scholarly journals The growing opportunity of clinical data management in Ukraine

Author(s):  
Sergey Glushakov ◽  
Volodymyr Boichuk

Many specialized positions, even entry-level, in the pharmaceutical industry require training above and beyond standard University degree programs. A shortage of specialized clinical data managers in Ukraine means private sector companies are developing internal resource training programs to deepen their pool of available candidates. Given the strong medical education system and established IT outsourcing industry, we believed developing a pool of talented clinical data managers within Ukraine was a feasible goal.The IT outsourcing industry is the second largest export service industry in Ukraine, and one of the main sectors in the economy. More than 50% of Ukraine's IT services revenue came from the United States, the rest mostly from the EU.[1] Ukraine has built a workforce adapted to IT outsourcing, but the lack of local professionals in the fields of clinical data management and clinical data science hinders similar growth in the clinical research sector. Ukraine has a well-established medical education system that trains its healthcare professionals in accordance with EU regulations. Hospitals are predominantly state-owned; the private medical sector is almost nonexistent. The academic and non-profit clinical research sectors are small in comparison to Western European countries, and opportunities for careers within them limited. This leads to a 'brain drain' of medical professionals from Ukraine to other countries in search of higher wages and professional advancement. With its strong education system and highly educated medical workforce, Ukraine is an attractive but under-utilised location for clinical studies. [2] There are approximately 30 clinical research sites in Ukraine handling preclinical through Phase IV studies. In December 2020 on clinicaltrials.gov there were 557 active or recruiting clinical trials listed taking place in Ukraine. Regulatory hurdles and approval timelines have greatly improved in recent years.Currently, when CROs wish to hire data managers to assist with local clinical trials in Ukraine, they have to hire non-specialists who must teach themselves on the job. At present there are no university courses or formal training programs within the country for clinical data managers.Following the success of the Clinical Statistical Programming training program developed by our team and offered since 2013 in partnership V. N. Karazin Kharkiv National University,[3] we recently launched an in-house clinical data management training program in partnership between leading Biometrics CROs Cytel and Intego Group. Upon program completion, students have the opportunity to transition into full-time employment. Ours is the first centralized training program for clinical data managers in the country. We already started a conversation with some of the country's leading universities to help them develop a formal educational program in clinical data management. Our internal training program will serve as a pilot and a proof of concept. We expect that many elements, such as curriculum, admission requirements, quality control, internships, etc., will successfully scale up in an academic environment. Our paper will discuss opportunities for the clinical data management sector in Ukraine, the challenges of recruiting data managers from the existing healthcare workforce, the region’s unique strengths, laws and regulations. We also discuss specifics of the internal training program, development of a course syllabus, and transitioning students from coursework into hands-on data management training.Article length: 8 pages. Article reference count: 9 references.---------------[1] AVentures. Software Development in Ukraine, Poland, Belarus and Romania in 2019.[2] Sinichkina L,  Smolina A,  Svintsitskyi V. Positive Changes for Clinical Trials in Ukraine. Applied Clinical Trials. December 2017.[3] Pirbhai E, Glushakov S. Development of a Clinical SAS University Training Program in Eastern Europe. PharmaSUG. 2015.

2014 ◽  
Vol 2 (2) ◽  
pp. 7-11
Author(s):  
SM Idris Ali ◽  
Md Humayun Kabit Talukder ◽  
Momena Khatun ◽  
Rowsan Ara Khanom ◽  
Md Abdal Miah ◽  
...  

Background Medical education in Bangladesh is poorly assessed and there is a general lack of documented knowledge about the challenges facing this field and the needs for its development. This study aimed to assess the need of medical education training or course for the teachers of medical colleges. Methods A quantitative study based on a self-administered questionnaire of a purposive sample of 204 teachers of different medical colleges was conducted from 1st July, 2011 to 30th June 2012 to explore their views regarding the training or course in medical education. Results The study revealed that majority (98.5%) of respondents showed their interest for training or course on medical education. Among them 61% preferred a regular course, 29% desired for training program and 10% for refresher training on medical education. Most of the respondents (68%) agreed that there are some barriers to participate in a training or course on medical education. Conclusions The existing medical education system face significant problems and it needs important and comprehensive improvements in or course on medical education. There is a need for further research in this field to explore the identified problems in a more in-depth manner in order to better understand of the problems and needs of training or course on medical education. DOI: http://dx.doi.org/10.3329/bjme.v2i2.18135 Bangladesh Journal of Medical Education Vol.2(2) 2011: 7-11


2007 ◽  
Vol 30 (4) ◽  
pp. 56
Author(s):  
I. Rigby ◽  
I. Walker ◽  
T. Donnon ◽  
D. Howes ◽  
J. Lord

