Category Archives: Clinical Research

Adding Friendly Bacteria to Skin Lotion Wards Off Bad Germs

Customized creams guarded five patients with a kind of itchy eczema against risky bacteria that were gathering on their cracked skin.

Bacteria live on everyone’s skin, and new research shows some friendly germs produce natural antibiotics that ward off their disease-causing cousins. Now scientists are mixing the good bugs into lotions in hopes of spreading protection. In one early test, those customized creams guarded five patients with a kind of itchy eczema against risky bacteria that were gathering on their cracked skin, researchers reported.

Image courtesy of Shutterstock

“It’s boosting the body’s overall immune defenses,” said Dr. Richard Gallo, dermatology chairman at the University of California, San Diego, who is leading the work.

We share our bodies with trillions of microbes that live on our skin, in our noses, in the gut. This community  – what scientists call the microbiome  – plays critical roles in whether we stay healthy or become more vulnerable to various diseases. Learning what makes a healthy microbiome is a huge field of research, and already scientists are altering gut bacteria to fight diarrhea-causing infections.  The research sheds new light on the skin’s microbiome, suggesting that one day it may be possible to restore the right balance of good bugs to treat skin disorders, too.

Healthy skin harbors a different mix of bacteria than skin damaged by disorders such as atopic dermatitis, the most common form of eczema. Those patches of dry, red, itchy skin are at increased risk of infections, particularly from a worrisome germ known as Staphylococcus aureus.

Gallo’s team took a closer look at how microbes in healthy skin might be keeping that bad staph in check.  They discovered certain strains of some protective bacteria secrete two “antimicrobial peptides,” a type of natural antibiotic. In lab tests and on the surface of animal skin, those substances could selectively kill Staph aureus, and even a drug-resistant strain known as MRSA, without killing neighboring bacteria like regular antibiotics do, the team reported in the journal Science Translational Medicine.

But those good bugs are rare in the skin of people with atopic dermatitis, Gallo said.  “People with this type of eczema, for some reason that’s not quite known yet, have a lot of bacteria on the skin but it’s the wrong type of bacteria. They’re not producing the antimicrobials they need,” he explained. Would replenishing the good bugs help? “They’re normal skin bacteria, so we knew they would be safe,” Gallo noted.

His team tested five volunteers with atopic dermatitis who had Staph aureus growing on their skin’s surface  – what’s called colonization, but didn’t have an infection. Researchers culled some of the rare protective bacteria from the volunteers’ skin, grew a larger supply and mixed a dose into an over-the-counter moisturizer. Volunteers had the doctored lotion slathered onto one arm and regular moisturizer on the other.

A day later, much of the staph on the treated arms was killed – and in two cases, it was wiped out, compared to the untreated arms, Gallo said.  “We’re encouraged that we see the Staph aureus, which we know makes the disease worse, go away,” he said.

The study couldn’t address the bigger question of whether exposure to the right mix of protective bacteria might improve atopic dermatitis itself, cautioned Mount Sinai’s Guttman-Yassky. Next-step clinical trials are underway to start testing effects of longer-term use.

Source: By Lauran Neergaard, AP, Displayed with permission from STAT via RePubHub

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This Is Why Red Peppers Could Reduce Lung Cancer Risk In Smokers

In a new study, researchers from Tufts University in Massachusetts have uncovered the molecular reasoning for beta-cryptoxanthin pigment’s powerful cancer-fighting skills.

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Red Bell Peppers — Image courtesy Pexels PIXABAY CC0 Lic

Researchers discovered in 2004 that beta-cryptoxanthin (BCX), a natural pigment which gives many fruits and vegetables their bright red and orange colorings, was able to reduce smokers’ risk of developing lung cancer — although exactly why remained unclear.

Tufts cancer researcher Xiang-Dong Wang and his team found that BCX has the opposite effect of nicotine on lung cells in mice and is able to decrease erratic cell growth in the lung and limit the cancer from spreading. While more research is needed, Wang predicts that understanding BCX’s effect on lung cells could lead to new chemoprevention techniques and could be implemented in dietary recommendations for patients undergoing lung cancer treatment, and for lung cancer survivors.

