Comparative Effectiveness from Elsevier Business Intelligence

Issues Abound Tracking Efficacy And Effectiveness In Clinical Trials

Thu, 24 May 2012 00:00:00 -0400

A recent JAMA paper assesses the progress of ClinicalTrials.gov, concluding that concerns continue around the use of best methods for generating evidence and the capacity of the clinical trials enterprise to supply the high quality evidence needed to ensure confidence in guidelines. That these issues hold for interventional trials suggests that other strands of clinical research, notably those focused on comparative effectiveness, face similar if not even greater challenges to be able to provide meaningful real-world evidence.

Scant Intersection Between Patient-Centered Outcomes Research And Personalized Medicine’s Needs

Mon, 23 Apr 2012 00:00:00 -0400

On its face, comparative effectiveness research and its new cousin, patient-centered outcomes research, would seem to support, if not enable, personalized medicine. But as currently established in the US, there is little conceptual overlap.

Research In Brief

Mon, 23 Apr 2012 00:00:00 -0400

Comparative effectiveness oversight, 10-year biodegradable stent data and more research news.

Develop CER Strategies, Or Be Left Behind, GSK Exec Says

Mon, 09 Apr 2012 00:00:00 -0400

Execs from GlaxoSmithKline and OptumInsight offer insight on the need for pharma companies to develop strategies that account for the growing role comparative effectiveness research is playing in reforming health care, a role that will continue despite what happens in legal and legislative circles in Washington, D.C.

The State of CER: Some Progress, Cautious Optimism

Tue, 27 Mar 2012 00:00:00 -0400

It isn’t a household name—yet—but the Patient-Centered Outcomes Research Institute has certainly increased its name recognition among health care stakeholders during the last year, especially as it works to meet the federally mandated requirements of the Affordable Care Act. This was just one of the findings by the National Pharmaceutical Council from the second year of surveying key stakeholders about comparative effectiveness research (CER) perceptions and its impact on health care decisions.

Thirteen Principles For Conducting CER, According To United BioSource Exec

Mon, 26 Mar 2012 00:00:00 -0400

During a recent DIA-sponsored conference, United BioSource Corp.’s Bryan Luce previewed a paper that will outline 13 principles that should be taken into account when developing comparative effectiveness research.

Will FDA’s View On Health Economic Claims Change With More Government-Funded Research?

Mon, 27 Feb 2012 00:00:00 -0500

Health care economic information that is disseminated to formulary committees must be based on “competent and reliable scientific evidence.” Yet FDA has traditionally applied a more restrictive “substantial evidence” standard in its enforcement approach, said panelists at a recent conference, who questioned whether the growing government involvement in funding comparative effectiveness research would change this approach.

FDA Product Promotion Regs Shouldn’t Stop Companies From Challenging CER Results, Official Says

Fri, 10 Feb 2012 00:00:00 -0500

FDA’s Bob Temple dismisses the notion that drug companies, even with FDA’s regulation of product promotions, do not have the ability to challenge comparative effectiveness research findings they believe to be false or misleading. He says FDA is in no way trying to “deny them that right.”

DTC Comparative Ads Will Likely Bloom; FDA Studies How To Evaluate New Species

Mon, 12 Dec 2011 00:00:00 -0500

FDA expects to see an increase in direct-to-consumer drug comparison ads after the Agency for Healthcare Research and Quality completes its comparative effectiveness compendium.

Comparative Evidence Needs Earlier Consideration In Drug Development Process – Novartis Exec

Mon, 12 Dec 2011 00:00:00 -0500

As comparative effectiveness research grows in importance, drug manufacturers need to factor it, as well as payer evidence needs, into product development decisions, Novartis Head of Comparative Effectiveness Research and Communications Amy Rudolph says.

Bayer Contraceptives Win Advisory Committee Backing As Panel Rejects Call For Comparative Effectiveness

Thu, 08 Dec 2011 00:00:00 -0500

In a 15-11 vote, FDA advisory panel members split on whether drugs containing progestin drospirenone should be judged on absolute risk, or whether their potentially higher risk than other birth control pills should be offset by benefits beyond those provided by alternatives.

