HE Institute.

Which Outcomes Matter in Solid-State Oncology?


Global Outcomes Group

Considerations About Evidence – Video Interviews

NPC asked the panelists for their insights on the challenges of developing and using evidence

AHRQ: Development of Quality Criteria To Evaluate Nontherapeutic Studies of Incidence, Prevalence, or Risk Factors of Chronic Diseases: Pilot Study of New Checklists

Utilizing Health Outcomes Data to Drive Company Decision-Making: Interview With Kevin Mayo

Interview covering trends and major challenges in HEOR.

Analysis Paralysis: How to Get the True Measure of Clinical Trials.

Remember, know WHAT you are measuring and WHY you are measuring it. (Source: InPharm, July 20, 2011)

A Process for Robust and Transparent Grading of Study Quality

Critical appraisal, assignment of a grade for methodological quality of individual studies, and subsequent grading a body of evidence addressing a specific question are essential activities of conducting comparative effectiveness reviews.

Using Market Exclusivity Incentives to Promote Pharmaceutical Innovation

The number of drugs entering the US pharmaceutical market is at a low point. At the same time, demand for innovative therapeutic alternatives has been rising in numerous fields, including antibiotics for multidrug resistant organisms and drugs for tropical diseases prevalent in low-income settings. The growing gap between the need for new pharmaceuticals and their development and approval for use in clinical care has drawn the attention of policymakers from diverse sources, including academia, industry, and government. (Source:NEJM 2010, Vol. 363, No. 19, pp. 1855-1862)

The 7 Deadly Sins of Resume Writing, by Suzanne Bohen, Executive Recruiter

Suzanne Bohen is an experienced search consultant with Emerson Professionals. Emerson is a boutique search firm with practices in the medical device, academic, and healthcare vertical markets. Suzanne focuses on reimbursement and health economics professionals in the medical device industry. To contact, email Suzanne@emersonprof.com.

Rise Of The Pharmaceutical Un-Sales Force

States such as Pennsylvania and South Carolina are funding this “academic detailing” as a tool to reduce those governments’ prescription drug-related health care expenses. (Source: Forbes, 4/25/11)

GE, Thomson Reuters Collaborate on Clinical Research Analytics

A joint effort by GE and Thomson Reuters will allow researchers to view both health care claims and clinical data to see how treatments will affect various patient populations. (Source: eWeek.com)

Industry Experience of Multi-Stakeholder Early Advice Consultations, PPT by J. Anderson

Presentation at ISPOR Europe, Nov. 2011, by James S. Anderson, MA, MBA, European Partnerships Director, Government Affairs, Public Policy and Patient Advocacy, GlaxoSmithKline, Brentford, UK

GE Healthcare Expands Commitment to The Health Management Academy GE

Healthcare announced it will expand its collaboration with The Health Management Academy over the next 5 years to implement best practices to lower healthcare costs and improve outcomes. (Source: WSJ Digital Network)

Health Economics Data in Turkey (Linkedin Group) Türkiye Saglik Ekonomisi Verileri Grubu

There are more than 300 members now from industry, government and academia. It's a growing platform to share your news, exchange our ideas and request information

Developing and Testing a Tool for the Classification of Study Designs in Systematic Reviews of Interventions and Exposures

Emphasis on understanding the comparative effectiveness of health care interventions has increased attention on the applicability of research. As a result, systematic reviews aiming to inform clinical practice have expanded beyond randomized controlled trials, which have limited generalizability, to include nonrandomized studies

Generalisability of Clinical Registers Used for Drug Safety and Comparative Effectiveness Research: Coverage of the Swedish Biologics Register M Neovius, et al. March 2011, Annals of the Rheumatic Diseases

Patients with adult onset rheumatoid arthritis (RA) were identified in the National Patient Register and the Swedish Rheumatology Quality Register, including the ARTIS cohort of patients exposed to biological agents

