SBRAM (Sarac's Benefit-Risk Assessment Method)

1. Description

SBRAM is a multi-criteria method, using some basis of the MCDA. To allow comparison across different benefit-risk categories, criteria are weighted on a scale of 1 (low), 2 (medium), and 3 (high) according to their importance. In order to reduce the impact of subjective judgments, scores are assigned to each criterion on the basis of the data wherever possible.

2. Evaluation

2.1 Principle

The eight steps of SBRAM are:

establishing the decision context;

identifying the benefit-risk criteria;

weighting the criteria;

scoring the criteria;

evaluating uncertainty;

calculating weighted scores;

discussing results;

formulating an overall conclusion.

• The -1, 0, 1 system, representing inferior, equivalent, superior (to a comparator), cannot distinguish between two treatment alternatives that are all superior (or all inferior) to the comparator, without direct comparisons data.

• Mixed treatment comparison method is suggested to compare alternative without direct comparisons data.

• Weights and scores are multiplied, and the results are not integrated but are visualized individually.

• Uncertainties are dealt with qualitatively from the scoring charts or quantitatively using bootstrapping.

• The proportion of patients who experience a clear effect with the drug is used to define the clinical relevance.

2.2 Features

• Although supported by statistical analysis, the method is more qualitative in nature to properly allow for uncertainties and differences in opinions.

• It serves to focus the assessment on the clinical and toxicological issues.

• This criterion for clinical relevance measures the fractions of patients helped by the drug rather than demonstrating an improvement for the average patient.

2.3 Visualisation

Two visualisations have been suggested for use with SBRAM:

• Scoring chart is used to visualize the data under the SBRAM's scoring technique.

• Tornado-like diagram Tornado-like diagram is used to visualise the uncertainties associated with the weighted scores

2.4 Assessability and accessibility

• The scores in this approach are based on descriptive statistics whenever possible.

• It is important any information and interim decisions are fully maintained and clearly presented in the final decision process.

• The underlying statistical analysis should also be documented in a clearly understandable form.

• SBRAM is designed for the purpose of evaluating new drugs in the preparation of regulatory submission.

• This method was tested in the Telithromycin case study.

3. References

[1] Sarac SB, Rasmussen CH, Rasmussen MA, Hallgreen CE, Soeborg T, Colding-Jorgensen M, et al. Balancing benefits and risks: Data-driven clinical benefit-risk assessment. 2011.