Read More:  3 Reasons Why Non-Smokers Get Lung Cancer

“For smokers, tobacco product users or individuals at higher risk for tobacco smoke exposure, our results provide experimental evidence that eating foods high in BCX may have a beneficial effect on lung cancer risk,” said Wang in a statement.

Nicotine binds to lung cells, triggering a biochemical response that may lead to erratic cell growth, and new blood vessel development — the perfect storm for lung cancer. However, Wang and his team discovered that BCX is able to counteract this response by inhibiting lung cell growth and preventing cancer cells from spreading to different parts of the body.

In the study, the team observed that mice that had purposely been given a nicotine-derived carcinogen, and which were treated with BCX had fewer lung tumors than those who were not given BCX. According to Wang, the greatest benefit in mice was equivalent to a daily human dose of about 870 micrograms, or the amount contained in one sweet red pepper or a couple of tangerines a day. Also, human lung cancer cells in a petri dish treated with BCX migrated less than those that were not.

The researchers emphasized that their study does not show that BCX has the ability to prevent or cure lung cancer in humans. Still, the results are promising and the team hope to take their research further to better understand the cancer-killing capabilities of red and orange fruits and veggies.

Source: WAng XD, Iskandar AR, Miao B, et al. β-Cryptoxanthin Reduced Lung Tumor Multiplicity and Inhibited Lung Cancer Cell Motility by Downregulating Nicotinic Acetylcholine Receptor α7 Signaling.  Cancer Prevention Research .2016

By Dana Dovey; Displayed with permission from Medical Daily via RePubHub

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New Study Shows Spinal Cord Stimulation Reduces Opioid Use For Chronic Pain

ONE YEAR AFTER IMPLANT, 93 PERCENT OF PATIENTS WHO CONTINUED SCS THERAPY HAD LOWER AVERAGE DAILY MORPHINE-EQUIVALENT DOSES THAN PATIENTS WHO HAD THEIR SCS SYSTEM REMOVED

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Image courtesy of geralt CC0 PIXABAY

New research has found spinal cord stimulation (SCS) therapy can be key to reducing or stabilizing the use of opioids in patients battling chronic pain. In a new study, researchers examined opioid usage data from more than 5,400 patients both prior to and after receiving an SCS system implant. In an SCS system, an implanted device similar to a pacemaker delivers low levels of electrical energy to nerve fibers, interrupting pain signals as they travel to the brain to reduce the sensation of pain. Researchers have found that average daily opioid use declined or stabilized for patients receiving a successful SCS system compared to patient use of opioids prior to an implant.

In addition, while opioid usage was not different for the two groups at time of implant, patients who underwent a successful SCS implant had significantly lower opioid use one year after their implant. Patients who had their SCS system removed saw their opioid use increase again over time.

In 5,400-patient study, average daily opioid use declined or stabilized in patients receiving SCS system, while patients who had SCS system removed had higher opioid use over time.  The study, which the researchers believe makes a compelling case for considering SCS therapy earlier in the chronic pain care continuum, were presented at the 2017 North American Neuromodulation Society (NANS) annual meeting by Ashwini Sharan, M.D., director of Functional and Epilepsy Surgery at Vickie and Jack Farber Institute for Neuroscience at Jefferson and president of NANS.  The study was sponsored by Abbott (NYSE: ABT), a global leader in the development and manufacture of SCS systems and therapy options, such as the company’s proprietary BurstDR™ stimulation.

Currently, more than 2.1 million people in the U.S. suffer from substance abuse related to opioid pain relievers, while worldwide an estimated 15.5 million people are now classified as opioid dependent. Chronic pain is often a driver of opioid use as patients seek relief and improvements to their quality of life. Fortunately for patients, SCS therapy has been clinically proven to offer meaningful relief to patients suffering from chronic pain.  There is potential to improve outcomes by implanting SCS systems earlier, before chronic opioid use, according to authors.

“Given the epidemic of opioid addiction and abuse, these findings are important and confirm that spinal cord stimulation therapy can offer strong benefits for patients struggling with chronic pain,” said Sharan. “Based on these results, we concluded it may be possible to improve outcomes by offering our patients spinal cord stimulation earlier, before opioid dependence and addiction can occur.”

