Renowned Breast ncologist Heads to USC
The News Review:
- Renowned Breast ncologist Heads to USC
- Clinical integration’: laudable but challenging
- mniComm Systems Announces Acquisition of EDC Business of …
- West Wireless Health Institute Teams with Corventis for its First …
- pinpointe¢ footlaser¢ Launches Major Multi-Center Clinical Trial …
- Synthes’ relationship with surgeons questioned
Renowned Breast ncologist Heads to USC
USC News
Tripathy is a national authority in breast cancer” Puliafito said. “We are delighted that he is coming to USC as we strengthen our clinical research activities and our patient-focused programs. He was also president and chief executive officer of Physicians’ Education Resource in Dallas a continuing medical education and publishing company specializing in oncology and hematology. As the incoming co-leader of the Women’s Cancer Program Tripathy has identified several goals including developing a nationally recognized women’s cancer service; increasing the number of treatment and clinical trial options for patients; developing a clinical trials and research program that matches the needs of patients and interfaces with the areas of scientific excellence at USC; setting up community outreach programs and forums; and establishing a national and international leadership position in medical peer oncology education. “I believe that USC is responding to a new mission that is an expansion of patient care a bigger commitment to research and a dedication to having the two work side by side” Tripathy said.
Clinical integration’: laudable but challenging
Nature.com (subscription)
While superficially such selectivity seems prudent some deserving avenues of investigation might be abandoned on the basis of cost and difficulty of randomization. Third increasing bureaucracy presents a challenge. Two highly noble causes have demanded that clinical research be overseen: protection of human rights from abuse; and establishment of a formal structure within which efficacy and tolerability of drugs or devices can be interpreted. Since 1962 when the FDA reviewed the evidence for all pharmaceuticals being marketed there have been innumerable layers of rules and regulations added but little has been done to delete rules of little or no benefit. 4 Such bureaucracy has led to skyrocketing costs of drug development the emergence of clinical research organizations and delays in trial design conduct and activation. We are saddled with burdensome and duplicative reviews and documentation. There must be change on a national and international basis.
mniComm Systems Announces Acquisition of EDC Business of …
MarketWatch
com) provides customer-driven Internet solutions to pharmaceutical biotechnology research and medical device organizations that conduct life changing clinical trial research. mniComm’s growing base of satisfied customers is a direct result of the company’s commitment to deliver products and services that ensure ease of use faster study build ease of integration and better performance. mniComm’s client intuitive pricing model allows companies that range from small to mid-size to large scale institutions to safely and efficiently capitalize on their clinical research investments. mniComm Systems Inc. has corporate headquarters in Ft. Lauderdale Florida with offices in Bonn Chicago Germany Tula Russia California New York New Jersey North Carolina Tennessee Massachusetts and Georgia. About eResearchTechnology Inc.
West Wireless Health Institute Teams with Corventis for its First …
PR Newswire (press release)
president and CE of Corventis. “ur technology is designed to deliver focused visibility into the cardiac health status of patients by combining patient-friendly wearable sensors with advanced computational algorithms global wireless capabilities and a comprehensive web-based infrastructure. Corventis will work closely with the Institute’s clinical research and wireless engineering teams to ensure the research devices improve the existing level of care and are safe reliable and cost effective. Don Jones vice president of Health and Life Sciences at Qualcomm and the Institute’s chief wireless officer will lead the integration of wireless technology with the clinical research activity. “This unprecedented combination of clinical research and wireless engineering represents a phenomenal change in the way we will administer and experience health care moving forward” said Jones. “This research program will develop revolutionary new methods to create more efficient and less expensive individualized health care and will enable wireless sensors and remote monitoring technologies like those from Corventis to become much more pervasive.
pinpointe¢ footlaser¢ Launches Major Multi-Center Clinical Trial …
Business Wire (press release)
(Cantab) DABD FAAD FRCPC one of the world’s most respected researchers in nychomycosis and Director of Mediprobe Research a world class dermatology research and clinical trials center where the study will be conducted. Site #2 – Seattle WA. Site #3 is – San Antonio TX. The chief investigator will be Richard Pollak DPM a leading researcher in the field of nychomycosis. The facility Endeavor Clinical Trials PA located in the Medical Center of San Antonio is a privately owned multi-therapeutic dedicated research center set up to conduct Phase II-V trials. Site #4 – Rochester NY.
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Synthes’ relationship with surgeons questioned
Philadelphia Inquirer
Federal law requires that patients involved in research give informed consent which includes making sure the patient understands the risks involved in experimental procedures. It is not clear that patients knew the risks in using Norian XR in these surgeries. "Informed consent is a bedrock principle of clinical research" said Hal Sox editor of the Annals of Internal Medicine a medical journal published in Philadelphia. ne of the surgeons whose patient died told Synthes executives that he had "noticed a cement leak during injection and feels this was the cause of the incident" according to the indictment. The surgeon complained that a Synthes "sales consultant pushed this product on him and was unclear as to its status on the market. "Synthes executives allegedly failed to report the first patient death to the FDA as required by law and left out key details when they reported the two other deaths to hide off-label promotion of Norian XR the indictment said. In November 2004 Synthes told the FDA it was going to take Norian XR off the market.
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