| 8/24/2009 |
Registries Rising: FDA Looking At TNF Inhibitors; AHRQ Updates Standards
The Pink Sheet,
The FDA Amendments Act of 2007 gave the agency many new safety powers and the potential for promotional
restrictions and post-marketing fines have understandably received much industry attention. But FDA also
appears to be drawing upon its beefed-up authority to increase use of a much older, low-tech safety effort: the
patient registry.
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| 8/19/2009 |
Registries for Robust Evidence
JAMA,
Although randomized clinical trials (RCTS) are the bedrock for establishing which interventions are efficacious, there is increasing recognition that they cannot address all needs, especially the need to determine, in a timely manner, the safety and effectiveness of different interventions used in the diverse array of patients and settings that make up a health care system.
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| 5/29/2009 |
FDA Urged to Add Implant Registries, Premarket Data in Sentinel Plan
FDA Week,
FDA is receiving a bevy of recommendations from stakeholders on ways to structure its Sentinel Network initiative, through which FDA will have access to reams of post-market safety data. Orthopedists want to see FDA integrate implant registries into Sentinel and are suggesting methods for FDA to incentivize industry participation.
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| 5/27/2009 |
Product safety takes centre stage
SCRIP,
Numerous initiatives in the US and Europe show that the focus on medical product safety is at its prime.
All healthcare stakeholders are looking towards regulators and thought leaders to determine what the
immediate and residual effects will be.
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| 4/15/2009 |
American Heart Associations Get With the GuidelinesSM (GWTG) Program, developed jointly with Outcome in 2000, recognized in Wall Street Journal
A push to get hospitals to follow prescribed treatment guidelines is showing promising results in improving care for stroke and heart-attack patients and preventing repeat hospitalizations for those with heart failure. Guidelines for treating such patients have been around for years. But surveys have shown that they often aren't followed, especially for women and minorities, and that adherence to the guidelines varies widely around the country.
A program called Get With the Guidelines, launched in 2000 by the American Heart Association, aims to improve outcomes and eliminate disparities in care of heart and stroke patients. About 1,600 U.S. hospitals, or about a third of the total, have so far signed up with the program. Following the release of recent studies showing improved outcomes at hospitals enrolled in the program, institutions are joining at an accelerated pace, program officials say.
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| 4/1/2009 |
Clinical Trials Vs Registries
Applied Clinical Trials,
As health care stakeholders, from regulators to providers to payers, demand more evidence on the safety and effectiveness of drugs and medical devices in real-world use, they are also increasingly asking life science companies to develop patient registries to fulfill this need.
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| 3/24/2009 |
Comparative Effectiveness Research Coming Soon?
Pharmaceutical Executive,
As the political debate on healthcare reform intensifies, comparative effectiveness research (CER) has increasingly been cited as an important tool for reducing costs and improving quality. The American Recovery and Reinvestment Act put CER on the national radar by setting aside $1.1 billion for this research, and President Obama has identified a role for more CER. However, opponents argue that CER will be used as a means to control costs by limiting patient access to new therapies and interfering with the medical judgment of physicians.
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| 3/1/2009 |
Medicare's P4P Program Aims to Improve Care
Managed Healthcare Executive,
For many physicians, their first real experience with pay-for-performance will be through the Center for Medicare and Medicaid Services’ (CMS) Physician Quality Reporting Initiative (PQRI). In 2008, approximately 100,000 providers participated in the program. In 2009, along with the incentive payment (increased to 2%) the participation numbers are expected to grow. Facilitating that growth is the fact that in 2009, physicians may submit data via claims or via the new registry reporting method, greatly increasing the ease of participation.
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| 2/10/2009 |
Quality of Care in Women With Ischemic Stroke in the GWTG Program
Stroke,
Stroke in women is increasingly recognized as an important clinical and public health problem. Because women have a longer life expectancy and have higher stroke mortality in the oldest age groups, more stroke events occur in women than in men. Moreover, this sex difference in the number of stroke events is expected to increase dramatically over the next few decades.