ABOUT THE STUDY:
For their analysis, the research team assessed private and Medicare insurance claims data from 5,476 patients who received an SCS system to treat chronic pain associated with a host of conditions (excluding pain related to cancer). The data were collected between January 2010 and December 2014. The data confirmed that many patients are often prescribed increasing dosages of opioids prior to receiving an SCS system. The researchers also found:
• SCS therapy is effective for patients at any level of opioid usage prior to implantation.
• Opioid use declined or stabilized in 70 percent of patients who received an SCS system.
• Among patients who had their SCS system explanted, opioid use was higher at one year compared to those who continued with SCS therapy.

The researchers further suggested patient outcomes could be improved if SCS were implanted earlier in recognition of the clinical practice to provide increasing dosages of opioids over time. These conclusions help build upon prior research, such as results of a large multicenter randomized controlled trial in patients with failed back surgery syndrome (FBSS) that showed trends in opioid reduction or cessation among SCS patients. In addition, new technologies released in the U.S. in 2015 and 2016 hold promise to improve outcomes further and may reduce common complications resulting in explant such as the undesired changes in paresthesia, issues with charging, pain at the implantable pulse generator (IPG) site, and loss of pain relief.

SOURCE: Displayed with permission from PRNewswire for Journalists

Ingredient In Red Bull Helps Treat Psychotic Episodes

Many of us have relied on energy drinks like Red Bull or Monster to pull all-nighters in college, alleviate hangovers, or as a pick-me-up before hitting the gym. These 20-ounce sugar-laden drinks are not the healthiest beverages to consume, but researchers now suggest they may possess medicinal properties. A study presented at the annual meeting of the International Early Psychosis Association found taurine, an additive in energy drinks, can significantly help with psychosis.

angel-wings-305131_640 FREE USE CC00 PIXABAY

Image courtesy PIXABAY CC00 Lic

“Although taurine supplementation did not improve cognition, it appears to improve core symptoms and depression in patients with FEP,” concluded the authors. (FEP is an individual’s first episode of psychosis.)

Taurine is a naturally occurring amino acid in the body that aids a variety of functions. It helps control cardiovascular function, and has been found to both protect the paths of neurons in the brain, and help stimulate the creation of new neurons via neurogenesis. The amino acid is also known to have a calming effect on the brain.

Keeping this in mind, the team of researchers sought to observe if taurine could be utilized to stabilize the neurological activity occurring in people experiencing their first episode of psychosis. A total of 86 participants, aged 18 to 25, who had been previously diagnosed as suffering from a mental disorder with psychosis as a symptom, were recruited for the study. Every day for 12 weeks, half of the participants got four grams of taurine along with their antipsychotic medication, while the other half got a placebo.

Signs of early or FEP include hearing, seeing, tasting or believing things that others don’t; sudden decline in self-care; and trouble thinking clearly or concentrating, according to the National Alliance on Mental Illness. These warning signs often point to a person’s deteriorating health, requiring a physical and neurological evaluation to help identify the problem. The severity of the participants’ symptoms was measured using the Brief Psychiatric Rating Scale (BPRS) and the Calgary Depression Scale for Schizophrenia (CDSS). The researchers also used a scale called the MATRICS consensus cognitive battery (MCCB) to measure changes in cognition.

After 12 weeks, those who received taurine has significantly improved scores on the BPRS, indicating a reduction in psychotic symptoms. They also experienced a significant decrease in depression, although there were no notable changes in cognition. The researchers suggest taurine could potentially act as an effective nutritional therapy in treating FEP.  However, they caution: “The use of taurine warrants further investigation in larger randomised studies, particularly early in the course of psychosis.”  Previous research supports taurine’s ability to aid symptoms in mental disorders. Its been used as an alternative to lithium, by blocking the effects of excess acetylcholine that contributes to bipolar disorder.

Researchers are still a long ways away from prescribing taurine to help with psychosis. It clear that the substance could potentially play an influential role in treating mental illness. But the dose used in the experiment is equivalent to drinking about four 250-millimeter cans of Red Bull in one sitting every day: This is not recommended, and for most people, it’s likely to lead to more problems than it would solve.

Source: Trial finds Red Bull additive taurine improves symptoms of young people suffering first episode psychosis. International Early Psychosis Association Meeting in Milan, Italy. 2016.

