Implications of Relatives on Benefit-Risk Ratio

Implications of Relatives on Benefit-Risk Ratio

Benefit-risk ratio attempts to establish the potentials of a process to benefit a patient as compared to its possible risks. The ratio is important in establishing the effect of medical procedure or product on the patient, the methodology is part of a procedure inhealthcare especially when bringing a new product to market. Bernabe, Thiel and Deldan assessed the implications of involving a patient’s relatives in a benefit-risk ratiovaluation. The research used interview method to gather the required information, a sample respondent population of 15 from the scientific committee members. To give credibility to the results, ten of the respondents were from the stateregulatorywing while five were patient representatives.

Interview questions focused on the role of befit-risk ration assessment criteria used by the committees, the involvement of relatives as third party and contribution of family members to the process, these questions facilitate the generation of enough data to respond to the research question. The study concluded that contribution of relatives to benefit-risk ratio is a variable of the benefits and risks involved. Relatives make the greatest contributions when both risk and benefits are high, almost equal and when low. The research also concluded that relatives contribute to the benefit-risk ratio tasks by providing criteria upon which the weights and value are assigned to particular activities. Patient relatives provide the perspective to judge the risk or benefit acceptability to the process, thus, the research acknowledgedrelatives as critical to the success of befit-risk ration assessment.





Bernabe, R., Thiel, G.,& Delden, J. (2014). Patient representatives’ contributions to the benefit–risk assessment tasks of the European Medicines Agency scientific committees. British Journal of Clinical Pharmacology78(6), 1248-1256.

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