to care for the whole person,” Abernethy said. “As a result, we found that this group of women reported a higher quality of life three months after being diagnosed than was expected.”

Additional authors on the study include Tina Staley, James Herndon II, April Coan, Jane Wheeler, Krista Rowe, Barbara Horne and H. Kim Lyerly of Duke.

Source
Erin Pratt