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| 10/17/2008 |
Changes in FDA’s Approach to Risk
Applied Clinical Trials,
Drug safety efforts in the United States underwent a fundamental change in September 2007 with the passage of the Food and Drug Administration Amendments Act (FDAAA).The Act directs the FDA to develop a systematic, scientifically
sound approach to managing the risk–benefit ratio of a drug throughout its lifecycle, with an explicit focus on postapproval safety.
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| 8/1/2008 |
F-D-triple-A steps out to a mixed reception
SCRIP,
The passage of the Food and Drug Administration Amendments Act (FDAAA) in September 2007 was a major milestone for drug safety efforts in the US. While the extensive new legislation gives the US FDA more resources, authority and regulatory tools to ensure drug safety, the most important point of the Act may be its mandate that the FDA shift its safety paradigm.
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| 6/23/2008 |
McClellan Envisions Lifecycle Approach to Drug Surveillance
Bio-IT World.com,
Rising drug development costs and public frustration about major drug recalls highlight the need for an active, post-market drug surveillance system, Mark McClellan told attendees at the recent Post-Approval Summit.
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| 6/16/2008 |
CDER Stresses 'Active' Post-Approval Surveillance
Bio-IT World.com,
Speakers at the recent Post-Approval Summit left no doubt that we are entering a new era of active surveillance of post-approval drugs. Richard Gliklich, chairman of the conference, said a number of forces have recently changed the role of post-approval research from “what had been an afterthought to something far more intrinsic” to the delivery and evaluation of health products
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| 6/2/2008 |
Implications of the FDA’s increased focus on post-approval safety
SCRIP,
The passage of the Food and Drug Administration Amendments Act (FDAAA) in September 2007 represents
a sweeping overhaul of the US system for ensuring the safety of approved drugs. The legislation includes
over 200 provisions dealing with nearly all aspects of the FDA and requires substantial changes in the agency’s
approach to drug safety. Given the wide impact of the legislation, the FDA will need to move forward
carefully to maintain support among multiple stakeholder groups.
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| 5/27/2008 |
CDER’s Woodcock Details Expanded Authority, Sentinel Concept at Post-Approval Summit
CenterWatch Weekly,
Opening the Post-Approval Summit at Harvard, keynote speaker Janet Woodcock,M.D., director of the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), outlined her agency’s expanded authorities in the area of post-approval research oversight brought about by the passage of the FDA Amendments Act (FDAAA) into law at the end of March.
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| 5/27/2008 |
FDA’s Woodcock On FDAAA
Clinpage,
Last week, we quoted Wyeth’s Joseph Camardo on the renewed user fee legislation known as FDAAA. He’s not sure the new post-marketing environment is starkly different from the old one. In thinking of the still-murky FDAAA regulatory landscape, we were reminded of a lyric from The Who: “Meet the new boss, same as the old boss.”
Janet Woodcock, head of the FDA Center for Drug Evaluation and Research (CDER), is in the unusual position of being both the new boss and the old boss. Simultaneously.
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| 5/20/2008 |
Wyeth on FDAAA
Clinpage,
Because of the random sighting of Ira Spector at one conference or another, we’ve always had a soft spot for Wyeth. We don’t know Spector—no need to fret he has been consorting with the news media. But from remarks by Spector and his lieutenants over the years, we’ve gathered Wyeth seems to have anticipated most of the challenges of the eclinical era, and to have aimed for aggressive competitive and operational goals. It’s hard not to admire their efforts.
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| 5/19/2008 |
Observations from the Post-Approval Summit
Applied Clinical Trials,
“We are moving to an age of active surveillance and this will create new issues, but also solutions,” said Richard Gliklich, MD, Harvard Medical School and president and chief executive officer of Outcome Sciences. This past week high-level speakers from industry, government and academia gathered at the Post-Approval Summit held at Harvard Medical School, to discuss various post-approval topics.
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| 3/3/2008 |
When Clinical Trials Aren't Enough
Applied Clinical Trials,
Effectiveness and real-world data underlie the global need for more patient registries and standards.
