Target Health Presenting at DIA 2012 – Visit Us at Booth #2542

 

Target Health will be presenting at the DIA Annual Meeting in Philadelphia on 26 June 2012 at 1:30 PM in room 109ab. The Forum is entitled: “Effective and Efficient Monitoring as a Component of Quality Assurance in the Conduct of Clinical Trials.

 

The forum will present data collected from the Clinical Trials Transformation Initiative (CTTI) survey on clinical trial monitoring and auditing practices used by organizations to address regulatory requirements, provide a rationale for the re-evaluation of these practices, and summarize new industry trends in the areas of monitoring and auditing of clinical trials.

 

Learning objectives: Describe, discuss, and evaluate the current state of monitoring and auditing in clinical research trials; Identify the current methods for determining the critical aspects of clinical trials; Discuss possible new approaches to clinical trial oversight.

 

CHAIRPERSON: Joan Harley, BSN, RN

 

Presentations:

 

1. Training, Site Selection, and Human Subject Protection: Factors to Consider When Developing a Monitoring Plan: Cynthia Kleppinger

 

2. Source Data Verification: Targeting Critical Elements: Cynthia Zacharias

 

3. Range of Practices for the Monitoring of Clinical Trials: Jennifer Giangrande

 

Panel: Jules Mitchel: Risk-Based and Centralized Monitoring, The Future is the Present

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website at www.targethealth.com

The Tell Tale Heart

 

Q1: If you have a heart attack, you also have heart disease.
True or False

 

Explanation: If you have a heart attack, you have heart disease. Heart disease includes a number of conditions affecting the structures or function of the heart. Common forms of heart disease are coronary artery disease, arrhythmias, heart failure, and congenital heart disease, among many others that may lead to development of a heart attack. The correct answer is: True

 

 

 

Q2: What is meant by the term myocardial infarction?

 

A. Heart failure; B. Heart attack; C. Brain aneurism; D. All of the above

Explanation: Myocardial infarction is the medical term for heart attack. The correct answer is: B Heart attack

 

 

Q3: Sudden cardiac arrest means that the heart

 

A. Stops beating; B. Beats dangerously slowly; C. Has a cycle of beating and stopping; D. Skips beats

 

 

Explanation: Cardiac arrest is the sudden loss of cardiac function, when the heart abruptly stops beating. Unless resuscitative efforts are begun immediately, cardiac arrest leads to death within a few minutes. This is often referred to by doctors as “sudden death” or “sudden cardiac death” (SCD). The correct answer is: A. Stops beating

 

 

Q4: Symptoms of heart disease can include

 

A. Dizziness, weakness, arm pain, pressure in the chest; B. Heart palpitations, shortness of breath, weakness; C. No symptoms at all; D. All of the above

 

Explanation: Because there are many forms of heart disease, there are many symptoms, including dizziness; weakness; pain that radiates to the arm, jaw, or throat; nausea; vomiting; shortness of breath; heart palpitations; chest pain, discomfort and heaviness. There are some forms of heart disease that produce no symptoms at all. The correct answer is: D. All of the above

 

 

Q5: Heart disease is the leading cause of death of American women over the age of 25

 

True or False

 

Explanation: According to the American Heart Association, cardiovascular disease is the leading killer of women over the age of 25. It kills nearly twice as many women in the United States than all types of cancer, including breast cancer. The correct answer is: True

 

 

Q6: Risks for heart disease include

 

A. High blood pressure and high cholesterol; B. Smoking; C. Lack of exercise; D. All of the above. Explanation: High blood pressure and high cholesterol, smoking, and lack of exercise are contributors to heart disease, but it is necessary to include: diabetes and prediabetes, being overweight or obese, a diet high in fats, emotional stress, and excessive alcohol consumption as well as uncontrollable risk factors such as age, gender, and family history. The correct answer is: D. All of the above

 

 

Q7: In the heart, a clogged artery causes a heart attack. In the brain it causes a ___________.

