Target Health is Presenting at the Society for Clinical Trials

 

Target Health is pleased to announce that the Society for Clinical Trials (SCT) Program Committee has accepted the abstract “Quantum Leap – Leveraging Real-time (Direct) Data-Entry to Increase Speed, Improve Quality, and Dramatically Reduce Costs” for oral presentation in a Contributed Paper Session at the 34th Annual Meeting of the Society for Clinical Trials. The meeting will take place May 19-22, 2013 at the Sheraton Boston Hotel in Boston, Massachusetts, USA.

 

Dean Gittleman, Sr. Director of Operations, will present during the Session on Current Monitoring Practices on Wednesday, May 22 from 8:00 AM – 9:30 AM.

 

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

 

Probiotics Found to Reduce Hepatic Encephalopathy

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Lactobacillus acidophilus

 

 

Probiotics are live microorganisms (e.g., bacteria) that are either the same as or similar to microorganisms found naturally in the human 1) ___ and may be beneficial to health. Also referred to as “good bacteria” or “helpful bacteria,” probiotics are available to consumers in oral products such as dietary supplements and yogurts, as well as other products such as suppositories and creams. The FDA has not approved any health claims for probiotics. This article provides a general overview of probiotics, with an emphasis on oral products, and suggests sources for additional information. The NIH is funding studies that involve probiotics.

 

According to a European study completed in April 2013, probiotics could emerge as a treatment plan to manage hepatic encephalopathy (HE) therapy after a new study announced at the International Liver Congress™ 2013 found they significantly reduced development of the notoriously difficult-to-treat 2) ___. The study analyzed the efficacy of probiotics in preventing the development of HE in 160 cirrhotic patients over a period of approximately nine months and found significant improvements in reducing patients’ arterial ammonia levels after three months of treatment with 3) ___.

 

Ammonia, produced by gut bacteria, is thought to be one of the main mediators of cerebral dysfunction in HE. Probiotics work by enriching the 4) ___ flora with a non-urease producing microorganisms, which decrease ammonia production. Probiotics are live microorganisms (mostly bacteria) that produce a health benefit on the host when administered in adequate amounts. Twice as many patients taking a 5) ___ developed overt HE (the study’s primary endpoint) compared to patients taking probiotics in the form of a capsule.

 

European Association for the Study of the Liver, (EASL’s) Treasurer, Prof. Mauro Bernardi welcomed the findings and said they would provide a positive impact for cirrhotic patients at risk of developing HE for whom the prognosis is typically very 6) ___. Prof. Bernardi said: “Hepatic encephalopathy is an insidious disease that’s caused by an accumulation of toxins in the blood that are normally removed by the 7) ___. Treatment normally involves the use of 8) ___ or laxatives to suppress the production of toxic substances in the intestine but there is still a great deal of room for improvement so it will be exciting to see the results of further studies to determine if clinicians have a new form of treatment on the cards.”

 

Hepatic encephalopathy is a spectrum of neuropsychiatric abnormalities including personality changes, intellectual impairment and reduced levels of consciousness in patients with liver 9) ___, after exclusion of other known brain disease.

 

ANSWERS: 1) body; 2) disease; 3) probiotics; 4) gut; 5) placebo; 6) poor; 7) liver; 8) antibiotics; 9) failure

 

Shakespeare’s Extensive Knowledge and Awareness of Disease (1564-1616)

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We celebrated William Shakespeare’s birthday on April 26th

 

 

William Shakespeare is widely regarded as a genius in the same category as Leonardo di Vinci, the grandfather of psychoanalysis, and the greatest writer in the English language and the world’s preeminent dramatist. His plays have been translated into every major living language and are performed more often than those of any other playwright. Part of Shakespeare’s genius lay in the breadth of his knowledge in so many fields. Including an impressive number of references to medical afflictions.

 

Below is a glossary of the medical terms used by Shakespeare in his plays, giving with some, the references and the actual or partial speeches. If you love the timelessness of Shakespeare, you’ll appreciate this. If you love the history of medicine, you’ll really get a kick out of the incredible awareness of Shakespeare, who was always ahead of the curve. And, if you have an interest in psychology and behavior, you will recognize his astuteness in including in his plays, all of the human aches and pains, knowing that his audience could easily identify with them, and subsequently be drawn in further to resonate with the deeper darker side of (all of us) our nature.

