Target Health and Clinical Trials of the Future

 

We have been asked repeatedly how Target Health and the CRO business, in general, are preparing to address clinical trials of the future, acknowledging that trial management will be different.

 

We cannot tell you about other CROs, but at Target Health we currently run a fully paperless clinical trial operation. There are no file cabinets, ring binders and paper copying in clinical operations and throughout the company. And “to put our money where our mouth is,“ we already have one FDA approval, and currently, there is an NDA with 7 studies under review. Each program was run and managed in a paperless manner. We also have 2 ongoing pivotal trials in neurology/psychiatry and several phase 2 programs, with one program using Target e*ICF™. Target e*ICF allows for online informed consent fully integrated with Target e*CRF® with no external devices required. We have met with FDA at a Type C meeting and have shared what we are doing with EMA and Health Canada. There have been 8 flawless FDA pre-approval site inspections as well as an inspection of Target Health in 2015, with no Form FDA 483 issued.

 

The performance metrics are very impressive. We tend to visit sites just 2 times/year and do central risk-based monitoring tied in with Quality by Design (QbD) meetings. Cients are experiencing fewer queries as well as fewer protocol deviations and violations. One large client locked a database 4 months ahead of schedule and sites are able to see twice as many patients in a day. The reason is that once the patient leaves the clinic, there is “nothing to do” except respond to queries. For a study with 40 sites and 900 subjects, only 2% of forms were queried with less than half resulting in a database change and “none of the changes mattered.“

 

We have many online project management reports, as well as general and study-specific risk-based monitoring (RBM) reports. Other features include: 1) SAE management with the ability to generate initial and followup FDA Form 3500A files with eSignatures; 2) IMP management; 3) randomization; 4) batch edit checks, and 5) onsite and central monitoring reports, etc.

 

In terms of analytics, we believe that when appropriate, basic statistical approaches can be set up to look at outliers. However, for clinical trials, advanced analytics may not be overly helpful for a given study, but could be very useful across studies. Part of future planning is to set up an analytics group within Target Health.

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). 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.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

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Wound Care in 2016

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Source: National Heart, Lung, and Blood Institute

 

 

Peripheral Artery Disease

 

According to the Mayo Clinic, peripheral artery disease (PAD) develops when blood vessels slowly narrow and cut off circulation to limbs, especially the 1) ___. According to the Mayo Clinic, PAD has a number of accompanying side effects, including numbness and weakness, skin discoloration, delayed growth of hair and nails, and painful cramping. In its advanced stages, PAD can lead to critical limb ischemia. The nonprofit organization Vascular Cures explained that CLI often leads to ulcers, gangrene, and in some cases, amputation. A 2010 study in the Journal of the American College of Cardiology found that CLI patients have a first-year amputation rate of approximately 30%. That’s an estimated 230,000 amputations in North America and Europe each year.

 

To better manage both PAD and CLI, and prevent wounds, if possible, a group of scientists have come up with an inventive new treatment option. In a study published in the inaugural edition of the Journal of the American College of Cardiology: Basic to Translational Science, a team of bioengineers from the University of California, San Diego unveiled a highly specialized gel that can improve blood flow and help rebuild muscular structures. The gel was originally derived from a pig’s cardiac muscle tissue, which was stripped of cells until all that was left was an extracellular 2) ___ (ECM). A 2010 study in the Journal of Cell Science noted that the ECM is responsible for tissue regeneration and regrowth. The San Diego team found that the gel worked wonders with PAD in the rat model. From there, the team modified the gel, taking new samples from a pig’s skeletal muscle, and used this new formula on laboratory rats for seven weeks. By the end of the trial, the researchers found that the rats’ blood vessels and muscle fibers were similar in size and structure to those of otherwise health specimens. There is still some research being conducted into how the gel prevents PAD and CLI, but scientists believe the gel creates a fibrous scaffold which draws muscle stem cells toward it. From there, those cells help minimize the inflammatory response, which in turn aids muscle development. In an accompanying press release, lead author Karen Christman said this was the first time anyone has treated PAD or CLI with an injectable gel. In the coming months, Christman and the rest of the team will fine-tune safety protocols and examine other disease models. They hope to have the 3) ___ ready for clinical use by 2018.