 

A. Migraine; B. Mental illness; C. Stroke; D. Seizure

 

Explanation: A stroke occurs when blood flow to a part of the brain is interrupted because a blood vessel in the brain has been blocked. This is called an ischemic stroke. Cerebral hemorrhagic strokes occur when a blood vessel in the brain ruptures and bleeds into the surrounding brain tissue. The correct answer is: C. Stroke

 

 

Q8: When heart trouble is sensed, who waits at least two hours before help is called?

 

A. Men; B. Women; C. Both men and women; D. Children

 

Explanation: When it comes to heart trouble, Americans (males and females) typically wait at least two hours before calling for help. Know the warning signs and always call 911 within 5 minutes of when symptoms begin because waiting may allow heart trouble to become much worse. The correct answer is: C Both men and women

 

 

Q9: The term “heart failure” means the heart has stopped working.

 

True or False

 

Explanation: The term “heart failure” does not mean the heart has “failed” or stopped functioning. It means the heart does not pump as well as it should. This then leads to salt and water retention, causing edema (swelling) and shortness of breath, which are the primary symptoms of heart failure. The correct answer is: False

 

 

Q10: People can be born with heart disease.

 

True or False

 

Explanation: People born with heart structure and function problems are said to have “congenital heart disease.” Congenital (present at birth) heart disease refers to abnormal heart development before birth. It is the most common type of birth defect. The correct answer is: True

 

 

Q11: Has heart disease ever been responsible for half of the deaths in America?

 

True or False

 

Explanation: By the late 1940s, cardiovascular disease was responsible for half of all U.S. deaths. Only six decades ago, we didn’t know what caused cardiovascular disease, and many Americans died of heart attacks in their 50s or 60s. The correct answer is: Yes

 

 

Q12: The most common type of heart disease in the U.S. is:

 

A. Coronary artery disease; B. Atrial fibrillation; C. Mitral valve prolapse; D. Arrhythmias

 

Explanation: Coronary heart disease is usually caused by a condition called atherosclerosis, the narrowing of coronary arteries by cholesterol deposits, called plaques. If the arteries narrow enough, blood supply to the heart muscle may be compromised (slowed down), and this slowing of blood flow to the heart causes pain, or angina. The correct answer is: A Coronary artery disease

 

 

Q13: The medical term for chest pain is _________________.

 

A. Angina; B. There is no medical term for chest pain; C. Flutter; D. Arrhythmia

 

Explanation: Angina is chest pain that is due to an inadequate supply of oxygen to the heart muscle. The correct answer is: A. Angina

Edgar Allan Poe (1809-1849) Poe’s Death: Rabies, Alcohol or What?

 

 

1848 daguerreotype of Poe

The annual “historical clinicopathological conference,” sponsored by Maryland’s Department of Veterans Affairs and the University of Maryland, is a fun meet where doctors of various stripes discuss how this or that famous person met his end. The organizer is Dr. Philip Mackowiak. A chosen doctor, called the “discussant,” presents the facts of a case to an audience of doctors and students, then delivers his or her diagnosis. A general chin-wag ensues.

These days, “it’s become such a major production and everybody knows it’s a historical clinicopathological conference,” Mackowiak says. “The exercise now is to figure out who the person is and come up with a diagnosis.” Doctors are presented with a hypothetical patient and a description of the symptoms and are asked to render a diagnosis.

The following shows how this group of physicians diagnosed the death of America’s first great writer, Edgar Allan Poe:

Edgar Allan Poe did not die drunk in a gutter in Baltimore but rather had rabies, a new study suggests.

The researcher, Dr. R. Michael Benitez, a cardiologist who practices a block from Poe’s grave, says it is true that the writer was seen in a bar on Lombard Street in October 1849, delirious and possibly wearing somebody else’s soiled clothes. But Poe was not drunk, said Dr. Benitez, an assistant professor of medicine at the University of Maryland Medical Center. “I think Poe is much maligned in that respect,” he added. The great writer entered Washington College Hospital comatose, Dr. Benitez said, but by the next day was perspiring heavily, hallucinating and shouting at imaginary companions. The next day, he seemed better but could not remember falling ill. On his fourth day at the hospital, Poe again grew confused and belligerent, then quieted down and died. That is a classic case of rabies, the doctor said. His study is in the September issue of The Maryland Medical Journal.