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| 2/22/2008 |
Clinical trial firms make passage to India
Mass High Tech,
A rapidly growing health-care software company based in Cambridge is expanding its global presence in South Asia with the launch of a joint venture in Mumbai, India.
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| 8/1/2007 |
Designing and Assessing Registries to Evaluate the Safety of Medical Products
ACRP Monitor,
Traditionally, the safety of medical products has been assessed through spontaneous reports of serious adverse events, secondary analyses of administrative data collected for other purposes, and clinical trials and meta-analyses of clinical trials. Recent product recalls and warnings have raised questions about whether these strategies provide enough information about rare clinical events that may occur during conditions of real-world use and whether they are reliable enough to guide decisions on removing products from the market.
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| 5/2/2007 |
Post-Approval Summit: Politician, Serono Speak at Meeting
ClinPage,
"The Post-Approval Summit at Harvard, now in its third year, is the most cerebral conference on our calendar. It is also the meeting most larded with VIP speakers, including a preponderance of physicians who run a) large swaths of international companies or b) big slices of a regulatory bureaucracy in the U.S. or Europe."
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| 5/1/2007 |
Post-Approval Needs Reassessed
Applied Clinical Trials,
Physicians, payers, and patients all want evidence of the real-world results of medical products, therapies, and services. And they want those results for larger and more diverse populations than are typically studied before approval to enable them to judge whether such products and services are safe and effective and how quality of care might be improved.
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| 2/1/2007 |
Post-Approval Research: Safety Net or Power Tool?
BioExecutive,
The method of releasing a new product into the marketplace is a delicate balancing act. A developer naturally wants to release its product ASAP. However, the developer also knows the product has to undergo serious testing before it can safely be made publicly available.
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| 12/18/2006 |
Will CDISC Demo Drive Demand for EDC/EHR Integration?
Bio-IT World, eCliniqua,
Four major pharmaceutical companies and a California systems integration services firm are providing the "brain and brawn" -- as well as the funding – to demonstrate the feasibility of integrating data capture needs of clinical research and disease prevention with electronic health records (EHRs), says Tanyss Mason, director of communications for the Clinical Data Interchange Standards Consortium (CDISC). At present, "it's not unusual for [investigative] sites to have an EHR as well as multiple EDC [electronic data capture] tools, and it's unwieldy."
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| 12/4/2006 |
Sponsors Getting 'Proactive' about Phase IV Studies
Bio-IT World, eCliniqua,
For a multitude of reasons, it’s a good idea for sponsor companies to spend more energy on so-called “Phase IV” post-marketing studies. A maturing drug pipeline is at risk of generic erosion unless new indications are found. Medicare and private health plans are demanding more real-world data as a condition of coverage for specific subpopulations. High-profile recalls have drawn unflattering public attention to blockbuster products.
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| 12/1/2006 |
The Emerging Role of the Patient Registry
Good Clinical Practice Journal,
Patient registries are a valuable post-approval tool, providing evidence of the real-world results of medical products, therapies, and services. While clinical trials give important data about treatment effects in controlled conditions, trial data are often not applicable to the diverse population that may receive the interventions in the post-approval setting. This results in evidence gaps that impede the ability of patients and providers to make informed treatment decisions and of payers to determine what kinds of coverage will be appropriate. Patient registries can close these evidence gaps by offering additional data, to enable decision-makers to judge whether products or procedures are safe and effective.
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| 8/1/2006 |
Registering Results in the Real World
Good Clinical Practice Journal,
A key area of growth in the e-clinical world is the increasing use of patient registries as a tool for monitoring effectiveness and safety, among other measures. We interviewed Dr Richard Gliklich, president and CEO of Outcome Sciences (d/b/a Outcome), to discuss their increasing importance.
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| 6/2/2006 |
Personalized Medicine Meets the Real World?
Pharmaceutical Executive,
The era of personalized medicine was heralded long before its arrival. But not until Herceptin (trastizumab) came onto the market in 1998 to treat breast cancer in HER-2 positive patients did companies understand just how much genomics could alter the health-care landscape.
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