 

Wound Care Products

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Photo Source: By Keithf2008 (Wikimedia Commons) / Kei_Jo (Wikipedia) – Transferred from en.wikipedia to Commons by Fastilysock using CommonsHelper., Public Domain, https://commons.wikimedia.org/w/index.php?curid=10021782

 

 

Thanks to a bevy of recent technological advancements, wound dressings, ointments and other products can be made from many non-traditional ingredients and components. For instance, collagen dressings are made from pig and horse4) ___, while alginate is derived from seaweed. Yet research continues upward and onward, and with it comes a slew of exciting new innovations. Here are just a few recent projects that could improve the wound care industry in the years to come:

 

The Sun Daily reported that researchers from the Universiti Sains Malaysia have created a brand new healing cream derived entirely from the Haruan fish. The cream, which is called Mu-Derm, works via angiogenesis, or the creation of new blood vessels. But why use haruan, a fish native to Southeast Asia best known as a delicacy, in a wound care cream? As head researcher Dr. Amin Shah Abdul Majid Malik explained to Sun Daily, haruan contains a series of unique proteins geared toward 5) ___, and can heal wounds in half the normal time of other creams. A 2014 study published in the online journal Biologia noted that haruan has an especially powerful immune system, capable of fighting off infections that are killing other fish in the same regions. When it comes to market, Mu-Derm is expected to be used for patients with sensitive skin and as an anti-inflammatory agent.

 

According to Statista, the world produces an average of 402.6 metric tons of paper each year. Needless to say the entire planet produces inevitable paper waste, and there is only so much of it that can be recycled. Phys.org reported, a team of scientists at the National University of Singapore have found a novel approach to dealing with paper waste: turn it into multi-purpose, ultra-light super material. The new material involves turning paper waste into green cellulose aerogels, which according to the researchers, is the lightest material known to man. Not only that, but aerogels are cost-effective and much better for the environment. While this new aerogel can clean up oil spills and serve as heat insulation, it can also be compressed to serve as a plug for most wounds, especially those that are life-threatening. In several tests, sponges made from the aerogel were able to stop 6) ___ in under 20 seconds, which could have huge implications for the emergency medicine sector.

 

 

Treating Leg Ulcers

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Venous ulcer on the back of the right leg. Source: Wikipedia

 

For patients coping with vein disease, diabetes, osteoarthritis, and other diseases that compromise the circulatory system, leg ulcers represent a potentially serious risk that could lead to health complications. According to American Family Physician, venous 7) ___ are the most common type of lower extremity ulcerations and affect 1% of adults living in the U.S. Venous ulcers are often chronic wounds, known for recurring and persisting for weeks or even years without proper treatment. The best place to start the wound healing process for chronic leg ulcers is with a doctor’s prescription for advanced wound care products. Circulatory issues, vein disease, diabetes, obesity, and hypertension are a few of the health conditions conducive to the development of leg ulcers, as well as bacterial skin infections that resist healing. Signs of a possible leg ulcer include swelling, pain, yellowish-green seepage, loss of skin pigmentation around the ulcer, and hyperkeratosis (abnormal skin thickness). Unless treated with the right 8) ___wound care products, leg ulcers may enlarge and cause bone infections, cellulitis, and even necrotizing fasciitis. It is vital to properly apply the appropriate type of dressing or other wound care product when treating slow-healing wounds like leg ulcers. Initially, your physician will debride skin ulcers to decrease your risk of infection and promote wound healing. Following debridement, leg ulcers should be flushed with a non-cytotoxic or sterile saline cleanser before applying a dressing or compression bandage.

 

Compression garments, or dressings that put pressure on leg ulcers, encourage blood 9) ___ and prevent swelling and ulceration. Multi-component dressing systems, such as using a combination of compression stockings and wound dressings, seem to work better when one component is an elastic-type bandage. An optimized compression bandage system, as may be suggested by a physician for treating leg ulcers and venous insufficiencies in the lower extremities, is anatomically conformable, meaning it permits full movement and functionality of your leg. This is ideal, as compression garments need to feel comfortable while resting or doing physical activity.