 

Ague – Fever usually caused by malaria characterized by chills and shivering, as well as pain in the joints and bones. Shakespeare refers to ague in nine plays.

 

In Julius Caesar, Caesar tells Caius Ligarius, “Caesar was ne’er so much your enemy as that same ague which hath made you lean”.

 

In King John, Constance – lamenting the fate of her son—says:

But now will canker-sorrow eat my bud

And chase the native beauty from his cheek

And he will look as hollow as a ghost,

As dim and meagre as an ague’s fit.”

 

References to ague also occur in Henry VIII, King Lear, Macbeth, The Merchant of Venice, Richard II, The Tempest, and Troilus and Cressida.

 

Alcoholism. Although Shakespeare does not use the word alcoholism, it is clear that certain characters in his plays exhibit symptoms of the disease, most notably Prince Hal’s drinking companions in Henry IV Part I and Henry IV Part II. Bardolph, for example, suffers from a bulbous red nose brought on by drinking malmsey, a Madeira wine. In the same two plays, Sir John Falstaff worships sack, a dry white wine, and even recommends addiction to it in the following prose passage: If I had a thousand sons, the first humane principle I would teach them should be, to forswear thin potations and to addict themselves to sack”. In Henry V, Falstaff cries out for sack on his deathbed.

 

Anxiety. Anxiety overtakes Macbeth after the First Murderer tells him that although Banquo lies dead in a ditch his son Fleance has escaped. Macbeth reacts with the following alliterative reply reflecting his anxiety: “But now I am cabin’d, cribb’d, confined, bound in.To saucy doubts and fears. But Banquo’s safe?”

 

Bed-Wetting. Shakespeare alludes to the condition in All’s Well That Ends Well when Parolles recites this prose passage: “For he will be swine-drunk; and in his sleep he does little harm, save to his bed-clothes about him; but they know his conditions and lay him in straw”.

 

Birthmark, or Nevus. In of King John, Constance praises her son, Arthur, as being fair-skinned and blessed with good looks, but notes that:

 

If thou wert grim,

Ugly and slanderous to thy mother’s womb

Full of unpleasing blots and sightless stains,

Lame, foolish, crooked, swart, prodigious

Patch’d with foul moles and eye-offending marks,

I would not care, I then would be content

For then I should not love thee.

 

Boil, or Furuncle. In Coriolanus, Marcius (Coriolanus) curses enemies, saying,

 

Boils and plagues

Plaster you o’er, that you may be abhorr’d

Further than seen and one infect another

Against the wind a mile!

 

Carbuncle. In King Lear, the old king rebukes one of his evil daughters, calling her “a boil, a plague-sore, an embossed carbuncle”.

 

Cramps. In The Tempest, when Caliban curses Prospero, Prospero replies with a curse of his own: “To-night that shalt have cramps / Side-stitches that shall pen they breath up”. A reference to cramps also appears in Shakespeare’s long poem The Rape of Lucrece: “The aged man that coffers-up his gold / Is plagued with cramps and gouts and painful fits”.

 

Epilepsy. In Julius Caesar, Cassius – in describing the great Caesar as a mere mortal, tells Brutus:

 

He had a fever when he was in Spain,

And when the fit was on him, I did mark

How he did shake: ‘tis true, this god did shake.

 

Hallucination. Macbeth presents one of the most famous depictions of a hallucination in all of literature, when Macbeth says:

 

Is this a dagger which I see before me,

The handle toward my hand? Come, let me clutch thee.

I have thee not, and yet I see thee still.

Art thou not, fatal vision, sensible

To feeling as to sight? or art thou but

A dagger of the mind, a false creation,

Proceeding from the heat-oppressed brain?

 

Macbeth also hallucinates when he sees the ghost of Banquo, who occupies Macbeth’s seat at a table during a banquet.

 

In Hamlet, Prince of Denmark, the ghost of the murdered king appears to Hamlet. But is it really a ghost or merely a hallucination? Shakespeare suggests the ghost really appears while presenting evidence indicating the contrary.

 

Headache. In King John, young Arthur – pleading with Hubert for mercy – recalls a time when he comforted Hubert, who was sick with a headache:

 

Have you the heart? When your head did but ache,

I knit my handercher about your brows,

The best I had, a princess wrought it me,

And I did never ask it you again;

And with my hand at midnight held your head,

And like the watchful minutes to the hour,

Still and anon cheer’d up the heavy time,

Saying, “What lack you?” and ‘Where lies your grief?”

