Comparative Effectiveness from Elsevier Business Intelligence

Inflammatory Bowel Drugs To Go Head-To-Head With PCORI Funding

Mon, 13 May 2013 00:01:27 -0400

A number of drug-related comparative effectiveness research projects are approved for PCORI-sponsored research in its second funding cycle. Health IT-related projects also get attention as the institute spends more than $88 million on 51 projects.

PCORI To Fund Development Of Data Networks For Comparative Effectiveness Research

Mon, 29 Apr 2013 00:00:49 -0400

The Patient-Centered Outcomes Research Institute plans up to $68 million in grants to develop two types of national data networks: clinical data research networks and patient-powered research networks.

Sliding Perception Of CER Importance Not Concerning To PCORI’s Selby

Mon, 25 Mar 2013 00:01:13 -0400

PCORI Executive Director Joe Selby says decline in perception that comparative effectiveness research is “very important” to stakeholders in annual National Pharmaceutical Council survey “makes sense,” adding that results offer a realistic appraisal of expectations on the future of CER.

E-Health Records Could Help CER Data Meet Regulatory Standards – FDA’s Woodcock

Mon, 04 Mar 2013 16:55:01 -0500

Electronic health records have the promise of being able to generate trial data that could be used in FDA’s regulatory environment, FDA’s Janet Woodcock says in an editorial in the Journal of Comparative Effectiveness Research.

Flu Vaccines Likely To Remain Immune From Comparative Effectiveness

Mon, 25 Feb 2013 00:00:10 -0500

CDC’s Advisory Committee on Immunization Practices adds four recently-approved flu vaccines to its recommended list of products, but the committee chair expresses doubt that there could ever be data to make preferential recommendations.

Flu Vaccines Likely To Remain Immune From Comparative Effectiveness

Thu, 21 Feb 2013 21:30:01 -0500

CER “Substantial Impact” Expected in Three-to-Five Years: NPC’s Annual Comparative Effectiveness Survey

Thu, 21 Feb 2013 00:00:00 -0500

CER is slowly beginning to enter the public lexicon. Respondents to the National Pharmaceutical Council annual survey on comparative effectiveness report being more familiar with CER now than two years ago; but they still see the major impact several years away – not right on the horizon.

AHRQ Comparative Effectiveness Strategy Could Shift As Director Clancy Steps Down

Mon, 11 Feb 2013 00:00:38 -0500

Carolyn Clancy, who has served as director of the Agency for Healthcare Research and Quality for over 10 years, will stay in the post until a successor is named in the coming months.

United Health, Mayo Clinic Collaborating On Comparative Effectiveness Venture

Mon, 04 Feb 2013 00:02:18 -0500

Health insurer and hospital giant collaborate via data-sharing for comparative effectiveness research effort, with plans to focus on devices.

AHRQ Comparative Effectiveness Strategy Could Shift; Director Clancy Stepping Down

Thu, 31 Jan 2013 23:30:01 -0500

Carolyn Clancy, who has served as director for over 10 years, will continue on until her successor is announced, which is expected in the coming months.

FDA’s Temple Suggests Alternative Study Designs For Comparative Effectiveness

Fri, 18 Jan 2013 17:00:06 -0500

The CDER deputy director expresses surprise that studies assessing individualized responses to treatments from the same pharmacologic class or differences in a particular side effect are not conducted more frequently.

CER Credibility Hinges On Having Criteria For Using Results In Medical Decisions – National Health Council

Mon, 10 Dec 2012 00:01:23 -0500

National Health Council President Weinberg calls for the development of criteria, with the involvement of patients and patient organizations, to measure the usability of comparative effectiveness research as a means of improving its credibility.

Payers Reluctant To Leverage Comparative Effectiveness To Deny Coverage

Mon, 19 Nov 2012 14:00:00 -0500

Just learning about the results of comparative studies does not move payers to deny coverage of targeted services based on the experiences so far of the New England Comparative Effectiveness Public Advisory Council.