NCCN Oncology Risk Evaluation and Mitigation Strategies White Paper: Recommendations for Stakeholders

Managing drug safety and developing drug safety systems is an ongoing, critically important challenge for all involved in manufacturing drugs, regulating drug use, pre- scribing drugs, dispensing drugs, and consuming drugs. Risk Evaluation and Mitigation Strategies (REMS) are the newest tool of the FDA to help manage and ensure safe drug use.(Source:Philip E. Johnson, MS, RPh; George Dahlman; Kirby Eng, RPh;et.al)

Tis The Season for Drug Trend Reports

Educating Physicians: A Call for Reform of Medical School and Residency

The report recommends focusing more on learning outcomes, incorporating more clinical experiences early in medical education, and offering more opportunities for medical students to train in teams with nursing and other health-care students. The report also calls for a more individualized approach to medical education and training.

Comparisons Of FDA And EMA Risk Management Requirements For Recently Approved Products

Overview of Risk Evaluation and Mitigation Strategies (REMS) and Risk Management Plans (RMPs) in US and Europe.

Doctors tend to prescribe drugs that pharmaceutical companies promote

Pharmaceutical companies spent $57.5 billion on pharmaceutical promotion in the United States in 2004. The industry claims that promotion provides scientific and educational information to physicians. While some evidence indicates that promotion may adversely influence prescribing, physicians hold a wide range of views about pharmaceutical promotion.

Regulatory Actions on the Off-Label Use of Prescription Drugs:

The statement's provocative recommendations include the imposition of requirements that (a) the off-label drug should be "irreplaceable for treatment of the patient," that is, no drug labeled for the indication is available; (b) the off-label use must be "submitted and approved by the hospital's pharmacotherapy committee and hospital ethics committee" except in emergency situations; and (c) informed consent for off-label use must be obtained from the patient or a legal representative. (Source: JMCP October 2010 Volume 16 Issue 8, Authors: Kathleen A. Fairman, MA, and Frederic R. Curtiss, PhD, RPh, CEBS)

Science Based Medicine: Exploring issues and controversies in the relationship between science and medicine

Definition of Health Economics from University of Groningen, The Netherlands.

Health economics is a sub-discipline of economics and studies the allocation of scarce resources among alternative healthcare programs or strategies for the promotion, maintenance and improvement of health. Health economics studies how healthcare and health-related services, their costs and benefits, and health itself are distributed among individuals and groups in society. Health economics is concerned with the formal analysis of direct and indirect costs and benefits that are a consequence of a health care intervention, program or strategy. The science of health economics has significantly progressed in recent years. Although a lot of disagreement among health economists existed in the early nineties, over the recent years more consensus on methodology has been reached. This development resulted in a standardised approach, allowing valid comparisons of studies in different fields of health care and across countries. The main study types used in economic evaluation are cost-effectiveness (CEA) and cost-utility analysis (CUA) in which the incremental net costs of a programme are related to the health benefits.

Variations in health care: The good, the bad and the inexplicable

Variations in health care in the NHS are a persistent and ubiquitous problem. But which variations are acceptable or warranted

FDA: Don’t believe everything you read on drug studies

A popular pharma BLOG that is read by a lot of people again and again published content from such studies on Avandia and even went as far as to interview a former FDA official causing a lot of damage to the brand at a time when a scientific approach was needed.

Sales Force of the Future

How to Negotiate Salary

This is an often asked about and largely misunderstood topic amongst professionals at all levels. There are two critical times in everybody's career when compensation is a very important topic for discussion - when you have your performance review and when you are interviewing for a new position.

Spending on new drug development

Updates annual drug development expenditures. Average expenditure on drugs in human clinical trials is around $27m per year, with $17m per year on drugs in Phase I, $34m on drugs in Phase II and $27m per year on drugs in Phase III of the human clinical trials. (Source: Christopher Paul Adams and Van Vu Brantner, Health Economics, Feb. 26 2009)