We sought to assess the impact of procedural skills simulation training on residents’ competence in performing critical resuscitation skills. Our study was a prospective, cross-sectional study of residents from three residency training programs (Family Medicine, Emergency Medicine and Internal Medicine) at the University of Calgary. Participants completed a survey measuring competence in the performance of the procedural skills required to manage hemodynamic instability. The study intervention was an 8 hour simulation based training program focused on resuscitation procedure psychomotor skill acquisition. Competence was criterion validated at the Right Internal Jugular Central Venous Catheter Insertion station by an expert observer using a standardized checklist (Observed Structured Clinical Examination (OSCE) format). At the completion of the simulation course participants repeated the self-assessment survey. Descriptive Statistics, Cronbach’s alpha, Pearson’s correlation coefficient and Paired Sample t-test statistical tools were applied to the analyze the data. Thirty-five of 37 residents (9 FRCPC Emergency Medicine, 4 CCFP-Emergency Medicine, 17 CCFP, and 5 Internal Medicine) completed both survey instruments and the eight hour course. Seventy-two percent of participants were PGY-1 or 2. Mean age was 30.7 years of age. Cronbach’s alpha for the survey instrument was 0.944. Pearson’s Correlation Coefficient was 0.69 (p < 0.001) for relationship between Expert Assessment and Self-Assessment. The mean improvement in competence score pre- to post-intervention was 6.77 (p < 0.01, 95% CI 5.23-8.32). Residents from a variety of training programs (Internal Medicine, Emergency Medicine and Family Medicine) demonstrated a statistically significant improvement in competence with critical resuscitation procedural skills following an intensive simulation based training program. Self-assessment of competence was validated using correlation data based on expert assessments. Dawson S. Procedural simulation: a primer. J Vasc Interv Radiol. 2006; 17(2.1):205-13. Vozenilek J, Huff JS, Reznek M, Gordon JA. See one, do one, teach one: advanced technology in medical education. Acad Emerg Med. 2004; 11(11):1149-54. Ziv A, Wolpe PR, Small SD, Glick S. Simulation-based medical education: an ethical imperative. Acad Med. 2003; 78(8):783-8.


2019 ◽  
Vol 14 (3) ◽  
pp. 160-172 ◽  
Author(s):  
Aynaz Nourani ◽  
Haleh Ayatollahi ◽  
Masoud Solaymani Dodaran

Background:Data management is an important, complex and multidimensional process in clinical trials. The execution of this process is very difficult and expensive without the use of information technology. A clinical data management system is software that is vastly used for managing the data generated in clinical trials. The objective of this study was to review the technical features of clinical trial data management systems.Methods:Related articles were identified by searching databases, such as Web of Science, Scopus, Science Direct, ProQuest, Ovid and PubMed. All of the research papers related to clinical data management systems which were published between 2007 and 2017 (n=19) were included in the study.Results:Most of the clinical data management systems were web-based systems developed based on the needs of a specific clinical trial in the shortest possible time. The SQL Server and MySQL databases were used in the development of the systems. These systems did not fully support the process of clinical data management. In addition, most of the systems lacked flexibility and extensibility for system development.Conclusion:It seems that most of the systems used in the research centers were weak in terms of supporting the process of data management and managing clinical trial's workflow. Therefore, more attention should be paid to design a more complete, usable, and high quality data management system for clinical trials. More studies are suggested to identify the features of the successful systems used in clinical trials.


2019 ◽  
Vol 14 (1) ◽  
pp. 10-23 ◽  
Author(s):  
Aynaz Nourani ◽  
Haleh Ayatollahi ◽  
Masoud Solaymani Dodaran

Background:A clinical data management system is a software supporting the data management process in clinical trials. In this system, the effective support of clinical data management dimensions leads to the increased accuracy of results and prevention of diversion in clinical trials. The aim of this review article was to investigate the dimensions of data management in clinical data management systems.Methods:This study was conducted in 2017. The used databases included Web of Science, Scopus, Science Direct, ProQuest, Ovid Medline and PubMed. The search was conducted over a period of 10 years from 2007 to 2017. The initial number of studies was 101 reaching 19 in the final stage. The final studies were described and compared in terms of the year, country and dimensions of the clinical data management process in clinical trials.Results:The research findings indicated that none of the systems completely supported the data management dimensions in clinical trials. Although these systems were developed for supporting the clinical data management process, they were similar to electronic data capture systems in many cases. The most significant dimensions of data management in such systems were data collection or entry, report, validation, and security maintenance.Conclusion:Seemingly, not sufficient attention has been paid to automate all dimensions of the clinical data management process in clinical trials. However, these systems could take positive steps towards changing the manual processes of clinical data management to electronic processes.


1970 ◽  
Vol 8 (2) ◽  
pp. 189-199 ◽  
Author(s):  
Jong Sang Choi ◽  
Duck Joon Suh ◽  
Jong Yil Chai ◽  
Heechoul Ohrr ◽  
Ik Keun Hwang ◽  
...  

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