Abstract

Throughout the 1980s, Cuban researchers at the country’s biotech campus known as the Scientific Pole were making innovative discoveries and began developing unique therapies and vaccines unavailable elsewhere in the world. The pace and level of innovation meant prioritizing the establishment of a dedicated, internationally‐certified institute for clinical trials. These and other accomplishments in science and related sectors, coupled with statistics revealing that 53% of all scientists in Cuba are women, prompted MEDICC Review to publish a series of interviews with outstanding Cuban women in science, technology and medicine. In this, the second installment in the series, we spoke with Dr Maria Amparo Pascual, a biostatistician, researcher and professor, and the driving force behind the design and establishment of Cuba’s Clinical Trials Coordinating Center (CENCEC). From 1991 to 2014, Dr Pascual served as founding director of CENCEC. During that time the center implemented internationally-recognized good clinical practices (GCP), launched the National Clinical Trials Coordinating Network to support trials overseen by CENCEC, began conferring master’s and doctoral degrees in clinical trials; initiated a quality management system for all trials (receiving ISO 9001 certification in 2008) and created the Cuban Public Registry of Clinical Trials—a bilingual, WHO–accredited Primary Registry, the first in the Americas. In 2013, the BBC recognized Dr Pascual as one of the most infl uential female scientists in Latin America for her achievements, including becoming Cuba’s first biostatistician and her work at CENCEC. In 2014, Dr Pascual stepped down as director of CENCEC but didn’t slow down or leave the center she helped build, literally from the ground up: she currently serves as management consultant and researcher at CENCEC, as well as director of the Research Ethics Evaluation System Project there. She is also a professor in the Center’s clinical trials graduate degree program and of bioethics at the Medical University of Havana. She is finishing her doctoral dissertation on clinical trials in Cuba and the founding and evolution of CENCEC.

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