Planning and organizing research

MARKO TURINA Zurich, Switzerland

How many of participants actually perform research,

clinical or other?

Research costs money: associates’ salaries, devices, lab space,

analyses, animals, etc.

Where to get finances?

Actual and Projected Growth in NIH Research Grants: FY 1950-2006

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1950 1955 1960 1965 1970 1975 1980 1985 1990 1995 2000 2005

Fiscal Year

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Budget 2006: 112 075 965 076 €

RELATIVE CITATION INDEX RATING

Non-Governmental research support and role of venture

capital is assuming increasing importance in biomedical

research

Getting venture

investment in European

biotechnology depends on being in the right place

Industry-supported research: a two-edged sword

• Industry-supported research is essential in some areas of medicine: oncology, clinical pharmacology, immunology, invasive cardiology etc.

• Such funding can lead to the profound conflict of interest.

• In most of the studies, supported research delivers the expected results.

INDUSTRY-SUPPORTED RESEARCH IS BECOMING EXCEEDINGLY IMPORTANT

Funding and trial outcome; Ann Pharmacother Buchkowsky 2004

INDUSTRY-SUPPORTED RESEARCH OFTEN DELIVERS THE EXPECTED RESULTS!

Funding and trial outcome; Ann Pharmacother Buchkowsky 2004

DiMarco, NEJM 2003

6/11 authors of these recommendations have a major conflict of interest

Most of us have conflicts of interest (According to Andy Wechsler)

• Who paid for your trip here?

• Who is paying for your dinner tomorrow…how about last week?

• Do you have a grant from industry?

• Who supports your research laboratory?

• Who provides support for your trainees?

• Are you paid for giving talks?

You have some interesting data and want to publish them: say 300

aortic valve replacements in poor LV function without mortality (?)

First, check you data carefully: are your results really true? Are your mortalities assessed according to current guidelines (every editor will ask you this question, unless you stated it in text):

Guidelines for reporting mortality and morbidity after cardiac valve interventions. Cary W. Akins, D. Craig Miller, Marko I. Turina, Nicholas T. Kouchoukos, Eugene H. Blackstone, Gary L. Grunkemeier, Johanna J.M. Takkenberg, Tirone E. David, Eric G. Butchart, David H. Adams, David M. Shahian, Siegfried Hagl, John E. Mayer, and Bruce W. LytleJ. Thorac. Cardiovasc. Surg., Apr 2008; 135: 732 - 738.

Adequacy Of Follow-up

In clinical research, adequate follow-up is essential for reaching meaningful results, especially in small number of patients, or in low incidence of end-points.

Example: 3/30 patients dying @ 1 year after a certain procedure, but only 24 are available for follow-up. If 3 missing patients are not alive, your estimated mortality of 10% jumps to 20%, error of 100%.

Example: In a series of 200 patients @ 1 year after valve replacement, your 90 % survival can be widely wrong if you assessed only 80 % of your patients, and you censored all missing data.

Today, there are no excuses for missing important information in the

published literature

Thorough search of literature is essential before preparing a scientific publication (no sense in reinventing the wheel):

• CTSNet journals• HighWire Press• Medline• Ovid• Pubmed

For a young surgeon with academic ambitions, there are two possible fields of research:

• Lab research work, either with experimental animals, or with various laboratory methods of analysis.

• Clinical research (patient studies, operative techniques, etc.)

For an ongoing researcher with little or no previous experience in science, there are some simple, universally valid rules:

• You need a competent mentor. Check his track record: his previous students which earned a degree or promotion, published cited papers, etc.

• Prepare yourself with additional formal or informal education: courses in statistics, lab techniques, genetics, biochemistry, engineering, etc.

• Plan a study period (1 – 2 years) in US – key to success for many top academic surgeons in Europe

..and that i was loyal to truth and

to right: bob dylan04/19/23 42

Why Observe???????

“Observations are useless until they have been interpreted. The analysis of experimental data forms a critical stage in every scientific inquiry – a stage which has been responsible for most of the foolishness and fallacies of the past”

E. Bright Wilson, An Introduction to Scientific Research.

..and that i was loyal to truth and

to right: bob dylan04/19/23

..and that i was loyal to truth and to right: bob dylan

43

Richard Feynmann

“The first principle is that you must not fool yourself….and you’re the easiest person to fool”

Surely you’re joking, Mr. Feynmann

Emerging field in clinical science, of special interest for young

researchers:

TRANSLATIONAL SCIENCE

Translational medicine is a medical practice based on interventional epidemiology. It is regarded by its proponents as a natural progression from Evidence-Based Medicine. It integrates research from the basic sciences … with the aim of optimizing patient care and preventive measures ….

Wikipedia definition

ESSENTIALS FOR AN ADVANCED PROGRAM IN CARDIO-THORACIC SURGERY

Claude Lenfant, Circulation 2003

THE TEN COMMANDMENTSFor ongoing scientists

1. Thou shalt have none other gods than Science2. Thou shalt not make to thyself false graphs3. Thou shalt not take the name of Science in vain4. Remember that thou keep holy the Seminar day5. Honor thy Professor and Supervisor6. Thou shalt do no murder against thy colleagues7. Thou shalt not commit adultery in the laboratory 8. Thou shalt not steal data9. Thou shalt not bear false witness against thy fellow

workers10. Thou shalt not covet thy neighbor’s ideas

triggle@buffalo.edu