Target Health is pleased to announce that in 2 weeks,Version 1.7 of Target e*CRF® will be released. This version will contain 1) advanced User Management, 2) Batch Edit Checks, 3) Cross-Form Edits Checks programmed in a novel way, 4) Central Randomization, and 5) Target Encoder® for MedDRA and WHO Drug coding. Version 1.8 which will be released end of May, will have full integration with Target e*Pharmacovigilance™ which generates an FDA-approved MedWatch Form 3500A, as well as a CIOMS form, using data directly from the EDC database. Features within Target e*Pharmacovigilance™ allow for full SAE management.

Target e*CRF® has been used in over 160 studies since 1999 with 16 FDA approvals (4 NDA, 1 BLA, 10 PMA and 1 510(k)), as well as approvals in Europe, Canada and other countries. Currently, there is one pending approval in Europe and 2 NDAs will be submitted this year. There have already been 2 products approved this year (1 NDA and 1 PMA).

For more information about Target Health and any of our software tools for paperless clinical trials, please contact Dr. Jules T. Mitchel (212-681-2100 ext 0) or Ms. Joyce Hays. Target Health’s software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website, and if you like the weekly newsletter, ON TARGET, you’ll love the Blog.

For the first time in the US, a stroke patient has been intravenously injected with his own bone marrow stem cells as part of a research trial. On March 25, a patient was transferred to Memorial Hermann – Texas Medical Center after suffering a stroke while working on his farm. He arrived too late to receive 1) ___ plasminogen activator (tPA), the only treatment for ischemic strokes. He became the first patient in a Phase I safety trial, funded with a pilot grant from The National Institutes of Health and support from the Notsew Orm Sands Foundation, which will enroll nine more patients who have suffered a stroke and can be treated with the stem cell procedure within 24 to 72 hours of initial 2) ___. Stroke occurs when blood flow to the brain is interrupted by a blockage or a rupture in an artery, depriving brain tissue of 3) ___. It is the third-leading cause of death behind heart disease and cancer. According to the American Stroke Association, nearly 800,000 Americans suffer a stroke each year – one every 40 seconds. On average, someone dies of stroke every three to four minutes. “It’s still very early in this safety study, but this could be an exciting new therapeutic approach for people who have just suffered a stroke,” said Sean Savitz, M.D., the study’s lead investigator. “Animal studies have shown that when you administer stem cells after 4) ___, the cells enhance the healing. We know that stem cells have some kind of guidance system and migrate to the area of 5) ___. They’re not making new brain cells but they may be enhancing the repair processes and reducing inflammatory damage.” Savitz said that animal studies have shown that the healing effects of stem cells can occur as early as a week but cautioned it is too early to attribute the patient’s improvement to the stem cell treatment. The stem cells were harvested from the bone 6) ___ in the iliac crest of the patient’s leg, then separated and returned to the patient several hours later. Because they are his own stem cells, rejection is not an issue. When the patient arrived at the hospital, he could not speak and had significant weakness on his right side. When he was released after nearly two weeks of hospitalization and rehabilitation, he was able to walk, climb stairs unassisted and speak. His wife said she believes the 7) ___ ___ have helped. The patient has spoken a few times with a single word or a phrase since his return home. The doctors are hopeful that the patient will eventually be able to return to his job as a painter. This study is the critical first step in translating laboratory work with stem cells into benefit for patients. If effective, this treatment could be helpful to a huge segment of stroke patients to reduce their 8) ___. The study is only open to patients who are admitted to the Emergency Center at Memorial Hermann – TMC or through the UT Stroke Team with symptoms of an immediate stroke. Adapted from materials provided by University of Texas Health Science Center at Houston

ANSWERS

1) tissue; 2) symptoms; 3) oxygen; 4) stroke; 5) injury; 6) marrow; 7) stem cells; 8) disability

 

Ancient Egyptians were turning wine into medicine 5,000 years ago, by using a wide range of herbs to give wine medicinal properties. The ancient Egyptians are famous for their medical knowledge and used large numbers of organic products to treat disease and ill-health. Scientists used sensitive biomolecular techniques to analyze residues inside two wine jars from early and late ancient Egyptian history. A jar dating back to 3,150 BCE from the tomb of one of the first pharaohs of Egypt, Scorpion I, was found to have been steeped with herbs. The herbs included balm, coriander, mint and sage, as well as pine tree resin. Another wine amphora from the 4th to 6th centuries CE, found at the Gebel Adda site in southern Egypt, was laced with pine resin and rosemary. Ancient Egyptian records written on papyrus showed that such herbs were widely used as medicines for treating conditions ranging from upset stomachs to herpes. Dr Patrick McGovern, from the University of Pennsylvania, Philadelphia, and colleagues wrote in the journal Proceedings of the National Academy of Sciences: “Ancient wine and other alcoholic beverages are known to be excellent means to dissolve and administer herbal concoctions externally and internally. “Indeed, before modern synthetic medicines became available, alcoholic beverages were the universal palliative.”

Under current federal law, clinical research involving human subjects and FDA-regulated products, such as drugs, biologics or medical devices, must have the review and approval of an “institutional review board“ (IRB). An IRB is a panel of doctors, scientists and non-scientists charged with reviewing the clinical research to protect the rights and welfare of the subjects participating in the study. The FDA has announced that Coast IRB, LLC of Colorado Springs, Colo., has agreed to voluntarily halt some aspects of its clinical trial oversight operations due to serious concerns about the company’s ability to protect human subjects participating in clinical trials. According to the company’s records, these actions may involve approximately 300 active human research studies conducted by some 3,000 clinical investigators. Until further notice, Coast IRB has agreed to stop reviewing new FDA-regulated studies. Also, Coast IRB will direct clinical investigators in on-going FDA-regulated studies approved by Coast IRB to halt new subject enrollment. FDA has issued a Warning Letter to Coast IRB outlining its concerns and FDA will continue to actively monitor the company and take appropriate action as necessary. These restrictions will remain in effect until the FDA is satisfied that Coast IRB has taken necessary corrective actions that bring it into compliance with FDA regulations designed to protect human research subjects. Today’s actions follow a recent undercover operation by the U.S. Government Accountability Office (GAO). The GAO submitted to Coast IRB for review a fictitious research study involving a purportedly FDA-cleared medical device. Although no human subjects were involved, the GAO operation heightened FDA’s concerns about Coast IRB’s ability to protect the rights and welfare of human research subjects. In evaluating the information provided by the GAO investigators, FDA determined that Coast IRB committed several violations of the laws and regulations intended to protect the rights and welfare of human research subjects in clinical trials and that the company failed to perform the robust review needed to approve a study. The FDA’s action is precautionary. Because of the potential risk to enrolled subjects and disruption to the research if on-going studies were abruptly terminated, studies that Coast IRB has already approved will be permitted to continue. However, no new subjects will be permitted to enroll in these studies until there is assurance that the research has undergone adequate review. Coast IRB continues to be obligated to receive and respond to reports of unexpected and serious adverse events as well as to review progress reports submitted by clinical investigators.
 
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