How Do We Teach Students to be Fair and Ethical Stewards of Health Care Resources?

	If Money and Medicine are Inseparable, How Do We Teach Students to be Fair and Ethical Stewards of Health Care Resources? Gretchen L. Schwarze, MD

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The educational resources for clinical trials research staff provided below are from reputable sources and are reviewed by the HICT Program.

System Requirements

• This course requires a minimum 1040 x 768 screen resolution
• The course contains an audio narrative that utilizes Flash. Download Flash player
• computer must have JavaScript enabled

Target Audience

A Web-based course for healthcare providers who are interested in becoming clinical trials investigators and including cancer clinical trials in their practice.

Course Content Overview

This Web-based course covers these topics:

• Evaluating the option of becoming a clinical trials investigator
• Registering and credentialing
• Strategies for establishing and training the research team
• Locating sources of funding and identifying an IRB
• Patient recruitment, enrollment and eligibility verification
• Record keeping and reporting requirements
• Quality assurance procedures
• Working with referring clinicians

Time

The estimated time to complete this course is 2 ¼ hours.

Accessible Format

Print a 508-compliant PDF of the entire course (494 KB). The course contains an onscreen transcript of the audio narrative. Look for the audio symbol in the upper right of the course.

The course also contains a complete audio transcript on each screen. To view the transcript, click on the transcript symbol.

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Training and Resources in Research Ethics Evaluation (TRREE)

TYPE OF TRAINING/TRAINING METHODS

TRREE is a free and open access online training program on research ethics and regulation. TRREE’s learning material is currently available in English, French, German, Polish and Portuguese. It also provides access to the national regulation in the participating countries. The training is modular. It includes an introduction to research ethics (module 1), a module on the role and responsibilities of Research Ethics Committees (module 2.1), several modules on the national regulation in given countries from the North and the South (module 3) and a detailed module on informed consent (module 4). TRREE has been recognized as continuing program by the Swiss Medical Association (FMH) and the Swiss Pharmacists Association (FPH).

TARGET AUDIENCE AND CHARGES

While some modules may focus on more specific training needs of research ethics committee members, or research teams including investigators, nurses, or study coordinators, the training is open to all and may be of interest to health authorities, funding agencies and universities, as well as to political authorities, patients and the media. Free of charges.

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Fundamentals of Clinical Trials – Online Training

These online training modules consist of recorded slide presentations prepared by David DeMets, PhD, Department of Biostatistics & Medical Informatics at the University of Wisconsin – Madison. They are intended to provide an overview of the fundamentals of clinical trials and can be viewed at your own pace.

Note: You will need to have the Adobe Flash Player installed to view these modules.

Clinical Trials Basics

This training module provides a brief introduction on various aspects of clinical trials.

Basics part 1: Types of studies, study questions, outcome measurements and study population choices (32 minutes)

Basics part 2: Study design, conduct and data collection (33 minutes)

Basics part 3: Study monitoring and analysis (24 minutes)

Clinical Trials Advanced

This series of lectures covers similar topics as the basics course above, but explores each topic in greater detail.

Advanced lecture 1: Background and history of clinical trials (35 minutes)

Advanced lecture 2: What is a clinical trial and why bother? (40 minutes)

Advanced lecture 3: Exploring the questions, responses and population choices of clinical trials (50 minutes)

Advanced lecture 4: Clinical trial design (37 minutes)

Advanced lecture 5: Sample size estimation (52 minutes)

Advanced lecture 6: Trial monitoring for safety and benefit (61 minutes)

Advanced lecture 7: Issues in data analysis (34 minutes)

Advanced lecture 8: Trial reporting (20 minutes)

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Smoking vaccine fails clinical trials, $4.1 million in taxpayer dollars down the drain

An experimental new anti-smoking vaccine has failed miserably in clinical trials, faring no better than a placebo shot at helping people to quit smoking.Produced in partnership with drug giant GlaxoSmithKline (GSK), Nabi Biopharmaceuticals’ NicVAX was intended to help people quit smoking by triggering the production of antibodies that would attach to nicotine and prevent the substance from reaching the brain — but the vaccine has proven to be nothing but non helpful medicine.

According to reports, the yearlong study involved 1,000 people that were given either NicVAX or a placebo shot, and who were tracked to observe smoking habits following treatment. Roughly 11 percent of patients who received the NicVAX shot quit smoking, but the same amount from the placebo group also quit smoking — in other words, there was no difference at all in quit rates between the two groups. Upon news of the failed Phase III trial, Nabi’s stock price dropped a massive 70 percent, and GSK’s dropped about one percent. But what is even more shocking is the fact that Nabi had used $4.1 million in taxpayer dollars to fund research for NicVAX. The company’s website openly discloses that the US National Institute on Drug Abuse (NIDA) had granted $4.1 million in funding to the company back in 2005 for the project.

Remember, both Nabi and GSK are private, for-profit drug companies, and GSK had a net income in 2010 of nearly $3 billion. And yet the US government decided to take Americans’ hard earned money and funnel it into a failed project that, if eventually “successful” (at least in terms of somehow gaining FDA approval, not in terms of actually working to “cure” smoking), will translate into $500 million in profits for Nabi, and possibly even more for GSK.

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Researchers discover exciting new line of stem cells by accident

The already exciting prospect of stem cell research has just got a little more exciting, with the discovery of a new line of “more robust and easily manipulated” embryonic stem cells, completely by accident.A team of researchers from the University of Missouri came across the new cell type during studies into the causes of pre-eclampsia, a rare and complex condition which affects only pregnant women. It requires emergency caesarian early on in pregnancy to save both mother and child and it’s causes are currently attributed to a variety of factors, including shallow placentas.

“We can use these new stem cells for future research to better understand how embryos are organised and what causes diseases like pre-eclampsia and other prenatal problems.” said Michael Roberts, a Curators Professor of Animal Science and a Professor of Biochemistry. “These new stem cells made us realise that embryonic stem cells exist in a number of different transitional states, and it should open the door for future stem cell research that is much more efficient.”

The stem cells, termed bone morphogenetic protein (BMP)-primed stem cells by the team, were accidentally discovered during the growth of placenta cells. As part of their study, Roberts and his colleagues were attempting to grow placenta cells from embryonic stem cells by adding a substance called BMP-4, a protein which helps define axes of growth in embryo development, for a shorter timeframe than had previously been studied. Instead of forming placenta cells, however, the stem cells grew into what was a previously unobserved state – “BMP primed”.

They found these cells were much easier to work with in the laboratory than traditional stem cells, due to easier growth and them expressing their genes in a similar way. Embryonic stem cells as a whole are of increasing interest in research, due their ability to develop into a number of different cell types such as muscle, bone or skin.

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