Industry’s CER Efforts Should Follow PCORI Methods, Cmte. Member Yancy Says

Thu, 08 Dec 2011 00:00:00 -0500

Pharma companies’ comparative effectiveness research should be “in sync” with nationalized approach that the Patient-Centered Outcomes Research Institute will bring, Clyde Yancy, member of the new institute’s Methodology Committee, suggests.

Industry’s CER Efforts Should Follow PCORI Methods, Cmte. Member Yancy Says

Tue, 06 Dec 2011 00:00:00 -0500

Concepts For PCORI Research Agenda Stress "Thinking About Patients"

Mon, 28 Nov 2011 00:00:00 -0500

Comparative-effectiveness research projects will focus on outcomes that patients find meaningful, says Harlan Krumholz of the Patient-Centered Outcomes Research Institute. He describes other concepts that will guide development of the institute's research agenda.

HHS Essential Health Benefits Standards Must Reflect Cost Concerns - IoM

Fri, 07 Oct 2011 00:00:00 -0400

Institute of Medicine releases recommendations on the development of EHB, under which comparative effectiveness research would play a key role in future updates to the EHB package.

Xarelto Review Puts FDA’s Comparative Effectiveness Stance To The Test

Mon, 19 Sep 2011 00:00:00 -0400

Pharmaceutical sponsors across therapeutic categories may have breathed a sigh of relief when FDA’s Cardiovascular and Renal Drugs Advisory Committee said that Bayer/Johnson & Johnson’s Xarelto (rivaroxaban) need not show it is “as effective” as Boehringer Ingelheim GmbH’s anticoagulant Pradaxa (dabigatran) in atrial fibrillation patients.

China's Health Card Program Offers Potential For Massive Data Mining

Tue, 30 Aug 2011 00:00:00 -0400

Fifty percent of the country's residents are slated to receive electronic medical cards by year's end, establishing a system that could vastly improve personalized care, comparative effectiveness research and adverse event monitoring.

Canada Outlines “Patient-Oriented Research” Strategy

Mon, 29 Aug 2011 00:00:00 -0400

Canada is developing a comparative effectiveness research strategy that, like the Patient-Centered Outcomes Research Institute in the U.S., is targeting a patient-focused approach that aims to ensure that patients get the right treatments at the right times.

Sensor-Augmented Insulin Delivery Adds Benefit – AHRQ Analysis

Mon, 22 Aug 2011 00:00:00 -0400

Insulin infusion therapy augmented with continuous glucose monitoring for type-1 diabetics received a measure of support in a draft government comparative effectiveness analysis, but more research is needed, the Aug. 15 Agency for Healthcare Research and Quality report concludes.

AHRQ Sleep Apnea Review: CPAP Tops, Mouthpiece An Option

Mon, 15 Aug 2011 00:00:00 -0400

Available evidence points to continuous positive airway pressure therapy as the most effective treatment for obstructive sleep apnea, but patient compliance to CPAP remains poor, so alternatives are necessary, according to a Aug. 8 comparative effectiveness review contracted by the Agency for Healthcare Research and Quality.

AHRQ Sleep Apnea Review: CPAP Tops, Mouthpiece An Option

Mon, 15 Aug 2011 00:00:00 -0400

CER Could Lead To $10 Bil. Per Year Drop In R&D – Think Tank Analysis

Mon, 08 Aug 2011 00:00:00 -0400

Investments in drug and medical device research and development will decrease as comparative effectiveness research conducted under the Patient-Centered Outcomes Research Institute begins to gain traction, Benjamin Zycher, senior fellow at Pacific Research Institute, predicts.

No Comparison: Viibryd’s Path Of Least Resistance Through FDA Could Mean Rocky Marketing

Mon, 01 Aug 2011 00:00:00 -0400

FDA’s statutory neutrality on comparative effectiveness in drug approval decisions both helped and held back Viibryd (vilazodone), now owned by Forest Laboratories. Because approval requires only that a candidate proves superiority to placebo, not to any existing treatments, the antidepressant entered a highly competitive, crowded market with statistically significant but commercially unremarkable efficacy.

Employers Eye CER To Improve Employee Health, Lower Costs – NPC Survey

Mon, 11 Jul 2011 00:00:00 -0400

Large employers and those companies that self-insure are expecting that comparative effectiveness research will lead to better employee health and help companies achieve their cost-management goals, according to the results of a survey released June 21 by the National Pharmaceutical Council.

