Textual Content Analysis in the Diagnosis of Failures in the Drug Development Process

Authors

Keywords:

qualitative analysis, knowledge discovery, failure diagnosis, drug development, pharmaceutical industry.

Abstract

Introduction: Drug development on a global scale has low efficiency and effectiveness. Several reasons are listed as causes, but they are rarely supported by studies based on systematically collected data. This makes difficult designing effective solutions.

Objectives: To propose the application of textual content analysis to the study of a company's technical documentation, to diagnose failures in the pharmaceutical development process, and to illustrate its use and usefulness in a case study.

Methods: Analysis of the letters issued over a 10-year period by the State Center for the Control of Drugs and Devices in response to requests for authorization of clinical trials or for sanitary registration of drugs developed by the Center for Molecular Immunology.

Results: The coding of the text and the measurement of the frequency of appearance of phrases showed that the most frequent failures are related to the categories “product” and “clinical studies”. It was found that the regulatory agency made more comments about the control of results than about the design tasks, and that the “justification of quality specifications” is the most repeated failure. By quantifying the co-occurrence of the failures, the possible interdependence or common root cause between different types of failures could be noted.

Conclusions: The discovery of new knowledge, based on the analysis of the texts, allowed to identify solutions and mitigate the causes of the detected failure, and to reduce the costs in time and resources in the development of the products.

Author Biographies

Lisel Viña Rodríguez, Centro de Inmunología Molecular, Dirección de Calidad

Dirección de Calidad, biotecnólogo de 1er nivel, responsable de la actividad científica y de innovación

Patricia Sierra Blázquez, Centro de Inmunología Molecular, Dirección comercial.

Dirección comercial, Asesora comercial y de negocios

Mercedes Delgado Fernández, Escuela Superior de cuadros del Estado y del Gobierno

Rectora de la Escuela Superior de Cuadros del Estado y del Gobierno: La Habana, Cuba

Regla de la Caridad Herrera Ruíz, Centro de Inmunología Molecular, Dirección de Calidad

Departamento de Calidad de la Vicedirección de Investigación Desarrollo, especialista de Aseguramiento de la Calidad

Yamira Busutil Sosa, Centro de Inmunología Molecular, Dirección de Calidad

Dirección de Calidad, Directora de Calidad

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Published

2024-10-15

How to Cite

1.
Viña Rodríguez L, Sierra Blázquez P, Delgado Fernández M, Herrera Ruíz R de la C, Busutil Sosa Y. Textual Content Analysis in the Diagnosis of Failures in the Drug Development Process. Rev. cuba. inf. cienc. salud [Internet]. 2024 Oct. 15 [cited 2024 Dec. 25];35. Available from: https://acimed.sld.cu/index.php/acimed/article/view/2309

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