Key-words:
Dubai - education - Harvard - Middle East - research - trials
Introduction
The interest in conducting clinical trials in MENA is expected to continue rising
in the future. On the one hand, MENA offers a large market, more patients, a variety
of diseases, and higher site productivity at lower costs. On the other hand, several
MENA countries are steadily developing their clinical trials regulations and infrastructure
to attract more clinical studies
There is a general paucity in medical research productivity in the Arab countries.
It has been estimated that the Arab world produces 189 publications per 1 million
of population, which is almost a quarter of the value for other world countries.[[1]] The growing interest in pharmaceutical business in the MENA region has not been
accompanied by a comparable increase in participation in clinical trials.[[2]] One of the plausible reasons is the lack of proper research infrastructure and
training.[[3]] Research methodology training has recently been incorporated in regional medical
and nursing schools in undergraduate level, while other senior staff may have acquired
research training as part of their postgraduate academic degree requirements. This
leaves a large proportion of practicing professionals to their personal interest to
pursue training in that domain. The doctors' attitudes and challenges to undertaking
research particularly in clinical practice have been highlighted by our group in a
recent survey from the MENA region.[[4]]
Currently, many pharmaceutical companies, universities and other Clinical Research
Organizations and health authorities organize series of lectures and workshops on
various aspects of clinical research to in-house employees or interested stakeholders;
however, very few offer structured training programs to interested health care providers
and scholars.
Perhaps in the MENA region only 2 nondegree certification programs are available.
The Scholars in Health Research Program summer certificate is a 7-week long program,
delivered by Clinical Research Institute of the American University of Beirut, that
covers fundamental skills in the essential disciplines to conduct research, namely
epidemiology, biostatistics, research ethics, library sciences/informatics, and involves
hands-on training in the analysis and reporting of large health related datasets in
Non-Communicable Diseases.[[5]] The second well-established program is the Introduction to Clinical Research Training
(ICRT) - Dubai program offered by Harvard Medical School.[[6]]
Recently, Harvard Medical School in collaboration with Ministry of Health of Egypt
has announced a new 6-month online program titled Clinical Scholars Research Training
(CSRT) primarily targeting clinicians and health-care educators practicing Egypt.[[7]]
Conference Highlights
The course and its objectives
ICRT program, developed by Harvard Medical School and conducted in Dubai, provides
learners with the foundations in designing, conducting, and implementing clinical
research studies. It progresses from developing research questions and testing hypotheses
to interpreting and communicating research results to writing organized manuscripts
and delivering engaging presentations. The program's skills-based, peer-to-peer blended-learning
approach covers topics during the intensive six-month curriculum including epidemiology,
biostatistics, STATA programming, and study design, as well as ethical issues, scientific
communication, clinical trials, and research leadership concepts. The overarching
goal of the Clinical Research Foundations program is to equip the next generation
of researchers with the essential skills to become independent clinical research investigators
and to assume leadership and mentorship positions throughout their academic careers.
The specific educational objectives of the course are provided in [[Table 1]].
Table 1: The Specific, measurable, attainable, relevant, and time educational objectives of
the Introduction to clinical research training - Dubai 2020
Learning model
The learning in based on two models; The Blended Learning model and Team-based Learning
model. The blended-learning approach combines the traditional face-to-face teaching
methods of workshops and recorded online lectures supported by interactive webinars,
to form an integrated instructional approach. All recorded lectures and webinars are
made accessible throughout the course and 6 months after the completion of the program
enhancing opportunities for knowledge retention. The team-based learning is essential
since collaboration is a critical ingredient in scientific discovery promoting team
approaches to solving research problems. Here, students will learn how to work in
teams and develop networks. Students are divided into globally diverse groups to collaborate
with each other on assignments during the live workshops and in between. As the program
in 2020 took place during the COVID 19 pandemic, the second workshop was conducted
virtually in contrast to the first one which was delivered in person just before the
lockdown early March.
Program overall structure
The interactive workshop curriculum was focused on the hands-on the development of
clinical research skills. Key elements of the workshop have included practical exercises
in manuscript and research proposal development, critical assessment of the medical
literature, and practical training on STATA statistical software using real-life data
sets from Framingham Heart Study and the Digitalis Investigation Group Study. In addition,
training in mentorship, academic career development, and leadership were covered during
the course of the program.
Modules and assessment
The five modules of the course are listed in [[Table 2]]. Online lectures covering topics in epidemiology, biostatistics, study design,
scientific writing, dissection of scientific papers, management and leadership Interactive
webinars designed to expand or review lecture topics. The course material delivered
by faculty from schools across Harvard University. Each module is followed by an MCQ-based
quiz reinforcing the learning experience. Further assessment was carried out through
the completion of two team assignments enriching group collaboration in summarizing
and critically appraising a specified original publication from Ethics point of view
in the first assignment, and presenting a novel research question using a feasible
innovative approach in the second. Individual assessment was done through presenting
page 1 of a research proposal including the research question, relevance, background,
connecting the hypotheses and aims with the research questions.
Table 2: The five module of the course
Limitations
Despite the high standards of the course, few limitations are noteworthy. First, a
lot of the emphasis was made on training for conduct of clinical trials. This aspect
of research may not be widely needed and even if it is conducted, a lot of the control
of the studies would be guided by the sponsors and international bodies. Therefore,
more emphasis would have been better made on conducting research in the real world,
appraising other designs using various examples of published work from the region.
Second, a major limitation is related to the use of the statistical package choice,
and spending great deal of time on explaining programing codes rather than interpretation
of results, which is far more important for non-statisticians. STATA software, though
a robust tool, is rarely used in the MENA region, and use of a more commonly used
package such as SPSS would have been a wiser choice.
Many participants have expressed their dissatisfaction with the high cost of the program
as many were in their early stages of their medical career. Obviously, the restraint
imposed by the current pandemic state has made face to face interaction rather impossible.
Otherwise an additional physical workshop dedicated to hands-on training on the statistical
package would have been much worthy. Including certification in Good Clinical Practice
within the course of 6 months could have added greater value to the program encouraging
candidates to take part in ongoing research initiatives. Finally, more emphasis should
have been put on writing skills and submissions, choice of journals, responding to
reviewers, finalization of manuscripts, and be wary of predatory journals and publishers.
Finally, many participants were expecting more training on how to conduct and mange
and large databases in multicenter studies, however, this exercise was lacking.
Final Remarks
The program is one of its kind in the region. In spite of the limitations imposed
by the COVID 19 situation, the program has attracted many candidates to actively participate
during this difficult period, reflecting the need for research training. As an introductory
course to clinical research with flexible online component, ideally suited for busy
health care providers with limited experience in medical research, ICRT is highly
recommended.
Authors' contributions
Both authors have attended the 2020 program, and have contributed equally to the information
presented.
Compliance with ethical principles
Not applicable.
Reviewers:
Not Applicable (Commissioned Report)
Editors:
Elmahdi Elkhammas (Columbus OH, USA)
Salem A Beshyah (Abu Dhabi, UAE)
