The Challenge…
The Human Health Care has a very high priority in Cuba. It includes the development and extensive use of the radiation medicine techniques for the diagnosis and therapy of the diseases with the higher incidences on the local population such as oncological, cerebrovascular, cardiovascular disorders and other sicknesses. Therefore, on the last years new nuclear medicine (NM) techniques have been introduced in the clinical practice and high-tech equipment has been procured and installed including about 10 hybrid PET-CT and SPECT-CT systems.
The clinical efficacy and safety of these techniques depend on several key aspects such as the competence of the human resources, the creation of suitable conditions at the NM facilities and the development, validation and availability of adequate clinical SOPs. Another very important requirement to ensure the excellence of the provided diagnostic and therapeutical services to patients is the availability of suitable radiopharmaceuticals, according to the possibilities of the new technologies and to the needs of the new clinical services.
The introduction in the country of radiopharmaceuticals which are well-known around the world but they are not locally available yet, sometimes require to perform adequate non-clinical and clinical studies to evaluate and validate their safety and efficacy as a mandatory step for their registration. These studies must be performed according to the good practices as it is recommended in well-established guidelines of international organizations.
The project…
The International Atomic Energy Agency coordinated and sponsored, in agreement with the Cuban government, the Technical Cooperation project CUB6026 entitle “Strengthening capabilities for non-clinical and clinical evaluation of radiopharmaceuticals according to good practices”; its general goal was to enhance the diagnosis and therapy services to patients undergoing nuclear medicine studies. The project was addressed to support the introduction of lacking radiopharmaceuticals in the local clinical practice and the development of new labeled molecules produced at the local bioengineering and pharmaceutical institutions.
The project activities were leaded by the Center of Isotopes; they focused on strengthening the infrastructure of local nuclear medicine facilities in charge of driving clinical researches and also of local labs in charge of performing non-clinical studies, with new equipment and technologies. Other specific objectives were to enhance the qualification, training and competence of human resources, as well as to establish and standardize the required SOPs, according to the good practice requirements and considering the current state of the art on this field.
The impact…
The upgraded facilities and the installed equipment are ready to be used according to good practice requirements for the evaluation of new radiopharmaceuticals and also to provide different clinical and pre-clinical services.
Upgraded NM facilities and new hybrid system SPECT-CT-PET AnyScan TRIO installed
The nuclear medicine areas were significantly improved with the support of the IAEA that allowed to procure and install important high-tech equipment, as well as instruments and means to enhance the radiation protection of patient, staff and public members, plus clinical or physical phantoms which are relevant components to assure the safety and efficacy of the established procedures with the installed hybrid SPECT-CT-PET system. The installed multi-modality system has also allowed to increase the number and variety of NM examinations offered to patient coming from the national health care system.
Education and training of local human resources was strongly supported by the IAEA in key topics to ensure the quality and safety of the non-clinical and clinical researches.
Several fellowships and scientific visits were sponsored by the Technical Cooperation program, and 6 international experts visited and advised the specialists from the local institutions, providing them with in site practical training; they also shared their experiences and knowledge in several workshops with more than 100 local participants. Improved key areas during the CUB6026 project activities. On the other hand, Standardize Operational Procedures (SOPs) for non-clinical and clinical researches were created and validated during the project activities. All of them were approved by local scientific committees and implemented in the clinical practice at hospital or labs levels
Summarizing, excellent outcomes have been obtained as result of the coordinated IAEA TC project between the IAEA and the Cuba government allowing to organize new clinical and non-clinical researches and to increase the quality and safety of the offered NM services to the Cuban patients