 

Impotence. In Macbeth, a porter alludes to impotence when he tells Macduff that “drink” (alcoholic beverages) “provokes the desire, but it takes away the performance”.

 

Insomnia. In Macbeth, the First Witch promises in to inflict insomnia on a sailor, saying, “Sleep shall neither night nor day / Hang upon his pent-house lid”. After murdering King Duncan, Macbeth tells Lady Macbeth:

 

Methought I heard a voice cry ‘Sleep no more!

Macbeth does murder sleep’, the innocent sleep,

Sleep that knits up the ravell’d sleeve of care,

The death of each day’s life, sore labour’s bath,

Balm of hurt minds, great nature’s second course,

Chief nourisher in life’s feast.

 

When Macbeth confides to Lady Macbeth “Strange things I have in my head,” she replies, “You lack the season of all natures, sleep”.

 

Leprosy. Queen Margaret refers to the disease in Henry VI Part II:

Be woe for me, more wretched than he is.

What, dost thou turn away and hide thy face?

I am no loathsome leper; look on me.

 

Obsessive-Compulsive Disorder. Perhaps the most famous obsessive-compulsive character in all of literature is Lady Macbeth, the wife of the main character in Macbeth. Unable to banish her obsessive feelings of guilt, she repeatedly washes her hands to cleanse herself of culpability in the murder of King Duncan.

 

Pox (Syphilis). The word pox, for syphilis, occurs frequently in Shakespeare’s plays, attesting to the widespread occurrence of the illness in Elizabethan England. Characters in Shakespeare’s plays use pox mainly as a brief curse, like that uttered by Bertram against Captain Dumain – A pox upon him – in All’s Well That Ends Well. References to pox also occur in Cymbeline, Henry IV Part I, Henry IV Part II, Henry V, Hamlet, Love’s Labour’s Lost, Measure for Measure, Othello, and Pericles, Prince of Athens.

 

In Romeo and Juliet: Often quoted as “A pox on both your houses.” As Mercutio dies, he utters this phrase three times, cursing the families whose rivalry led to his death. The phrase is commonly applied to criticize warring factions whose rivalry brings ruin to others.

 

Rheumatism. In The Merry Wives of Windsor, Ann Page – in complimenting Sir Hugh Evans – describes the weather as conducive to rheumatism: “And youthful still! in your doublet and hose this raw rheumatic day!”. In Henry IV Part II, Mistress Quickly uses rheumatic in a simile when she addresses Falstaff and Doll Tearsheet: “By my troth, this is the old fashion; you two never meet but you fall to some discord: you are both, i’ good truth, as rheumatic as two dry toasts; you cannot one bear with another’s confirmities”.

 

Sleepwalking, or Somnambulism. In Act V, Scene I, of Macbeth, a gentlewoman reports to a doctor that Lady Macbeth has been sleepwalking: “Since his majesty went into the field, I have seen her rise from her bed, throw her night-gown upon her, unlock her closet, take forth paper, fold it, write upon’t, read it, afterwards seal it, and again return to bed; yet all this while in a most fast sleep”.

 

Source: Michael J. Cummings is the developer of Shake Sphere and its forerunner, The Complete Shakespeare. He has taught English composition and literature at the college level as an adjunct instructor. Over the years, he has written more than 3,000 articles and four books as a journalist and freelance writer. One of his writing specialties is medicine. 

Use of a Bacteriophage Lysin Antibody to Identify a Novel Target for Antimicrobial Development

 

Congratulations to our friend and colleague Dr. Allan Goldberg and his team from Rockefeller University for this breakthrough research.

 

Target selection is critical for the development of new antimicrobial agents. To date, most approaches for target selection have focused on the importance of bacterial survival. However, in addition to survival, according an article published in CPLoS ONE (10 April 2013), it is believed that molecular targets should be identified by determining which cellular pathways have a low probability for developing resistance.

 

The article identifies an essential cell wall biosynthetic enzyme that has been identified in Bacillus anthracis, as well as an inhibitor to which the organism did not spontaneously evolve measurable resistance.  This work is based on the exquisite binding specificity of bacteriophage-encoded cell wall-hydrolytic lysins, which have evolved to recognize critical receptors within the bacterial cell wall. Focusing on the B. anthracis-specific PlyG lysin, the authors first identified its unique cell wall receptor and cognate biosynthetic pathway. Within this pathway, one biosynthetic enzyme, 2-epimerase, was required for both PlyG receptor expression and bacterial growth.

