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Background: Clinical Trials (CTs) remain the foundation of safe and effective drug development. Given the evolving data-driven and personalized medicine approach in healthcare, it is imperative for companies and regulators to utilize tailored Artificial Intelligence (AI) solutions that enable expeditious and streamlined clinical research. In this paper, we identified opportunities, challenges, and potential implications of AI in CTs. Methods: Following an extensive search in relevant databases and websites, we gathered publications tackling the use of AI and Machine Learning (ML) in CTs from the past 5 years in the US and Europe, including Regulatory Authorities' documents. Results: Documented applications of AI commonly concern the oncology field and are mostly being applied in the area of recruitment. Main opportunities discussed aim to create efficiencies across CT activities, including the ability to reduce sample sizes, improve enrollment and conduct faster, more optimized adaptive CTs. While AI is an area of enthusiastic development, the identified challenges are ethical in nature and relate to data availability, standards, and most importantly, lack of regulatory guidance hindering the acceptance of AI tools in drug development. However, future implications are significant and are anticipated to improve the probability of success, reduce trial burden and overall, speed up research and regulatory approval. Conclusion: The use of AI in CTs is in its relative infancy; however, it is a fast-evolving field. As regulators provide more guidance on the acceptability of AI in specific areas, we anticipate the scope of use to broaden and the volume of implementation to increase rapidly.
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Introducción: El entorno regulatorio mundial es cada vez más exigente para establecer, implementar y mantener el cumplimiento de las buenas prácticas clínicas (BPC). En Cuba, una respuesta necesaria derivada del desarrollo creciente de la industria farmacéutica y biotecnológica nacional fue la creación del Centro Nacional Coordinador de Ensayos Clínicos (CENCEC). Una de las misiones del CENCEC es preparar a las unidades-sitios clínicos seleccionados que realizan investigaciones clínicas, para su posterior certificación en BPC por la autoridad reguladora nacional, con la finalidad de avalar la calidad que corresponde al proceso de investigación clínica que redunda en una esmerada atención y protección al paciente objeto de estudio. Objetivo: Describir la estrategia del CENCEC para la preparación en BPC de los sitios clínicos seleccionados del Sistema Nacional de Salud (SNS) que participan en ensayos clínicos. Métodos: Se revisan más de 250 documentos normativos emitidos por Europa, Estados Unidos, Japón y los países nórdicos relacionados con aspectos prácticos y éticos para la implementación de las BPC...
Background: The global regulatory environment is increasingly demanding to establish, implement, and maintain the compliance with Good Clinical Practices (GCP). In Cuba, The National Coordinating Center for Clinical Trials (CENCEC) was created as a necessary response derived from the increasing development of the national pharmaceutical and biotechnological industry. One of the missions of the CENCEC is to prepare selected clinical units/sites that conduct clinical research for a further certification in GCP by the national regulatory authority in order to guarantee the quality that corresponds to the process of clinical research, resulting in a careful attention and protection of the patient under study. Objective: To describe the strategy of the CENCEC for the preparation of good clinical practices in the selected clinical sites of the National Health System (SNS) that participate in clinical trials. Methods: More than 250 regulatory documents issued by Europe, the United States, Japan and the Nordic countries, related to ethical and practical aspects for the implementation of good clinical practices, were reviewed...