NPC Seeking Proposals For CER Research On Health Care Decision Making

Mon, 11 Jul 2011 00:00:00 -0400

The National Pharmaceutical Council has issued a request for proposals seeking new research that is focused on the current comparative effectiveness research and health care decision-making environment

CER Credibility Lies In Methodology For Studies, Physician Tells BIO

Mon, 11 Jul 2011 00:00:00 -0400

The credibility of comparative effectiveness research ultimately will be judged based on the methodology used to conduct the research, David Charles, associate professor and vice-chairman of neurology at Vanderbilt University Medical Center and chairman of the physician group Alliance for Patient Access, told attendees during a session at the Biotechnology Industry Organization International Convention.

NPC Seeking Proposals For CER Research On Health Care Decision Making

Fri, 08 Jul 2011 00:00:00 -0400

Focus of request for proposals is on current comparative effectiveness research and the health care decision-making environment, but organization is open to other research ideas.

Taking CER To The Doctor: AHRQ Academic Detailing Project Gets Under Way

Mon, 27 Jun 2011 00:00:00 -0400

When first introduced as a funding opportunity for some of the $1.1 billion put aside for comparative effectiveness research under the American Recovery and Reinvestment Act, using academic detailing as a way to disseminate CER findings raised some eyebrows.

Proliferation Of New Diabetes Drugs Prompts Call For Comparative Effectiveness Trials

Mon, 27 Jun 2011 00:00:00 -0400

Presenter at ADA meeting warns against "alarmist" reaction to imbalance in cancer rates for Bristol's SGLT-2 inhibitor dapagliflozin.

Feds Furnish $100 Million For Device Comparative Effectiveness Research

Mon, 27 Jun 2011 00:00:00 -0400

The Department of Health and Human Services has committed nearly $100 million to device and diagnostics studies out of the $1.1 billion designated by the 2009 economic stimulus package for comparative effectiveness research.

CER Dissemination: PCORI Could Help Raise The Bar For Clinical Guidelines

Wed, 01 Jun 2011 00:00:00 -0400

Roundtable panelists, including the chair of the Patient Centered Outcomes Research Institute's communications committee, discuss the future of disseminating results of comparative effectiveness research.

State of Comparative Effectiveness Research: Benchmark Survey

Wed, 01 Jun 2011 00:00:00 -0400

Comparative Effectiveness Research is a phrase with talisman qualities inside the Beltway -- ascribed with almost magical properties to improve product/treatment choices and drive down health care expenditures. Outside the political sphere, the meaning of the term and concepts about how to effect CER are less clear.

PCORI Chairman Says Institute Is A “Transformative Opportunity”

Mon, 30 May 2011 00:00:00 -0400

To a casual observer, it may seem that the Patient-Centered Outcomes Research Institute is moving slowly, but for Eugene Washington, chairman of PCORI’s board of governors, the group’s deliberations reflect a desire that the institute be more than just another driver of comparative effectiveness research.

FDA To Conduct Comparative Effectiveness Research With New Clinical Data Repository

Mon, 30 May 2011 00:00:00 -0400

FDA is on track to begin, next January, piloting use of its clinical trial data repository for comparative effectiveness research, the agency said at a recent advisory board meeting.

Experts Debate How To Get Word Out On Comparative Effectiveness Findings

Mon, 30 May 2011 00:00:00 -0400

As a national comparative effectiveness agenda is being constructed, the debate over how to spread the word on the results of the research is heating up.

PCORI Is A “Transformative Opportunity” – Chairman Washington

Mon, 23 May 2011 00:00:00 -0400

NEW YORK – To a casual observer, it may seem that the Patient-Centered Outcomes Research Institute is moving slowly, but for Eugene Washington, the chairman of PCORI’s Board of Governors, the group’s deliberations reflect the goal of having the body be more than just another driver of comparative effectiveness research.