In the brief period when he was calm and awake, Poe refused alcohol and could drink water only with great difficulty. Rabies victims frequently exhibit hydrophobia, or fear of water, because it is painful to swallow.   There is no evidence that a rabid animal had bitten Poe. About one-fourth of rabies victims reportedly cannot remember being bitten. After an infection, the symptoms can take up to a year to appear. But when the symptoms do appear, the disease is a swift and brutal killer. Most patients die in a few days.

Poe “had all the features of encephalitic rabies,” said Dr. Henry Wilde, who frequently treats rabies at Chulalongkorn University Hospital in Bangkok, Thailand. Although it has been well established that Poe died in the hospital, legend has it that he succumbed in the gutter, a victim of his debauched ways. The legend may have been fostered by his doctor, who in later years became a temperance advocate and changed the details to make an object lesson of Poe’s death. The curator of the Edgar Allan Poe House and Museum in Baltimore, Jeff Jerome, said that he had heard dozens of tales but that “almost everyone who has come forth with a theory has offered no proof.” Some versions have Poe unconscious under the steps of the Baltimore Museum before being taken to the hospital. Other accounts place him on planks between two barrels outside a tavern on Lombard Street. In most versions, Poe is wearing someone else’s clothes, having been robbed of his suit. Poe almost surely did not die of alcohol poisoning or withdrawal, Mr. Jerome said. The writer was so sensitive to alcohol that a glass of wine would make him violently ill for days. Poe may have had problems with alcohol as a younger man, Mr. Jerome said, but by the time he died at 40 he almost always avoided it.

Dr. Benitez, who worked on Poe’s case as part of this clinical pathologic conference. said that at first he did not know that he had been assigned Poe, because his patient was described only as “E. P., a writer from Richmond.” But by the time he was scheduled to present his findings a few weeks later, he had figured out the mystery.

Editor’s Note: Just to enrich your experience with History of Medicine, this week, take a listen to one of Poe’s greatest short stories.

The Tell Tale Heart by Edgar Allan Poe, narrated by James Mason

Five More Pharmaceutical Companies Join NIH Initiative to Speed Therapeutic Discovery

 

Five additional pharmaceutical companies have joined a National Institutes of Health-led effort to help in the research of promising new treatments. Funding and molecular compound information is available now for the initial phase of the recently unveiled Discovering New Therapeutic Uses for Existing Molecules program. This NIH-industry collaboration will match researchers with 58 compounds to test ideas for new therapeutic uses. Since the launch of the program last month, the total number of compounds the companies are making available has more than doubled.

 

Abbott, Bristol-Myers Squibb Company, GlaxoSmithKline, Janssen Pharmaceutical Research & Development, L.L.C., and Sanofi have joined Pfizer, AstraZeneca, and Eli Lilly and Company in this innovative approach to research.

 

The NIH’s new National Center for Advancing Translational Sciences (NCATS) created the Therapeutics Discovery program to help re-engineer the research pipeline. By crowdsourcing compounds that already have cleared several key steps in the development process, including safety testing in humans, scientists nationwide have the opportunity to contribute their expertise to advancing these resources for new disease therapies.

 

The eight participating companies will provide their compounds and related data, which were determined by the NIH to meet specific eligibility criteria. For example, each compound must have advanced to clinical studies but been unsuccessful in its original therapeutic indication or not pursued for business reasons. Preliminary information about the compounds, including mechanism of action, route of administration, and any limitations in use based on safety and tolerability, are available.

 

For the pilot phase of the program, in fiscal year 2013, NCATS will provide up to $20 million to fund two- to three-year staged, cooperative agreement research grants. If specific milestones are met, funded researchers will conduct pre-clinical validation and clinical feasibility studies in the first stage, and proof-of-concept clinical trials in the second stage, to test whether one of the compounds may be effective against a previously unexplored disease target. The pilot phase also is intended to test the utility of the newly created template agreements by reducing the negotiation time that otherwise could delay the research.