By Lizette Borreli, Displayed with permission from Medical Daily
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Scientist Helps NASA Develop Medical Device

In the future, NASA astronauts journeying into deep space may give themselves a health check-up with the aid of a small medical device developed by a team of scientists, including one from LLNL.

Laboratory radiobiologist Matt Coleman is part of the six-scientist team, including researchers from NASA’s Ames Research Center, the University of California, Davis and Sandia National Laboratories/California, that has developed a small, portable medical diagnosis instrument. The team members have filed for a patent for their medical device.

NASA MColeman Med Device

Radiobiologist Matt Coleman displays a device like the medical diagnosis instrument he helped develop for NASA for use in deep space. | Photo by Lawrence Livermore National Laboratory.

The patent covers the development of a comprehensive in-flight medical diagnostic system in a hand-held format weighing less than one pound for human deep-space missions such as a mission to Mars, which is expected to take six months each way.

 

 

 

“The point of developing tools like this one is for detecting disease from long-term exposure to microgravity and ionizing radiation,” Coleman said, adding that exposures from space exploration can potentially cause degenerative diseases of the bone, heart and eye, along with raising concerns about cancer.  “Since we don’t fully understand the long-term impacts of space travel, there has been a push by NASA to better understand these effects.”

The new medical device will use biomarkers in three different sample types – breath, saliva and blood – to detect information that is indicative of health and exposure to radiation. (A biomarker is any protein, DNA, RNA or small molecules that provide information about current or future health status).

Breath and saliva are non-invasive samples and can rapidly provide health assessment information, which can be critical immediately following space walks, and prior to removal of any spacesuits.

Key features of the device include the ability to handle multiple sample types and the ability to measure virtually any biomarker, including future biomarkers as they emerge. Small blood samples can provide information about macromolecular biomarkers as well as blood cell counts.  “Some of the tools we’re developing will be among the first multi-function health diagnostic devices used in space,” Coleman said.

The team conceptualized the device in 2012 and wrote a paper about its development that appeared in 2013 in the journal, Recent Patents in Space Technology. The team has built a conceptual mock-up of the portable medical device and its individual technologies have been tested.

The team’s lead scientist is Tore Straume of NASA’s Ames Research Center, a former LLNL researcher and Lab retiree. Straume is a radiobiologist, conducting research that focuses on the effects of ionizing radiation on human health. In addition to Coleman and Straume, the team includes David Loftus and Jing Li of NASA Ames, Cristina Davis of UC Davis and Anup Singh of Sandia National Laboratories/California.

By Stephen Wampler | Lawrence Livermore National Laboratory; Displayed with permission from Breaking Energy

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IMMUNO-ONCOLOGY: Targeting the immune system, not the tumor

Immuno-oncology is based on the concept of harnessing the body’s own immune system to fight cancer.

One of the most exciting areas of cancer research today is immuno-oncology, and while it’s an approach that scientists first considered more than 100 years ago, recent scientific discoveries and clinical advances have ushered in a truly historical time in cancer research.

Immuno-oncology Video Capture

Image Courtesy of PhRMA (Video Capture)

Recently, PhRMA released a new video highlighting immuno-oncology, which is currently being researched and developed by Bristol-Myers Squibb and several other bio-pharmaceutical companies.

Cancer is clever and has found ways to outwit the immune system. Rather than killing these cancer cells directly with traditional tools like radiation or chemotherapy, immunotherapy seeks to intensify the immune system’s power to eliminate them. Immuno-oncology is already improving outcomes and survival rates for some patients, including melanoma, kidney and lung cancer, and researchers are urgently working to gain new insights into the complex interactions between patients’ immune systems and the cancer cells growing in their bodies with the goal of markedly improving outcomes in many more tumor types.

While the science has advanced rapidly in recent years, there is more work to do. Researchers hope to replace chemotherapy as the first line treatment for many cancers and help as many patients as possible achieve long-term survival. This new treatment approach has the potential to help patients live longer, healthier lives.

Learn more about advancements in science at From Hope to Cures.