CER Has Been A Part Of CMS Coverage Decisions In Recent Years – Avalere

Mon, 16 May 2011 00:00:00 -0400

CER Has Been A Part Of CMS Coverage Decisions In Recent Years – Avalere

Mon, 09 May 2011 00:00:00 -0400

During the health care reform debate, much concern was expressed that results of comparative effectiveness research from the Patient-Centered Outcomes Research Institute could play a key role in Medicare coverage decisions. But CER has already been considered in making Medicare coverage decisions for years, recent Avalere Health analysis of national coverage determinations issued by CMS points out.

FDA's Science Board To Review Comparative Effectiveness, Pharmacovigilance, Nanotech

Tue, 03 May 2011 00:00:00 -0400

The May 20 meeting follows a recent reorganization of the safety functions in the Center for Drug Evaluation and Research.

Equal Access To Data Needed For CER To Be Effective, NPC Exec Says

Mon, 11 Apr 2011 00:00:00 -0400

With the Patient-Centered Outcomes Research Institute beginning the early grant process and other data collection initiatives such as FDA’s Sentinel and Janus programs also underway, National Pharmaceutical Council Chief Science Officer Robert Dubois is recommending changes in policy that will allow equal access for industry and academia to data used in comparative effectiveness studies.

IoM Recommends Standards For Systematic Reviews Of CER

Mon, 04 Apr 2011 00:00:00 -0400

The Institute of Medicine is looking to the Patient-Centered Outcomes Research Institute to be the overseer of standards on how to conduct systematic reviews of comparative effectiveness research and is making a series of recommendations on what those standards should be.

PCORI Methods Panel To Define “Patient-Centered Outcomes Research”

Mon, 28 Mar 2011 00:00:00 -0400

When the Patient-Centered Outcomes Research Institute's Methodology Committee finished its presentation to PCORI's Board of Governors, one thing was clear: the committee is looking for something broader in “patient-centered outcomes research” than simply comparative effectiveness research.

First Order Of Business For PCORI Methods Panel: Define “Patient-Centered Outcomes Research”

Mon, 21 Mar 2011 00:00:00 -0400

When the Patient-Centered Outcomes Research Institute's Methodology Committee finished its presentation to PCORI's Board of Governors, one thing became clear: the committee is looking for something broader in its definition of “patient-centered outcomes research” than simply conducting comparative effectiveness research.

PCORI Lays Comparative Effectiveness Research Groundwork With Environmental Scans, Tier 1 Grant Process

Mon, 14 Mar 2011 00:00:00 -0400

The Patient-Centered Outcomes Research Institute board of governors approved two actions that are expected to form the foundation of the institute's future work: conducting environmental scans and developing the process for awarding “tier 1” grants.

Teenage Wasteland: Paying for New Drugs and Other "Adolescent" Technologies

Tue, 01 Mar 2011 00:00:00 -0500

The debate over comparative effectiveness research has focused heavily on standards of evidence to judge the relative value of different therapies and standards for when and how conclusions should drive coverage policy. Less attention has been paid to a more fundamental question: when should the value determination be made.

Premier Seeks Applicants For Comparative Effectiveness Studies

Mon, 28 Feb 2011 00:00:00 -0500

The selected studies will examine the correlation between product performance and health outcomes, with the peer-reviewed findings to be published in an abstract and disseminated to Premier alliance members and the broader health care community.

Premier Seeks Applicants For Comparative Effectiveness Studies

Mon, 28 Feb 2011 00:00:00 -0500

The Premier healthcare alliance, a group of hospitals focused on performance improvement, is seeking applications for its new program comparing the effectiveness of products and clinical interventions at its member hospitals.

AHRQ's Budgeted CER Activities Focus Mainly On Evidence Synthesis, Generation

Thu, 17 Feb 2011 00:00:00 -0500

The administration's 2012 budget proposal increases AHRQ funds for comparative effectiveness research by $600,000 to $21.6 million plus $24 million expected to be transferred from the Patient-Centered Outcomes Research Institute Trust Fund.

Capitol Hill In Brief

Mon, 14 Feb 2011 00:00:00 -0500

More comparative effectiveness clashes

House Committee Questions HHS On Spending Of Comparative Effectiveness Research Funds

Fri, 04 Feb 2011 00:00:00 -0500

Republican leadership in the House Energy and Commerce Committee is exercising its oversight authority to take a closer look at comparative effectiveness research activities