 

Leg ulcers often become chronic due to bacterial infections that prove difficult to heal. Research investigating the efficacy of silver-based wound dressings for fighting bacterial infections found that silver molecules produced by nanotechnology promote healing of chronic wounds. Silver-based dressings used in wound care treatment utilize fibers infused with silver in the part of the bandage that touches the wound surface, thereby directly defending the wound site against bacteria. Research results regarding the use of active and interactive dressings indicate that active (or biological) dressings innervate growth factors vital to stimulating wound closure much more than passive dressings, which simply cover the wound and absorb drainage. Additionally, cellular and tissue-based wound care products provide a favorably moist environment necessary for successful leg ulcer management. Topical wound care products often recommended for leg ulcers include foam dressings, antimicrobial dressings, and alginate dressings. Foam dressings promote a moist wound environment and easily conform to different sizes and shapes, making them a great option for leg ulcers. Alginates are capable of absorbing large amounts of wound drainage and promote new skin growth. Gels formed by alginate wound care products further prevent wound dehydration while supporting debridement necessary for healing chronic leg ulcers. Because of their versatility, both foam and alginate dressings can be used in conjunction with silver-based dressings to fight 10) ___.

 

ANSWERS: 1) legs; 2) matrix; 3) gel; 4) tissue; 5) angiogenesis; 6) bleeding; 7) ulcers; 8) wound; 9) circulation; 10) infection

 

Online Wound Electronic Medical Record (OWEMR)

 

To help monitor and guide the treatment of diabetic foot ulcers and other chronic wounds, Dr. Harold Brem’s team at Winthrop University has developed and pioneered the use of a comprehensive Online Wound Electronic Medical Record (OWEMR) that incorporates up to 137 medical variables for each patient. The OWEMR’s important features include a highly effective one-page summary of all key factors in each patient’s condition, as well as a system for automatically alerting the patient’s medical team whenever the record indicates the emergence of a potential problem.

 

The OWEMR has proven to be an invaluable tool for assessing the progress of individual patients, and for alerting all relevant caregivers when a diabetic foot ulcer is on the verge of developing a dangerous complication or when its healing process has plateaued, signaling the need for an additional surgical debridement and reapplication of regenerative therapies. It also presents a real-time, single-screen summary of the information most relevant to each patient’s wound healing, including:

 

1. A digital photograph of the wound that is updated on a daily basis (this photographic approach to wound documentation was developed by our team).

2. A real-time graph of the wound healing rate (length, width, depth and area over time).

3. A summary of the patient’s medical history, including hematology and chemistry laboratory data, radiology and pathology reports, and all wound treatments and medication.

 

Finally, the OWEMR’s built-in treatment protocols can also be used to help disseminate Winthrop’s state-of-the-art diabetic foot ulcer therapeutic program to other wound-healing centers in the U.S. and elsewhere. Trials are currently underway to evaluate the OWEMR’s effectiveness as a clinical decision support tool.

 

Target Health is pleased that our software programming team built the OWEMR for this most important program.

History of Wound Care

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Source: Wikipedia Commons

 

The history of wound care spans from prehistory to modern medicine. Wounds naturally heal by themselves, but hunter-gatherers would have noticed several factors and certain herbal remedies would speed up or assist the process, especially if it was grievous. In ancient history, this was followed by the realization of the necessity of hygiene and the halting of bleeding, where wound dressing techniques and surgery developed. Eventually, realization of the germ theory of disease was a major step in improving wound care as wound infection is a major deterrent to optimal wound healing.

 

Over time, different civilizations began to create their own herbal medicinal treatments for wounds depending on the trees, shrubs, or any other type of plants located in their environment. These herbal treatments became the oldest form of wound therapy. It is logically assumed that this may not have been a very safe way of treating humans with wounds due to overdosing or choosing the wrong plants to cure a person until the right one was found. Nevertheless, most of the ancient people who were given the duty of healers through the usage of herbs were well accustomed with which plants from their local flora could be used to help the injured. This knowledge was learned and passed down after healers repeatedly used as herbal remedy for a specific wound and its curing powers were discovered by the fact it promoted healing.

 

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A glass container containing tubocurarine chloride. Tubocurarine was used in ancient times as a poison, but was used in the 20th century as a muscle relaxant. Source: Wikipedia Commons

 

 