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New Drug Holds Promise Against Zika

MV-4 Based On Research That Unlocks Key to Breaking Down Viruses

A New York pharmaceutical company, TGV-Laboratories, says it has unlocked the key for breaking down the protective barriers of viruses, a breakthrough that it believes can be developed into antiviral drugs to treat Zika and host of life-threatening viruses, including Ebola, HIV and Bird Flu.  The company’s lead researchers, Victor and George Tetz, said lab tests show their discovery, called MV-4, can break down the protective barriers of both enveloped and non-enveloped viruses, indicating it can be developed into targeted synthetic antiviral drugs to kill a wide variety viruses.

ZIKA Virus WordleArtIn laboratory tests, the researchers said they were able to kill influenza viruses, HIV, Herpes viruses, polio and adenoviruses, and are eager to test their discovery against Zika, Ebola and Bird Flu.  In a letter to the CDC, the researchers outlined their findings, and offered their help in developing new treatments against these global health threats.

“We are very excited about our findings to date, and are eager to expand the testing of our drugs on these dangerous and highly contagious viruses,” said Victor Tetz, scientific head of TGV-Laboratories. The Zika virus is primarily a mosquito-transmitted infection. However, it was recently isolated from semen, and there is evidence it can be transmitted through sexual intercourse — opening new frontiers for global spreading and raising the need for an antiviral drug that can attack it at many levels. “The studies we have conducted to date show MV-4 can inactivate viruses in the outer environment, on human skin and at intravenous administration, so we believe discovery shows huge promise against Zika, Ebola and Bird flu.”

TGV Laboratories, along with its Institute of Human Microbiology, are finalizing a paper that details their discovery and what they believe to be its strong potential for safely treating a broad range of life-threatening and non-life threatening viruses. Currently, there are no broad-spectrum antiviral drugs.  MV-4 is the second broad-spectrum drug candidate developed by TGV Laboratories, whose Mul-1867 has shown potential for being developed into drugs that can treat an extensive range of antibiotic-resistant bacterial and fungal infections. TGVs subsidiary, TGV-Inhalonix, recently filed an application with the Food and Drug Administration seeking Orphan Drug Status for Mul-1867 to be tested on cystic fibrosis patients with life-threatening antimicrobial-resistant pulmonary infections.

“Developing broad-spectrum drugs that can treat viruses and the growing list of antibiotic-resistant infections is one of the most important, but elusive, goals in infectious research today,” said George Tetz, head of research for the Institute of Human Microbiology. “With MV-4 and Mul-1867, we believe we have unlocked the key for developing the next-generation of antibiotics and anti-viral drugs.”

The drugs in TGV’s pipeline were discovered as the result of years of research by Victor and George Tetz using a new concept they developed called Pangenome, (http://www.ncbi.nlm.nih.gov/pubmed/15990697), which acts like a guide that helps mark new therapeutic targets for drugs. The Institute of Human Microbiology assisted TGV with Mul-1867’s discovery.

TGV-Laboratories Group of Companies. (http://tgv-labs.com) is a research-based pharmaceutical company headquartered in New York that provides a broad range of innovative products to treat currently untreatable infectious, autoimmune and neurodegenerative diseases. TGV operates under two divisions: the Division of Drug Discovery & Development and the Division of Medical & Industrial Microbiology.

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Quick Takes: the Pharma C-Suite with John Hudak, President: Outsourcing & Strategic Partnerships

In the recent PharmaVoice Feb 2016 PV MagCover FEB16 issue highlighting Outsourcing, PV asked Pharma’s KOL’s to answer some key questions regarding the current state of Outsourcing & Strategic Partnerships.

John Hudak, President & Founder of Criterium Inc Global CRO

John Hudak, President & Founder of Criterium Inc Global CRO

John M. Hudak, President and Founder, Criterium Inc., Global CRO answered these 2 questions for them:

  • What barriers continue to limit CROs and sponsors from becoming true development partners?

Sponsors can have unrealistic expectations of CRO partners. Most partnerships work top-down at both Sponsors and CROs, and are evidenced in timelines and budgets. But top-down management may not always translate into trickle-down commitment. There are some discouraging figures out there about the high percentage of studies that don’t meet their timelines. When timelines and budgets are estimated to satisfy board members or project committees, it’s imperative to include all key factors that affect early planning stages, and be grounded in fiscal reality.