 

Through the collaboration with Astex, initiated by co-author Allan Goldberg, an inhibitor of 2-epimerase named Epimerox was developed. Raymond Schuch, a former postdoctoral researcher in Fischetti’s lab at Rockefeller, tested the inhibitor in mice infected with Bacillus anthracis. He found that not only did Epimerox protect the animals from anthrax, but the bacteria did not develop resistance to the inhibitor. The researchers also found that Epimerox was able to kill methicillin-resistant Staphylococcus aureus (or MRSA) with no evidence of resistance even after extensive testing.

Vitamin D May Reduce Risk of Uterine Fibroids

 

Fibroids, also known as uterine leiomyomata, are noncancerous tumors of the uterus. Fibroids often result in pain and bleeding in premenopausal women, and are the leading cause of hysterectomy in the United States.

 

The body can make vitamin D when the skin is exposed to the sun, or vitamin D can come from food and supplements.

 

According to an article published in Epidemiology (2013;24:447-453), women who had sufficient amounts of vitamin D were 32% less likely to develop fibroids than women with insufficient vitamin D. The study included 1,036 women, aged 35-49, living in the Washington, D.C., area from 1996 to 1999. Study subjects were screened for fibroids using ultrasound and blood samples used to measure the primary circulating form of vitamin D, known as 25-hydroxy D. Those subjects with more than 20 ng/mL of 25-hydroxy D were categorized as sufficient, though some experts think even higher levels may be required for good health. Study participants also completed a questionnaire on sun exposure. Those who reported spending more than one hour outside per day also had a decreased risk of fibroids. The estimated reduction was 40%. Although fewer black than white participants had sufficient 25-hydroxy D levels, the estimated reduction in prevalence of fibroids was about the same for both ethnic groups.

Prenatal Valproate Exposure and Risk of Autism Spectrum Disorders and Childhood Autism

 

Valproate is used for the treatment of epilepsy and other neuropsychological disorders and may be the only treatment option for women of childbearing potential. As a result, a study published in the Journal of the American Medical Association (2013;309:1730-1731), was performed to determine whether prenatal exposure to valproate is associated with an increased risk of autism in offspring.

 

The investigation was a population-based study of all children born alive in Denmark from 1996 to 2006. National registers were used to identify children exposed to valproate during pregnancy and diagnosed with autism spectrum disorders (childhood autism [autistic disorder], Asperger syndrome, atypical autism, and other or unspecified pervasive developmental disorders). The risks associated with all autism spectrum disorders were analyzed as well as childhood autism. Children were followed up from birth until the day of autism spectrum disorder diagnosis, death, emigration, or December 31, 2010, whichever came first.

 

The main outcomes measures were absolute risk (cumulative incidence) and the hazard ratio (HR) of autism spectrum disorder and childhood autism in children after exposure to valproate in pregnancy.

 

Results showed that of 655,615 children born from 1996 through 2006, 5,437 were identified with autism spectrum disorder, including 2,067 with childhood autism. The mean age of the children at end of follow-up was 8.84 years (range, 4-14). The estimated absolute risk after 14 years of follow-up was 1.53% for autism spectrum disorder and 0.48% for childhood autism. Overall, the 508 children exposed to valproate had an absolute risk of 4.42% for autism spectrum disorder (adjusted HR, 2.9) and an absolute risk of 2.50% for childhood autism (adjusted HR, 5.2). When restricting the cohort to the 6,584 children born to women with epilepsy, the absolute risk of autism spectrum disorder among 432 children exposed to valproate was 4.15% (adjusted HR, 1.7), and the absolute risk of childhood autism was 2.95% (adjusted HR, 2.9) vs, 2.44% for autism spectrum disorder and 1.02% for childhood autism among 6,152 children not exposed to valproate.

 

According to the authors, maternal use of valproate during pregnancy was associated with a significantly increased risk of autism spectrum disorder and childhood autism in the offspring, even after adjusting for maternal epilepsy, and that for women of childbearing potential who use antiepileptic medications, these findings must be balanced against the treatment benefits for women who require valproate for epilepsy control.