Numerous ancient herbal remedies and poisons now serve as models for modern medicine. For example, curare, which was an ancient South American arrow poison, was used in the 20th century as the muscle relaxant tubocurarine. Tribesmen conducted various observations on the effects of different plant parts, meaning roots, leaves, etc., on specific wounds. They also observed what seasons, time of day, or moon phase would result in a most active plant. The former however resulted in a minimal influence in modern medicine as compared to plants parts or seasons of growth. As tribal healers developed into doctors, it spurred on a primitive pharmaceutical industry that included traders who would travel oversees bringing herbs that would cure specific wounds. Soon, like most industries, patients began to skip the doctors altogether and purchased the herbs directly from the traders who were also aware of the effects and quantities that should be taken while also informing their “patients“ of them. These merchants that supplied people with herbs were known as rhizotomiki, or gatherers of roots, in Ancient Greece. The earliest known list of herbs and remedies was probably written for these herbal merchants. The earliest known to men is the Rhizotomika of Diocles of Carustius, a student of Greek philosopher Aristotle. This book includes the author’s observation of the effects of the herbal medicine on specific parts of the human body. This then became the beginning of scientific research on herbal remedies on humans, which has been modified and significantly changed from modern wound remedies.

 

The clinical history of the treatment of acute and chronic wounds can also trace its origins to ancient Egypt. The Ebers Papyrus, circa 1500 BCE, details the use of lint, animal grease, and honey as topical treatments for wounds. The lint provided its natural absorbency, the animal grease provided a barrier to environmental pathogens, and the honey served as an antibiotic agent. The Brugsch Papyrus, circa 1200 BCE, stated that the Egyptians believed that making sure a person’s wound stayed closed would help their spirit not be invaded by evil spirits. The Greeks also acknowledged the importance of wound closure, and were the first to differentiate between acute and chronic wounds, calling them “fresh“ and “non-healing“, respectively. Galen of Pergamum, a Greek surgeon who served Roman gladiators circa 120-201 CE, made many contributions to the field of wound care. The most important was the acknowledgment of the importance of maintaining wound-site moisture to ensure successful closure of the wound.

 

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This is the root of the Turmeric plant that had been sliced and boiled. Turmeric was used in the ancient times to promote wound healing. Source: Wikipedia Commons

 

 

Turmeric is a well-known spice that is utilized in India for use in cooking and medical treatments. The implementation of Turmeric in medical administration can typically be explained by the factor that Curcumin is a component that is contained within Turmeric. Curcumin is an antioxidant that assists in reducing the pain and effect that is caused by inflammation, and furthermore, is found to accelerate the process of wound healing. In the historical times around some areas of India, the people who would practice this treatment would begin by applying a healthy amount of Turmeric paste onto the wounded area, followed by a wrapping of clothes around the area; in many tribal locations this treatment is still performed.

 

Anemia is a disease that is caused be a deficiency of iron, where an individual doesn’t contain enough red-blood cells to transport sufficient oxygen to the exterior body organs, otherwise known as tissues. Thus, with the surplus of iron in additives such as, tablets, pills, and vegetables, the effects of such a disease can be hindered or even prevented. Furthermore, in relation to wounds, it is often recommended by many doctors and surgeons that patients are encouraged to intake food and medicine that are high in iron to accelerate wound healing.

 

Honey was utilized for its antibacterial properties that helped heal infected wounds. Moreover, honey was used as a topical ointment. Other than glucose, which is another name for sugar, honey also contains a variety of trace amounts of many different vitamins and amino acids, which are also known as proteins. The method used with honey, in regards to assisting medical treatments, mainly wounds, is by pouring and plastering a wholesome amount of it on the area of the wound. This technique will support in the reduction of pain, inflammation, and swelling. Furthermore, the antibacterial features that honey contains also constrain the wound from infection and growth.

 

Various types of alcohol were also used in ancient medical practices. One of the first uses was by the Sumerians who used beer as an antiseptic along with the dressing of wounds, using up to 19 different types of beer. Other Ancient Arabic cultures, including the Sumerians and Akkadians used wine with sesame infusions, which were “purified and pulverized“ before application along with the many beers. Another peoples to take advantage of the cleansing properties of alcohol were the Greeks. They used wine along with boiled water and vinegar to cleanse wounds. The Greeks, specifically Hippocrates (430-377 BCE), were also the first to establish the four cardinal signs of inflammation: redness, swelling, heat and pain. Alcohol is still in use today as a wound cleanser largely as rubbing alcohol. However the side effects can be skin cell death resulting in inflammation and itchiness at the site of application.

 

There were limited advances that continued throughout the Middle Ages and the Renaissance, but the most profound advances, both technological and clinical, came with the development of microbiology and cellular pathology in the 19th century.

