| 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.
|
|
| 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
|
|
| 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.
|
|
| 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.
|
|
| 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.
|
|
| 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.
|
|
| 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.
|
|
| 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.
|
|
| 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.
|
|
|
|
| 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.
|
|
| 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."
|
|
| 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.
|
|
| 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.
|
|
| 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."
|
|
| 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.
|
|
| 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.
|
|
| 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.
|
|
| 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.
|
|