 

Researchers who are interested in NCATS’ Therapeutics Discovery funding must submit a pre-application in response to the NIH Funding Opportunity Announcement by Aug. 14, 2012. Applicants must include details about how they would explore specific hypotheses related to one of the compounds that might be useful in a specific disease area. The pre-applications will undergo review by external experts, and while no funding will be provided at this stage, successful applicants will be notified to submit a full application for fiscal year 2013 funding.

The Effects of Lowering LDL Cholesterol With Statin Therapy In People at Low Risk of Vascular Disease: Meta-Analysis of Individual Data From 27 Randomized Trials

 

Cholesterol Calculation: 1 mmol/l = 38.7 mg/dl

 

Statins reduce LDL cholesterol and prevent vascular events, but their net effects in people at low risk of vascular events remain uncertain. As a result, a study published in The Lancet, Early Online Publication (17 May 2012), evaluated, via a meta-analysis, individual participant data from 22 trials of statin versus control (n=134,537; mean LDL cholesterol difference 1.08 mmol/L (42 mg/dL); median follow-up 4.8 years) and five trials of more versus less statin (n=39,612; difference 0.51 mmol/L; 5.1 years).

 

Major vascular events were major coronary events (ie, non-fatal myocardial infarction or coronary death), strokes, or coronary revascularizations. Participants were separated into five categories of baseline 5-year major vascular event risk on control therapy (no statin or low-intensity statin) (<5%, >5% to <10%, >10% to <20%, >20% to <30%, >30%); in each, the rate ratio (RR) per 1.0 mmol/L LDL cholesterol reduction was estimated.

 

Results showed that reduction of LDL cholesterol with a statin reduced the risk of major vascular events (RR 0.79 per 1.0 mmol/L reduction), largely irrespective of age, gender, baseline LDL cholesterol or previous vascular disease, and of vascular and all-cause mortality. The proportional reduction in major vascular events was at least as big in the two lowest risk categories as in the higher risk categories, which reflected significant reductions in these two lowest risk categories in major coronary events (RR 0.57) and in coronary revascularizations (RR 0.52). For stroke, the reduction in risk in participants with 5-year risk of major vascular events lower than 10% (RR per 1.0 mmol/L LDL cholesterol reduction 0.76) was also similar to that seen in higher risk categories. In participants without a history of vascular disease, statins reduced the risks of vascular (RR per 1.0 mmol/L LDL cholesterol reduction 0.85) and all-cause mortality (RR 0.91), and the proportional reductions were similar by baseline risk. There was no evidence that reduction of LDL cholesterol with a statin increased cancer incidence, cancer mortality, or other non-vascular mortality.

 

According to the authors, in individuals with 5-year risk of major vascular events lower than 10%, each 1 mmol/L (39 mg/dL) reduction in LDL cholesterol produced an absolute reduction in major vascular events of about 11 per 1000 over 5 years. This benefit greatly exceeds any known hazards of statin therapy. Under present guidelines, such individuals would not typically be regarded as suitable for LDL-lowering statin therapy. The present report suggests, therefore, that these guidelines might need to be reconsidered.

Clinical Prediction of Fall Risk and White Matter Abnormalities: A Diffusion Tensor Imaging Study

 

The Tinetti scale is a simple clinical tool designed to predict risk of falling by focusing on gait and stance impairment in elderly persons. Gait impairment is also associated with white matter (WM) abnormalities. As a result, an article published in the Archives of Neurology (2012;69:733-738) was performed to test the hypothesis that elderly subjects at risk for falling, as determined by the Tinetti scale, have specific patterns of WM abnormalities on diffusion tensor imaging.

 

The study was performed in a community-based cohort of 125 homebound elderly individuals. The main outcome measure was dIffusion tensor imaging scans was the analysis of the location of WM abnormalities in subjects with Tinetti scale scores of 25 or higher (without risk of falls) and lower than 25 (with risk of falls). Multivariate linear least squares correlation analysis was performed to determine the association between Tinetti scale scores and local fractional anisotropy values on each skeletal voxel controlling for possible confounders.

