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2020, Number 2

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Rev Cubana Farm 2020; 53 (2)

A new methodology for safety surveillance during the pre-register development of immunotherapeutic products

Saumell NY, Sánchez VL, Suárez PY, Batista RM

Language: Spanish
References: 29
Page: 1-21
PDF size: 827.86 Kb.


ABSTRACT

Introduction: The safety surveillance process for a new immunotherapeutic product is carried out during its clinical development in order to guarantee an acceptable benefit-risk ratio.
Objective: To design and implement a new methodology for improving the safety surveillance process during the pre-registration development of immunotherapeutic products at the Center of Molecular Immunology.
Methods: A mixed qualitative-quantitative research was carried out. The theoreticalmethodological framework necessary for a new approach to the evaluation process was defined, and a methodology was designed and implemented for improving the process. This included the instruments and indicators designed and validated in a previous diagnosis of the process. A quasiexperiment was carried out for evaluating the impact of the implemented methodology. The softwares R and SPSS were used.
Results: The new designed methodology was structured with two 2 components: the systematic application of organizational actions (seven instruments and 16 indicators for evaluating the process, two new standardized operating procedures and two updated ones, continuous training of the involved personnel, and management of an integrated security base), as well as the introduction of methodological actions (disproportionality analysis for the detection of signals, and three alternatives for longitudinal data analysis). After the implementation, all the evaluated indicators were increased, but the time for sending notifications of serious events did not reach the standard value. The disproportionality analysis did not permit to identify any new product‒adverse reaction combination. The representation of the prevalence by treatment cycles of the main recurrent reactions allowed better description of the treatment effect over time.
Conclusions: The implemented methodology allowed the improvement of the process, by reaching most of the pre-established standard values, increasing the value of the indicators with respect to diagnosis, and providing new ways for describing the safety of immunotherapeutics over time.


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