 

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This is a portrait of Joseph Lister who was the first doctor to begin to sterilize his surgical gauze. Source: Wikipedia Commons

 

 

The first advances in wound care in this era began with the work of Ignaz Philipp Semmelweis, a Hungarian obstetrician who discovered how hand washing and cleanliness in general in medical procedures prevents maternal deaths. Semmelweis’s work was furthered by an English surgeon, Joseph Lister, who in 1860s began treating his surgical gauze with carbolic acid, known today as phenol, and subsequently dropped his surgical team’s mortality rate by 45%. Building on the success of Lister’s pretreated surgical gauze, Robert Wood Johnson I, co-founder of Johnson & Johnson, began in the 1890s producing gauze and wound dressings sterilized with dry heat, steam, and pressure. These innovations in wound-site dressings marked the first major steps forward in the field since the advances of the Egyptians and Greeks centuries earlier. In 1886, Ernst von Bergmann introduced heat sterilization of surgical instruments, which marked the beginning of aseptic surgery and significantly reduced the frequency of infections. Conrad Brunner did extensive research into wound management and experimentation with wound disinfection methods, publishing his comprehensive Erfahrungen und Studien uber Wundinfektion und Wundbehandlung in 1898. That same year, Paul Leopold Friedrich introduced wound excision and experimentally showed that excision of open wounds substantially reduced the risk of infection. The next advances would arise from the development of polymer synthetics for wound dressings and the “rediscovery“ of moist wound-site care protocols in the mid 20th century.

 

During WWI, chemist Henry Drysdale Dakin was consulted and invented Dakin’s Solution, sodium hypochlorate and boric acid, to wash out the traumatic wounds of British soldiers fighting in France. The advent in the 1950s of fibrous synthetics such as nylon, polyethylene, polypropylene, and polyvinyls provided new materials from which researchers and doctors in the field of wound care could explore better protecting of healing wounds and even accelerating the natural wound healing process. In the 1960s, research and articles by George Winter and Howard Maibach reported on the superior efficacy of moist wound dressings. The adoption of moist wound dressing technique as recommended best wound dressing practice reflected a large advance in approach producing markedly superior clinical outcomes. This dawn of modern wound care treatment initiated a process of improvement in the clinician’s ability to bolster wound-site re-epithelialization and healing. The focus on evidence-based best practices and research continues.

 

In the 1990s, improvements in composite and hybrid polymers expanded the range of materials available for wound dressing. Grafting and biotechnology have produced usable and useful protective covering of actual human skin generated through cloning procedures. These improvements, coupled with the developments in tissue engineering, have given rise to a number of new classes of wound dressings. One of these, “living skin equivalents, “ is often cited as a misnomer because they lack key components of whole living skin. “Living skin equivalents“ may have the potential to serve as cellular platforms for the release of growth factors essential for proper wound healing. Many biologics, skin substitutes, bio-membranes and scaffolds have been developed to facilitate wound healing through various mechanisms. Other recent developments has been the renewed focus on the prominent patient concern of pain. Burn patients and others affected by severe wounds often report pain as the dominant negative impact of the wounds on their lives. Clinical management of the pain associated with chronic wounds has been an emergency wound treatment priority and is now viewed as an integral part of treatment.

 

In modern-day 21st century, medicine has evolved to involve past treatments, such as leech therapy, as well as advancing wound prevention and the treatment. A large part of wound care is wound treatment. This involves promoting healing, preventing infections, and getting rid of an already existent infection. Deciding on a treatment, depends on the type of wound that a person has sustained. Varying from infections, to burns, wound care is a priority in saving the limb, extremity, or life of a person. In a hospital or medical care setting, more severe wounds like diabetic ulcers, decubitus ulcers, and burns, require sterile, or clean (depending on the severity of the wound) dressings and wound care. The types of wound dressing include: dry dressings, wet-to-dry dressings, chemical-impregnated dressings, foam dressings, alginate dressings, hydrofiber dressings, transparent film dressings, hydrogel dressings, and hydrocolloid dressings. All of the listed dressing types require different materials to complete the dressing.

 

Dry Dressings: These dressings are typically composed of a gauze material and used for wounds with a small amount of drainage. These dressings are good for keeping the wound covered after cleaning, and to promote healing, as well as taking out small amounts of infections.