  • What are the key ingredients to a successful outsourcing partnership?

Planning needs transparency and communication, in concert. Sponsors can sometimes have impractical expectations regarding timelines and budgets. And CROs can end up having the same unrealistic expectations of study sites. Everyone wants to meet expectations and win the job – but this sometimes results in unworkable time estimates and budgets. There needs to be more open discussion among stakeholders, Sponsors, CROs and sites regarding the environments in which studies are conducted — and realistic strategies for successful completion.

About John M. Hudak, MBA, President and Founder
John has more than 40 years of experience in the pharmaceutical research and business development arena serving the pharmaceutical and contract clinical services sectors. He has extensive expertise in strategic planning and competitive analysis, market development, promotional planning and tracking, proposal design and custom-services development, international project management and clinical study completion, protocol design and implementation, electronic data capture, and market communications and has worked with drugs, biologics, generics and medical devices.

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Study Shows Many People With Obesity Still Consider Themselves Healthy

New study finds that many people with obesity consider themselves healthy despite having obesity-related comorbidities

fat-shadow-man-1168363 by Michal Zacharzewski FREEPIK

Photo courtesy Michal Zacharzewski via FREEPIK.com

Initial data from Awareness, Care & Treatment In Obesity MaNagement (ACTION), the first nationwide U.S. study to investigate barriers to obesity management, were presented on November 6 at ObesityWeek 2015, the 3rd annual combined congress of the American Society for Metabolic and Bariatric Surgery and The Obesity Society. Notably, results highlight a general lack of understanding of obesity as a disease and its impact on the body, with the majority of people with obesity (75%) indicating that they perceive themselves as “healthy,” although nearly three-quarters had obesity-related comorbidities. 1

“People with obesity often struggle to successfully manage their weight and obtain the help they need to maintain weight loss and improve their health,” said Joseph Nadglowski, president of the Obesity Action Coalition, a non-profit coalition helping individuals affected by obesity. “The findings from the ACTION study indicate that the challenges many people with obesity face may stem from their misperception that obesity is a lifestyle issue that can be overcome simply by eating less and exercising more, instead of a complex disease that requires a comprehensive care approach.”

Other findings from this early qualitative phase of the ACTION study highlight differences in perception of obesity between people with obesity and health care professionals. While people with obesity and health care professionals considered obesity a combination of disease and lifestyle, their primary emphasis differed widely—the majority of people with obesity (65%) considered obesity primarily a lifestyle issue, while the majority of health care professionals (88%) considered obesity a disease. 1 All results were drawn from focus groups and interviews conducted with people with obesity (n=43) and health care professionals (n=24).

“These variances in perception of obesity and its causes may be one reason why patients and clinicians are not engaging in the necessary conversations that lead to solution-based strategies to address weight-related health problems and its long-term management. The aim of ACTION is to gain a better understanding of all the barriers that prevent effective obesity care and to devise successful approaches to overcome modifiable barriers,” said Dr. Nikhil Dhurandhar, president of The Obesity Society and member of the Steering Committee for the ACTION study.

Additional disparities between people with obesity and health care professionals related to perceptions of key barriers to weight management were identified in this initial qualitative phase of the ACTION study. The disparities relate to food habits, social relationships, and limited understanding of how to lose weight. 1

The initial qualitative findings of the ACTION study indicate that multiple barriers prevent effective obesity care; this will be further investigated on a larger scale in the subsequent phase of quantitative research. Currently underway, the quantitative study draws from an online survey conducted with 3,000 people with obesity, 600 health care professionals, and 150 employers. The full results of the ACTION study will be released in 2016.