 

Results showed that in subjects with risk of falls (Tinetti scale score <25), clusters of abnormal WM were seen in the medial frontal and parietal subcortical pathways, genu and splenium of corpus callosum, posterior cingulum, prefrontal and orbitofrontal pathways, and longitudinal pathways that connect frontal-parietal-temporal lobes. Among these abnormalities, those in medial frontal and parietal subcortical pathways correlated with Mini-Mental State Examination scores, while the other locations were unrelated to these scores.

 

According to the authors, elderly individuals at risk for falls as determined by the Tinetti scale have WM abnormalities in specific locations on diffusion tensor imaging, some of which correlate with cognitive function scores.

TARGET HEALTH excels in Regulatory Affairs. Each week we highlight new information in this challenging area.

 

Drug Shortages

 

What’s New on the FDA Drugs Site: June 13, 2012. Is there anything more to say?

EHRs – A Prescription for Pain Relief

 

 

By Mark L. Horn, MD, MPH, Chief Medical Officer, Target Health Inc.

 

A recent paper in the NEJM offers a welcome, interesting and potentially unifying explanation of the etiology of many common Electronic Health Records (EHRs) frustrations and happily provides an approach to address (at least) some of them. Perhaps what we need is a more diverse set of competitors and more creative regulation focused on facilitating interconnectivity and data access while bringing down costs. Ideally we’d have physicians and patients clamoring, and willing to pay for, truly innovative and cost effective EHR technology. One approach might be an EHR software targeted comparative effectiveness research (CER) initiative modeled on the patient focused outcomes research program assigned to the newly created Patient Centered Outcomes Research Institute (PCORI) by the Affordable Care Act (ACA).

 

Similar to, I suspect, many On-Target readers who have acquired familiarity with EHRs as either providers or patients, I’ve both experienced firsthand and heard secondhand about frustrations with these systems. The complaints are many and varied and include concerns about deficient capabilities, lack of ‘user-friendliness’, poor–or absent–communication among different systems (interoperability), unreliability, and expense.

 

According to a recently published paper by Kenneth Mandl and Isaac Kohane (NEJM 2012; 366:2240-42), medical information technology has actually regressed over time; initially ‘cutting edge’, the products have stagnated, especially in comparison to products available for other fields. These growing deficiencies have now reached the point where the technology physicians use in their professional lives lacks the sophistication and ease of use readily available among software applications used for many other purposes. They suggest (in a much truncated nutshell) that efforts by vendors to control data have restricted innovation and connectivity, damaging the market for innovative products and resulting in a suite of EHR products that has failed to capture for patients, physicians and the health care system the benefits of software advances, including the lower costs, available to them in (the authors’ term) their “civilian’ life”. The authors specifically note security processes, provider and patient communication, documentation tools, and the ability to perform sophisticated data analyses as areas where EHRs fail to incorporate the most powerful and available technologies.

 

Perhaps, given our readers’ collective interest in clinical development, we should add the ability to integrate physician and hospital generated clinical data with clinical trial data capture and analytic software to the list of potential opportunities. Compounding the frustration, the authors suggest that these superior technologies are likely available at costs below the price of EHR systems.

 

What is both interesting and ironic about this analysis is that physicians are often criticized for their failure to embrace technology; their seemingly slow and often grudging adaption of EHRs has been cited as evidence of this technological resistance. This criticism is perplexing since in other settings physicians are criticized for their overeager embrace of costly technologic interventions, among these advanced imaging techniques and robotic surgery. We may now have the seeds of a viable explanation. It may well be that physicians (and potentially patients as well) are more sophisticated than often assumed. As each cohort has gained experience with software products available for other purposes, perhaps they’ve discovered, relatively speaking, that EHRs often disappoint. Many available products lack critical functionality for interactivity, are excessively complex, difficult to use, and expensive.

 

Congress, Silicon Valley, and software developers everywhere, this is an interesting challenge for all.