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

 

FDA’s Dr. Russell Katz Honored for Research on Alzheimer’s

 

The following is based on an article written by Dr. Robert Temple, Deputy Director for Clinical Science in FDA’s Center for Drug Evaluation and Research, and posted on April 26, 2013 by FDA Voice.

 

Dr. Russell Katz, one of FDA’s leaders in the field of Alzheimer’s disease research and drug development has been nationally recognized for his contributions to combating this progressive and debilitating disease. Dr. Katz first joined FDA in 1983. Today, he is director of FDA’s Division of Neurology Products, the division that reviews and approves drugs for neurological conditions, including those for patients with Alzheimer’s disease. At its recent National Alzheimer’s Dinner, the Alzheimer’s Association awarded Dr. Katz the Ronald and Nancy Reagan Research Award, which honors researchers who are leading the way in promising and innovative approaches to Alzheimer’s treatment, prevention and care. Dr. Katz joins a distinguished list of past honorees from the Mayo Clinic, University of Virginia, Johns Hopkins University School of Medicine, Harvard Medical School, and many other outstanding organizations.

 

One in eight older Americans suffers from Alzheimer’s disease (AD), the sixth-leading cause of death in the United States. As Dr. Katz has noted, “The aging of the baby boomers is fueling what could turn a public health problem into a public health crisis.” According to estimates by the Alzheimer’s Association, if no treatments are developed to prevent, cure or slow the progression of AD, the number of Americans suffering from this pernicious disease will grow from 5.4 million to as many as 16 million by 2050.

 

Dr. Katz has been a critical figure in the advancement of research and drug development for Alzheimer’s disease, building strong partnerships in the Alzheimer’s community and strengthening the science needed to evaluate the safety and effectiveness of potential new drugs. He has been particularly instrumental in helping drug developers focus on ways to study drugs in the early stages of AD, and when there is hope that disease progression can be stopped or delayed before too much damage is done. With his colleagues he drafted an FDA “guidance” on conducting studies in early stages of AD. It addresses difficult questions, such as these: how do we select patients for clinical trials for early-stage AD drugs despite the fact that early stages of the disease are hard to diagnose? And how can we determine the effectiveness of a drug for early-onset AD when symptoms are difficult to define?

 

FDA is devoted to seeing new treatments for AD enter the development pipeline. According to Dr. Temple, no one has been more instrumental in helping to implement that vision than Dr. Katz and “we thank him for his dedication and hard work, and along with the Alzheimer’s Association, applaud him for all that he does to advance public health”.

Springtime Ribbon Salad

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Spring is when tender delicious asparagus is in season. You can buy the homegrown variety at most markets, right now. At this time of year, you don’t have to cook the asparagus at all; it’s so-o tender and crunchy, if you get it locally. This salad is easy and quick to make, All of the colors are beautiful together and this salad looks impressive all curled into ribbons.

 

Ingredients

 

1 zucchini, ends cut off, sliced thinly

1 yellow squash, ends cut off, sliced thinly

1 bunch asparagus (not thin stalks), shaved thinly

1 carrot, peeled and ends cut off, sliced thinly

1/4 cup pine nuts, toasted

  • Toast the pine nuts in a single layer on a baking sheet at 350 degrees, for 5 to 10 minutes. It’s really important, especially with pine nuts, that you stay near the oven and toss them a lot or they will burn.

1/4 cup extra-virgin olive oil

2 Tablespoons fresh.lemon juice

Pinch salt

1/4 teaspoon freshly ground black pepper (or grind to your taste)

2+ ounces freshly grated Parmesan

 

Directions

 

Wash your veggies well and make sure that your vegetables are nice and dry before trying to slice or shave them. Otherwise, you could accidentally slip and cut your hand with the mandoline or vegetable peeler! Feel free to hold them in one hand with a towel, while peeling with your other hand.

 

Using a mandoline, carefully slice, lengthwise, the zucchini, squash, and carrot into long thin strips (“ribbons”).

 

Don’t snap off the tough ends of your asparagus; you need to hold onto these tough ends, in order to peel the rest of the asparagus spear.

 

Lay a single asparagus stalk on its side, on a cutting board. Holding onto the tough end, use a vegetable peeler (a Y-shaped peeler is easiest, but a standard one is okay), to shave off thin asparagus ribbons from stalk to tip. From bottom to top. Obviously, when done, throw away the tough ends. Also, don’t worry if the tender tip or part of it, remains with one of the slices; it’ll make your salad look that much more interesting and will taste good too.

