Team of specialists that make up the XAVIA Clinics project. Photo: Alberto Medina Cruz
XAVIA Clinics receives the Provincial Award for Innovation 2016
Team of specialists that make up the XAVIA Clinics project. Photo: Alberto Medina Cruz
The Clinical Trials Management System, XAVIA Clinics, developed by the Development Center for Medical Informatics (Cesim), belonging to the University of Informatics Sciences (UCI), recently received at the Pedro Kourí Institute of Tropical Medicine, The Provincial award of Innovation (2016), granted by the Ministry of Science, Technology and Environment (Citma).
Due to its novelty, economic contribution and social impact in the Health sector, this product was recognized, allowing computerization of the design and conduction processes of clinical trials or Data Collection Notebook (CRD).
With a composition of 15 specialists who work in different roles within the project, it is developed the work of this team.
To know more details about the work of this group and the recognition they received, we interviewed the engineer Yasmani Ledesma Valdés, leader of the project.
- How did you come up with this software?
- The Management System for Clinical Trials arises from the need of the specialists of the Center for Molecular Immunology (CIM) to have a system to perform electronic data capture, eliminate double entry during the conduction of clinical trials and allow the remote transmission of this data between the national network of hospitals and this center.
- Currently, where is it used?
- It is being used in the CIM, as a promoter of these trials, where data from patients participating in clinical trials are collected. In addition, the computer system is in operation in all 15 provinces of the country, specifically in 141 polyclinics - for primary health care - and in 35 hospitals and specialized centers for secondary health care.
- What tests are already mounted in this system?
- Currently conducting 13 clinical trials including Phase I trials to Phase IV, with a total of 1 991 patients included, and is working on the design process of nine trials.
"XAVIA Clinics has concluded the design and conduct of four trials, including: the CIMAvax-EGF vaccine trial in the lung Phase IV predictor; Vaxira for the treatment of ovarian epithelial cancer; Vaxira for pediatric patients diagnosed with neuroblastoma or Ewing sarcoma and NacGM3 / VSSP as a subcutaneous immunopotentiator for the treatment of AIDS patients refractory to antiretroviral therapy, Phase I / II.
- Who evaluated the quality of this software in Cuba?
- It was released by the National Center for Software Quality (Calisoft), and evaluated and approved by the Center for State Control of Medicines, Equipment and Medical Devices (CECMED).
"This supports the quality and reliability of the use of XAVIA Clinics in a process as sensitive as clinical trials. The CECMED recommends expanding its use to all entities conducting clinical trials in the country, with national and foreign institutions.
- How much has this system contributed to the saving of foreign currency to our country?
- The use of XAVIA Clinicas has generated savings to the country of more than USD 1 million per year for the acquisition of software of this type, maintenance services, support and training of personnel.
"In particular the CIM has reported savings of more than 50,000 CUCs in 17 clinical trials for CRD sheet printing."
- Are there other institutions interested in this product?
- Following the results obtained in the I National Workshop on Data Management, the VI International Workshop on Design and Conduct of Clinical Trials and the accumulated experience of CIM specialists in the use of the system, there are several institutions in the country, Promoters of clinical trials, interested in this software among which are: the Finlay Institute of Vaccines, the National Center for Scientific Research (Cenic), the Center for Biomaterials Research, the International Clinic "Cira Garcia", among others.
- How many awards have you obtained so far?
- There are several, for example: the Recognition of Faculty 2 to the Applied Result of greater contribution to social development in the past year; Relevant Category in the Provincial Science and Technical Forum 2016; The Rector's Award for Scientific Merit in 2016 awarded by the UCI and the latter awarded by the Citma in Havana.
- What does it mean for the Xavia Clinic team to have received this recognition?
- Our team is a real pride, as it demonstrates the importance of the work we do every day to keep our system stable and thus contribute to the accurate and efficient development of clinical trials in the country, in the search for vaccines for The cure of diseases.
"It commits us even more to the economic development of the country, to continue working in the process of computerization