Wet-to-Dry Dressings: Although some medical facilities are stepping away from these types of dressings, they are used mostly for post-surgical wound care, as well as debridement of wounds. These dressings take out necrotic areas, as well as infections. In this type of wound dressing, gauze is soaked in saline, placed lightly inside of the wound, and covered with a dry dressing. Once the gauze dries, it can be removed. It dries onto the infection or necrotic areas to remove them. These dressings are being replaced by Wound-Vacs, which are attached to a dressing directly onto the wound, and lightly, but continuously, pulls and sucks exudate and fluids from the wound.

Chemical-Impregnated Dressings: These are provided by manufacturers and they contain chemicals and agents that promote the healing process. Some of these dressings come in sheets and require secondary dressings.

Foam Dressings: Dressings that require additional padding utilize foam pads to help absorb and provide a moist healing environment. They also act as a shield to the wound and prevent any damage from friction or pressure. They can be tricky when applying and removing due to the surrounding skin.

Alginate Dressings: These dressings are composed of calcium, sodium salts and also provide a moist environment for the healing process. They are better used with a larger wound such as ulcers or donor sites.

Hydro-fiber Dressings: These dressings are similar to alginate dressings when it comes to absorbing characteristics, but they do not affect hemostasis. They are composed in sheets which contain polymer carboxymethylcellulose and can be cut according to wound size and severity. However, when using these dressings, a secondary dressing is almost always required.

Transparent Film Dressings: This specific type of dressing is more like a plastic covering for the wound. It allows oxygen to reach it and help heal but does not absorb any fluids. With this being said, transparent film dressings are more used towards dry wounds.

Hydrogel Dressings: This type of dressing is more directed towards infected areas and those in need of a moist environment to heal properly. It helps promote the body’s own natural functions of removing necrotic tissue. It is advised not to be used on dry wounds.

Hydrocolloid Dressings: Unlike transparent film dressings, hydrocolloid dressings do not allow oxygen to reach the wound. It is a wet-to-dry technique but is not recommended for infected areas. This type of dressing can last up to 7 days with a close eye and must be removed with care.

 

Believe it or not, yes, medical leeches were cleared as a medical device in 2004 after being an indispensable tool in the 19th century. This unique use of creatures is utilized in many surgeries today. Leeches have the ability to assist with compromised tissue with the components of their saliva. Their saliva contains a local anesthetic, thrombin inhibitor, antibiotic properties and a histamine-like vasodilator. These capabilities help in surgeries such as transplants, skin grafts, and even reconstructive surgeries. The leeches help localize the wound and help produce blood flow. This is helpful in operations where blood clots occur and they help dilate the blood vessels.

 

Medical maggots were first utilized by military medical aids during World War 2. They worked as biomedical debriding agents by ingesting bacteria and break them down within their intestines. Maggots give off an enzyme that disinfects wounds and promotes healing and this is why they became the first organism in the United States that were used as a medical device in January 2004.

PREVAIL Treatment Trial Opens in Liberia for Men with Persistent Ebola Viral RNA in Semen

 

Liberia was one of the hardest hit countries during the Ebola epidemic of 2014-15. On June 9, the World Health Organization declared the end of the most recent outbreak in Liberia and the country entered a 90-day period of heightened surveillance to ensure that any new cases are quickly identified and contained. It is known that traces of Ebola virus can sometimes remain in a recovered person’s body and can initiate a new bout of illness in the survivor or be passed onto others, which could start a new chain of infection in the community.

 

The Partnership for Research on Ebola Virus in Liberia (PREVAIL), a U.S.-Liberia joint Clinical Research Partnership, announced the opening of PREVAIL IV, a treatment trial for men who have survived Ebola virus disease (EVD) but continue to have evidence of Ebola virus genetic material, RNA, in their semen. “The goal of the PREVAIL IV trial is to see if the experimental drug can eliminate the traces of Ebola virus from semen in men who have survived Ebola infection. It is anticipated that this would also decrease the risk of passing the virus to their partners. If so, the drug would be another weapon in our arsenal against Ebola virus disease. The trial is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, in partnership with the Ministry of Health of Liberia and the pharmaceutical company Gilead Sciences.