The ACTION study is conducted in the United States and led by a multidisciplinary Steering Committee consisting of representatives from The Obesity Society (TOS), the Obesity Action Coalition (OAC), Integrated Benefits Institute (IBI)—representing employers, as well as obesity experts in the fields of primary care, endocrinology, psychology and nursing. The study is sponsored by Novo Nordisk.  For more information, visit novonordisk-us.com

About Obesity    Obesity is a disease 2 that requires long-term management. It is associated with many serious health consequences and decreased life expectancy. 3, 4 It is a complex and multifactorial disease that is influenced by genetic, physiological, environmental and psychological factors. 5  The global increase in the prevalence of obesity is a public health issue that has severe cost implications to health care systems. 6,7 In the United States, approximately 35% of adults, or nearly 79 million adults, live with obesity. 8,9 Despite the high prevalence of obesity, many people with obesity lack support in their efforts to lose weight and the disease remains substantially underdiagnosed and underreported. 10

About ACTION    Awareness, Care & Treatment In Obesity MaNagement (ACTION) is a U.S. study investigating the barriers to obesity management by examining the perspectives of three groups: health care professionals, people with obesity and employers. The ultimate objectives of ACTION are to create a better understanding of the barriers that prevent people with obesity from receiving the medical care and support they need to improve health, to generate insights to guide collaborative action to improve care, education and support for people with obesity, and to create a platform for communication, to help change how patients, health care professionals and employers approach obesity care.

References  1 Kaplan L Golden A, O’Neil P, et al. Divergence of patient and clinician perceptions of obesity and weight management. Poster presented at: ObesityWeek 2015; November 2-6, 2015; Los Angeles, CA. 2 American Medical Association. Business of the American Medical Association House of Delegates 2013 Annual Meeting annotated reference committee reports: reference committee D. http://www.ama-assn.org/assets/meeting/2013a/a13-addendum-refcomm-d.pdf. Approved June 8, 2014. Accessed September 8, 2014.  3 Guh DP, Zhang W, Bansback N , et al . The incidence of co-morbidities related to obesity and overweight: a systematic review and meta-analysis. BMC Public Health. 2009;9(88):1-20. 4 Peeters A, Barendregt JJ, Willekens F, et al . Obesity in adulthood and its consequences for life expectancy: a life-table analysis. Ann Intern Med. 2003;138:24-32. 5 Wright SM, Aronne LJ. Causes of obesity. Abdom Imaging. 2012;37(5):730-732. 6 World Health Organization. Fact sheet no. 311: obesity and overweight. http://www.who.int/mediacentre/factsheets/fs311/en/. Updated January 2015. Accessed October 6, 2015. 7 Cawley J, Meyerhoefer C. The medical care costs of obesity: an instrumental variables approach. J Health Economics. 2012;31(1):219-230. 8 Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014;311(8):806-814. 9 Centers for Disease Control and Prevention. Adult obesity facts. http://www.cdc.gov/obesity/data/adult.html. Updated September 21, 2015. Accessed October 26, 2015.  10 Crawford AG, Cote C, Couto J, et al. Prevalence of Obesity, Type II Diabetes Mellitus, Hyperlipidemia, and Hypertension in the United States: Findings from the GE Centricity Electronic Medical Record Database. Popul Health Manag. 2010;13:151–161.

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Clinical Trials Monthly Case Study Analysis: Cost Reductions / Hematology

Each month, we investigate a different Clinical Trial Case Study that posed us with a challenging question – this time it’s a look at an orphan indication in HEMATOLOGY, and significant cost reductions for the sponsor:

We asked ourselves:

Scenario: A Phase IV study was required by the FDA as a condition of approval of an orphan drug. The sponsor was faced with monitoring, managing, and locking data for a 12-month study conducted at 100 sites.

•    Criterium offered an integrated technology-enhanced solution that allowed the sites to register ePRO Patient Diaries Input-Output Diagrampatients and allowed the patients to record their event data directly into our remote systems.
•    Criterium’s solution enabled the client to eliminate most of the scheduled monitoring visits. Criterium’s diligence and centralized system meant that monitors only had to visit sites that had problems.

What If:  If the client had used traditional methods, the cost would have soared for a product that has modest revenue and it would have taken much longer to provide the data to the FDA and the prescribing community.

Results:  Criterium’s centralized real-time data accession utilizing Automated CRFs and Interactive Voice Response (IVR) medical history and patient diary application saved the client $1 million to $1.5 million in clinical monitoring and data management costs. In addition, the data were satisfactory for rapid submission to the FDA for conditional approval, were provided to the medical community to support the indication for which the drug was approved and numerous publications resulted from this fairly large body of data for this orphan indication.

Read more of our successful case studies: http://www.criteriuminc.com/case_studies.php

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