 

Gently pile your ribbons on a serving platter or in a salad bowl. Add salt (optional) and grind the pepper to your taste. Squeeze the fresh lemon juice over the veggie ribbons, and drizzle them with the extra virgin olive oil. Toss gently

 

Now use your peeler to shave curls of Parmesan right off the block or grate the cheese (I like to grate it) and add to the ribbon salad. Sprinkle with the toasted nuts** Toss the salad and serve.

 

You can serve this beautiful Spring salad with any fish you desire, say, an easy to bake salmon fillet with baked sweet potatoes or jasmine rice or both, for a low calorie, very healthy repast. We drink mainly white wine, because recently red wine, which we love, caused palpitations, whereas white does not. Here are some wines that would go well with the baked salmon and the ribbon salad: Pinot Noir, Sauvignon Blanc, Pinot Gris, Sémillon, Vin Gris. Whatever you decide, enjoy!

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Enjoy!

 

You may have noticed that ribbon salads are especially popular in restaurants during the Spring and Summer. I think I’ve had this type of salad at Union Square Café and Gramercy Tavern, here in Manhattan. Below are some variations on this wonderful salad. Because, the asparagus is unbelievably tender right now, you might want to consider asparagus ribbons only, for your salad.

 

Asparagus Ribbon Salad with Lemon and Parmesan

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Ingredients

1/4 cup pine nuts or sliced almonds, toasted* (and more if you wish)

1 pound asparagus, rinsed (don’t use the tough ends)

1 lemon, halved (go by your own taste and squeeze accordingly)

Olive oil

pinch of Kosher salt (optional)

Pinch, Fine black pepper

1 to 2 ounces freshly grated Parmesan cheese (add more according to your taste)

 

Directions

 

Rinse the asparagus but don’t snap off the tough ends; because you need to hold onto the tough ends, in order to peel the rest of the asparagus spear.

 

Lay a single stalk on its side on a cutting board. Holding onto the tough end, use a vegetable peeler (a Y-shaped peeler is easiest, but a standard one is okay), to shave off thin asparagus ribbons from stalk to tip, from bottom to top. Shave thin ribbons from all the asparagus spears.

 

Pile the ribbons in a salad bowl. Squeeze the lemon juice over the asparagus and then drizzle it with the olive oil and sprinkle the black pepper (grind to your taste). Toss the ribbons gently. Use the veggie peeler to shave curls of Parmesan, or grate this cheese and sprinkle it over the asparagus (I prefer grating it). Finally, add your toasted nuts.

  • Toast in a single layer on a baking sheet at 350 degrees, for 5 to 10 minutes. It’s really important, especially with pine nuts and/or sliced almonds, that you stay near the oven and toss them a lot or they’ll burn.

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Variation using sesame seeds instead of pine nuts

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Variation using hazelnuts and arugula with asparagus ribbons

 

 

PUBLIC POLICY – Whither the Electronic Health Record (EHR) – An Individual Doctor’s Dilemma

Whither the Electronic Health Record (EHR) – An Individual Doctor’s Dilemma

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

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Target Health is Co-Presenting at BIO on a Panel on Risk-Based Monitoring

 

Dr. Jules T. Mitchel will be presenting at a Panel at the BIO International Convention in Chicago (April 22-25). The panel is entitled Clinical Trials Modernization: The Promises and Challenges of Risk-Based Approaches to Monitoring, and will be held on April 24 at 10:30 am in Building: S401A (Session ID: 1983). Other speakers include James Dixon Senior Vice President, Global Quality & Compliance PPD, Inc. and Ann Meeker-O’Connell Acting Division Director, Good Clinical Practice Compliance CDER, US Food and Drug Administration.

 

Session Description: Monitoring the progress of clinical investigations typically involves frequent visits to each study site. However, general guidelines for Good Clinical Practice (GCP), FDA regulation, and International Conference on Harmonization (ICH) guideline E6 actually provide substantial latitude regarding the extent and nature of clinical trial monitoring. Newer risk-based approaches that leverage centralized data monitoring through electronic data capture systems can lead to significant efficiencies for clinical trial sponsors. A panel representing industry sponsors of clinical research, clinical research organizations, and regulatory authorities will present their current thinking and strategies to streamline study oversight.

 

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

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