 

The six-month study will enroll 60 to 120 EVD survivors whose semen has evidence of Ebola virus RNA prior to their enrollment. Participants in the double-blind trial will receive either investigational drug GS-5734, manufactured by Gilead Sciences, Inc., or a placebo. Upon enrollment, study volunteers will receive the study drug (or placebo) once a day for five days and will provide multiple blood and semen samples during this period. All volunteers must have previously enrolled in the PREVAIL III Ebola Natural History study for survivors and their household and contacts. Prior to enrollment, volunteers will be tested for normal kidney and liver function. Volunteers will be seen at the clinic 10 times in the first month and then once a month for the remaining five months. Volunteers will provide blood and semen samples throughout the trial period. Investigators will test the semen samples to see if Ebola viral RNA can continue to be detected. All volunteers will be counseled to use condoms during the course of the trial. GS-5734 has previously been tested for safety in healthy men and women in the United States. In that study, no serious side effects of the experimental drug were detected, but some volunteers experienced a rise and then a fall in liver enzyme levels. This information has been incorporated into the new trial by the study investigators, who will be monitoring volunteers for kidney and liver function during the trial. In non-human primates infected experimentally with a lethal dose of Ebola virus, GS-5734 has been shown to reduce viremia and to improve survival. Additional information about PREVAIL IV is available at ClinicalTrials.gov.

 

Participants for the Prevail IV study will be recruited from the PREVAIL III study of Ebola survivors and their close contacts which opened in June 2015. Prevail III aims to better understand the long-term consequences of Ebola virus disease, Ebola virus persistence and transmission risk to close contacts, and includes components that assess mental health, eye health and other issues in survivors.

 

NIH Launches Largest-Ever Study of Breast Cancer Genetics in Black Women

 

Survival rates for women with breast cancer have been steadily improving over the past several decades. However, these improvements have not been shared equally; black women are more likely to die of their disease. Perhaps of most concern is that black women are more likely than white women to be diagnosed with aggressive subtypes of breast cancer. The rate of triple-negative breast cancer, an aggressive subtype, is twice as high in black women as compared to white women. The exact reasons for these persistent disparities are unclear, although studies suggest that they are the result of a complex interplay of genetic, environmental, and societal factors, including access to health care.

 

The largest study ever to investigate how genetic and biological factors contribute to breast cancer risk among black women launched on 6 July 2016. This collaborative research project, funded by the National Cancer Institute (NCI), will identify genetic factors that may underlie breast cancer disparities.

 

The Breast Cancer Genetic Study in African-Ancestry Populations initiative does not involve new patient enrollment but builds on years of research cooperation among investigators who are part of the African-American Breast Cancer Consortium, the African-American Breast Cancer Epidemiology and Risk (AMBER) Consortium, and the NCI Cohort Consortium. These investigators, who come from many different institutions, will share biospecimens, data, and resources from 18 previous studies, resulting in a study population of 20,000 black women with breast cancer.

 

As part of the study, the genomes of 20,000 black women with breast cancer will be compared with those of 20,000 black women who do not have breast cancer. The genomes will also be compared to those of white women who have breast cancer. The project will investigate inherited genetic variations that are associated with breast cancer risk in black women compared to white women. In addition, the study will examine gene expression in breast cancer tumor samples to investigate the genetic pathways that are involved in tumor development. According to the NIH, this grant, in combination with previous investments, should help advance the understanding of the social and biological causes that lead to disparities in cancer among underserved populations. In addition, a better understanding of the genetic contributions to differences in breast cancer diagnoses and outcomes among African-Americans may lead to better treatments and better approaches to cancer prevention.

 

Draft FDA Guidances Issued to Advance the Precision Medicine Initiative on Next Generation Sequencing-based Tests

 

The powerful new technology, known as next generation sequencing (NGS), can scan a person’s DNA to detect genomic variations that may determine whether a person has or is at risk of disease or may help to inform treatment decisions. While current regulatory approaches are appropriate for conventional diagnostics that measure a limited number of substances associated with a disease or condition, such as blood glucose or cholesterol levels, the new sequencing technologies can examine millions of DNA variants at a time, and thus require a flexible approach to oversight that is adapted to the novel nature of these tests.

 

FDA has recognized that the field of genetic and genomic testing is dynamic, and that there is a need to encourage innovation while at the same time assuring that NGS-based tests provide accurate and useful results. As a result, in support of the President’s Precision Medicine Initiative, the FDA has now issued two draft guidances that, when finalized, will provide a flexible and streamlined approach to the oversight of tests that detect medically important differences in a person’s genomic makeup.

 

The first draft guidance, titled “Use of Standards in FDA’s Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases” provides recommendations for designing, developing and validating NGS-based tests for rare hereditary diseases, and addresses the potential for using FDA-recognized standards to demonstrate analytical validity, which is how well a test predicts the presence or absence of a particular genomic change.