Payers Reluctant To Leverage Comparative Effectiveness To Deny Coverage

Mon, 19 Nov 2012 00:00:00 -0500

Patient Focus Could Shield PCORI From Controversy When Findings Contradict Accepted Standards

Mon, 12 Nov 2012 00:00:00 -0500

Having patients involved in all facets of the research process could help protect the Patient-Centered Outcomes Research Institute from controversy should research findings contradict generally accepted standards of care, speakers at a comparative effectiveness summit said.

Health Technology Assessments Should Help Prioritize CER – Journal Authors

Mon, 22 Oct 2012 00:00:00 -0400

While health technology assessment’s role primarily is to aid clinical and policy decision-making, it also has the potential to help prioritize the comparative effectiveness research agenda as well as inform trial designs, according to a recent article in the Journal of Clinical Oncology.

Oncology CER Needs Common Language, Data Collection Standards

Mon, 22 Oct 2012 00:00:00 -0400

Several articles in a comparative effectiveness research-themed issue of the Journal of Clinical Oncology highlight the need for CER to use common language and data collection standards to boost the value and usefulness of the research.

Additional Standards Needed To Make CER Meaningful And Adoptable, Case Study Shows

Mon, 15 Oct 2012 00:00:00 -0400

What started out as an exercise to show how comparative effectiveness research could be quickly adopted and help improve health outcomes ended up revealing that there remains a long way to go.

OMOP May Seek To Partner With Mini-Sentinel On Drug Safety, PCORI On Outcomes Research

Mon, 03 Sep 2012 00:00:00 -0400

The drug industry-funded Observational Medical Outcomes Partnership may seek collaboration with high-profile public-private drug safety and comparative effectiveness research initiatives.

Revamp CER Strategy For Cardiovascular Disease, Policy Center Advises

Mon, 13 Aug 2012 00:00:00 -0400

Center for Medical Technology Policy report explores challenges of gathering stronger comparative effectiveness research on devices that diagnose or treat cardiovascular disease.

E-Health Records Not Ready For Prime Time In Research, Disparities In Adoption Suggest

Tue, 31 Jul 2012 16:44:11 -0400

Researchers looking to use electronic health records may have to wait a bit longer before EHRs become a viable tool for comparative effectiveness research, based on disparities in the location of EHR adoption. A GAO report finds the highest adoption of EHRs in the South and in urban areas.

NIH Appropriations Flat In House Subcommittee Mark, But Chair Calls It An Increase

Wed, 18 Jul 2012 17:30:00 -0400

Rep. Rehberg says focusing NIH spending on basic research instead of other purposes is effectively a boost; committee battles over funding for comparative effectiveness research.

PCORI Methodology Report Emphasizes Transparency

Mon, 18 Jun 2012 00:00:00 -0400

The long awaited report contains 60 standards to guide comparative effectiveness research, and says researchers should publicly register their studies and share protocols and results.

Comparative Effectiveness Researchers See Need For Unique Set Of Principles For Oncology

Mon, 18 Jun 2012 00:00:00 -0400

A group of researchers is planning to publish a set of comparative effectiveness research principles that address the unique challenges of the oncology field. Panelists at the recent ISPOR conference described their approach to the development of those principles.

Regulators Not Ready To Get Behind Most “Pragmatic Trials” Before Approval

Mon, 11 Jun 2012 00:00:00 -0400

FDA’s Temple and the EMA’s Eichler are skeptical about offering drug sponsors incentives to conduct pragmatic clinical studies prior to marketing approval as a way to help generate comparative effectiveness research more quickly.

Cost Effectiveness Analysis In CER: Perhaps Not So Controversial After All?

Mon, 11 Jun 2012 00:00:00 -0400

Recent examination of cost effectiveness analyses conducted as part of comparative effectiveness research reveals that CEA and CER were in agreement about 70% of the time.

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 00:30:00 -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 00:00:03 -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.

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