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Vose Consulting helps US-FDA win first court case based on risk analysis
Free update to ModelAssist 1.02
ModelAssist growing worldwide

Upcoming Course - only a few spots left!

 

Risk Analysis tip (a sample ModelAssist topic)

"Incorporating differences in Expert Opinion"

News
Vose Consulting helps US-FDA win their first ever court case based on risk analysis

Given concerns about human risk from using antibiotics in animals, in 2000, the US Food & Drug Administration (FDA) faced the question of whether to continue to allow use of fluoroquinolones in poultry, a common antibiotic used in the US and Europe to prevent diarrhea and increase growth. To address this, the FDA hired Vose Consulting to lead a team of scientists at the FDA to develop an appropriate risk analysis study including a quantitative risk analysis. Based on the team's work, in 2002 the FDA decided to withdraw approval for the drug as used in poultry.

In 2002, the decision was appealed by the drug manufacturer and Vose Consulting played a key role in responding to the technical challenges to the risk analysis in the ensuing legal dispute. Vose Consulting developed a strategy for the FDA's legal council in the very technical case and the judge decided in favor of the FDA.

As a result of his work on the case, David Vose received the Commissioner's Special Citation, the highest award offered by the FDA. On July 28th, 2005, FDA's Commissioner Lester Crawford issued a precedent-setting, final decision to withdraw approval for use of Cipro-like antibiotics in poultry (to see the FDA decision click here). This is the first time in approximately 35 years that an animal drug approval has been withdrawn on the grounds of its impact on public health.

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Free update to ModelAssist 1.02!

ModelAssist users can now download version 1.02 of ModelAssist by using the auto-update feature for ModelAssist for @RISK and ModelAssist for Crystal Ball. The latest update of ModelAssist includes, among others, topics on:

  • How to model rare event risks
  • Quick calculation of total impact of a set of risks
  • LogLaplace distribution

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ModelAssist Used Worldwide!

More and more people worldwide are using ModelAssist as their risk analysis template, training and reference tool. Download the free demo version of ModelAssist to see for yourself why people at companies such as IBM, American Express, Boeing, PricewaterhouseCoopers, GlaxoSmithKline, Unilever, ABB, Dow Chemical and Bank of America use ModelAssist.

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Upcoming Course - only a few spots left!
Animal Agriculture and Food Safety Risk Analysis Course

Vose Consulting will be holding its annual Animal Agriculture and Food Safety Risk Analysis from September 5th thru to 16th in Gent, Belgium. This course has an international reputation as being the most comprehensive and intensive available in the field. The course material has been updated to incorporate the latest advances in risk analysis, and forthcoming standards and regulations.

There are a limited number of places left in the course. For more information and a registration form, please visit http://www.voseconsulting.com/training_ahafsra.htm.

If you have a suggestion for topics of others courses or like to know more about our in-house courses, please contact us at .

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Risk Analysis Tip (a sample ModelAssist topic)
Incorporating Differences in Expert Opinion

The following Risk Analysis Tip has been drawn from material in ModelAssistT. ModelAssist users can consult the ModelAssist-references (in the form of Mxxx) for additional information. To read more About ModelAssist and get a free download of the demo version, click here.

Introduction

Expert opinion is an important source of information for quantifying model parameters and variables. Expert estimates can produce unrealistic distributions but they are often the only source of information available. Therefore, you need to follow a number of important principles to get the most reliable and unbiased estimate (see M0300). One common technique is to get more than one expert estimate for important parameters but this leaves the problem of incorporating any differences in expert opinion in to the model.

This Risk Analysis Tip will show you how to combine expert opinion the correct way and also give you tips on how to avoid errors.

Correct way of incorporating differences in expert opinion

Experts will sometimes produce profoundly different probability distribution estimates of a parameter. This is often because experts have estimated different things, made different assumptions or have accumulated different sets of information on which to base their opinions. Occasionally two or more experts simply genuinely disagree. How should you approach this problem?

The way to approach this problem is to treat the difference in opinion as another source of uncertainty. Therefore, the differences should not be discounted by, for example, taking the average of the opinions or the largest (or smallest) opinion. Instead, you need to create a composite distribution that reflects the range and emphasis of each opinion and confidence in the estimators.

Consider an example: Imagine that you have an important uncertain value in your model and that you ask three experts to estimate it. All three experts have the same information and it has been widely disseminated but you ask each one to estimate the parameter that you need to put in your model separately. Therefore, the experts don't sit together and decide what value they think the parameter should be. Instead, they discuss the information available together, and then separately estimate it. Of the three estimates you receive, two are PERT distributions (see M0361) and one is a General distribution (see M0203) that has a customized shape. These three distributions are plotted together below:

You can see they are different and you decide to weigh expert B (brown line) twice as much as expert A (red line) or C (blue line). You could have given them equal weightings but this is an example to show when you have more faith in B, for example, because perhaps she is closer to the project or more experienced.

The figure below shows the results of the two ways of modeling the combined expert opinion (correct and incorrect).

The correct technique to use is a Discrete distribution (see M0129), where the {xi} are the expert opinions and the {pi} are the weights given to each opinion according to the emphasis one wishes to place on them.

The spreadsheet with the correct model is provided here:

Combining opinions (for @RISK users),
Combining opinions 5.5- (for Crystal Ball 5.5- users),
Combining opinions 7.0+ (for Crystal Ball 7.0+ users).

Incorrect way

An often used but incorrect way of combining expert opinions is to multiply the expert opinions by their weights, sum the results and divide the outcome by the sum of the weights to normalize it.

This method is wrong is because the formula calculates a weighted average of the three opinions. Therefore, the model will always pick a value in the centre and will not give the same degree of spread that is shown with the discrete distribution. The reason why you want to use the discrete distribution is that at least one person believes that the true value should be as low as three and at least one person believes that the value should be as high as ten. As we see from the figure above (red line), the incorrect distribution does not include these values.

ModelAssist

  • The material within this 'Risk Analysis Tip' comes from one of the over 500 risk analysis topics available in ModelAssist, which gives a more detailed explanation of the above methods and any risk analysis techniques involved.
> Learn more about ModelAssist

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