 

The second draft guidance, titled “Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics” describes an approach wherein test developers may rely on clinical evidence from FDA-recognized public genome databases to support clinical claims for their tests and provide assurance of accurate clinical interpretation of genomic test results – an easier path for marketing clearance or approval.

 

This adaptive approach to regulating NGS-based tests is part of the FDA’s engagement in the Precision Medicine Initiative (PMI). The PMI, launched by the White House in early 2015, is an innovative approach to developing a new kind of health care that takes into account individual differences in people’s genes, environments and lifestyles. The FDA’s role in the PMI is foundational: to create regulatory processes that encourage advances in genomic testing while assuring that NGS-based tests are safe and effective. The FDA has been working with experts in the genomics community to conceptualize this flexible approach that strikes the important balance between safeguarding public health and promoting innovation.

 

Strawberry Heaven

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This lovely dessert has multi-layers of flavor. There are the strawberry liqueur soaked fresh strawberries; the subtle marzipan and the soft crunch of the strawberries themselves. At the bottom of this dish, are crumbs of almond biscotti; however, you can put a tiny piece of pound cake, or anything you have around that add a little surprise, and enhances the already delicious ingredients. Cool whip tops this dessert, but go ahead and add whipped cream, if you prefer. This is the perfect light and lovely summer dessert! I experimented with this recipe several times, until I got it just right.  So, be sure to read the directions carefully. Enjoy! ©Joyce Hays, Target Health Inc.

 

 

Ingredients

 

2 pints of sweet fresh strawberries, they’re in season now

1/2 can marzipan

1/2 to 1 cup strawberry liqueur

1 pint plain Greek yogurt (FAGE)

1 container Tofutti

1 box sugar free strawberry jello (make it & set aside)

Cool whip for garnish

Fresh mint for garnish

 

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Fresh ingredients and easy to make. ©Joyce Hays, Target Health Inc.

 

 

Directions

 

Make the jello, with only one cup of boiling water. Don’t add that second cup of cold water. Then set aside to cool.

 

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Here’s the jello, set aside to cool and waiting to be added later. ©Joyce Hays, Target Health Inc.

 

 

Clean & wash strawberries, then cut into 1/4-inch-thick pieces.

In a bowl, add the strawberry liqueur. Next add the chopped strawberries, stir and let them soak for 1 hour.

Stir the strawberries once in a while to distribute the liqueur well.

 

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Here are the cut up fresh strawberries with the strawberry liqueur added, soaking for 1 hour. Notice the almond biscotti crumbs in bottom of dessert dishes. ©Joyce Hays, Target Health Inc.

 

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Here is the luscious strawberry liqueur I used to soak the strawberries in. I got it online, where I buy most of our wine, Sherry-Lehmann on Park Avenue. ©Joyce Hays, Target Health Inc.

 

 

After 1 hour, place half the soaked strawberries and all the juice in a blender, and puree. Pour puree back in bowl with the other half of the chopped strawberries.

 

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Use a blender or electric beaters. ©Joyce Hays, Target Health Inc.

 

 

In a mixing bowl, add the yogurt, Tofutti, and marzipan and beat together until well combined. Hold back the strawberries, but pour all the strawberry liqueur in with the yogurt/Tofutti mixture. Use a slow speed, or stir by hand, so you combine everything well. If this mixture is too thick, add more strawberry liqueur.

Into the yogurt/ liqueur mixture, use a spatula to scrape all of the solid jello mixture out of the bowl and in with the yogurt/liqueur. Slowly stir it in. Don’t whip it.

Finally, fold the strawberries into the yogurt mixture slowly, and serve or refrigerate for up to two hours and/or overnight. I refrigerated overnight. This can be served from one bowl, or in attractive individual dessert dishes.

Garnish with a few tiny fresh mint leaves and save a few whole strawberries to cut in half. Put half a berry on top of each individual dessert.

 

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Fresh mint leaves for a garnish. ©Joyce Hays, Target Health Inc.

 

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Light and Lovely! All you need is love and a blender. ©Joyce Hays, Target Health Inc.

 

 

All You Need is Love: Beatles

 

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We’re sipping chilled rose wine this weekend, in our special anniversary glasses. ©Joyce Hays, Target Health Inc.

 

 

Imagine: John Lennon; This edition of the newsletter is dedicated to Vanessa.

 

 

From Our Table to Yours !

 

Bon Appetit!