|Year : 2018 | Volume
| Issue : 3 | Page : 35-41
Building capacity in critical care research coordination in Saudi Arabia: The role of the Saudi critical care trials group
Ahmad M Deeb1, Eman Al Qasim1, Lara Afesh1, Sheryl Ann Abdukahil2, Musharaf Sadat2, Yaseen M Arabi3
1 Research Office, King Abdullah International Medical Research Center; King Saud bin Abdulaziz University for Health Sciences; Ministry of the National Guard - Health Affairs, Riyadh, Saudi Arabia
2 King Saud bin Abdulaziz University for Health Sciences; King Abdullah International Medical Research Center; Intensive Care Department, Ministry of the National Guard - Health Affairs, Riyadh, Saudi Arabia
3 College of Medicine, King Saud bin Abdulaziz University for Health Sciences; King Abdullah International Medical Research Center; Intensive Care Department, Ministry of the National Guard - Health Affairs, Riyadh, Saudi Arabia
|Date of Web Publication||25-Feb-2019|
Yaseen M Arabi
Department of Intensive Care, MC 1425, College of Medicine, King Saud Bin Abdulaziz University, King Abdullah International Medical Research Center, Ministry of National Guard Health Affairs, P. O. Box 22490, Riyadh 11426
Source of Support: None, Conflict of Interest: None
Critical care research is growing around the world including Saudi Arabia. The objective of this review is to discuss the building capacity in critical care research coordination in Saudi Arabia as a part of the research strategy of the Saudi Critical Care Trials Group (SCCTG). The SCCTG was developed to promote high impact critical care research in Saudi Arabia and to facilitate collaboration in national and international clinical research. Well-organized coordination between all parties is necessary by the presence of qualified clinical research coordinator (CRC). Critical care has unique features that make clinical research conduct more complex and demanding. It is a high-risk area with increased potentiality of error or adverse events occurrence. Critical care providers such as critical care nurses, critical care pharmacists, respiratory therapists, critical care physiotherapists, or intensive care unit physicians with added skills may be appropriate candidates to handle CRC roles in critical care setting. These skills include but not limited to data collection, obtaining consent, patient assessment, patient screening for the study eligibility, data entry, ethics submissions, providing teaching regarding the study protocol and research topics to clinical staff, attending to regulatory requirements, and designing data collection tools. The SCCTG shall focus on training the clinical research coordination skills through providing specialized courses and workshops that enable different hospitals to conduct and participate in clinical research. It will also help developing network group to connect critical care CRCs in Saudi Arabia and worldwide.
Keywords: Clinical research, clinical research coordinator, clinical trial, Saudi Arabia
|How to cite this article:|
Deeb AM, Al Qasim E, Afesh L, Abdukahil SA, Sadat M, Arabi YM. Building capacity in critical care research coordination in Saudi Arabia: The role of the Saudi critical care trials group. Saudi Crit Care J 2018;2:35-41
|How to cite this URL:|
Deeb AM, Al Qasim E, Afesh L, Abdukahil SA, Sadat M, Arabi YM. Building capacity in critical care research coordination in Saudi Arabia: The role of the Saudi critical care trials group. Saudi Crit Care J [serial online] 2018 [cited 2021 Oct 27];2:35-41. Available from: https://www.sccj-sa.org/text.asp?2018/2/3/35/252892
| Introduction|| |
Clinical research is growing in the critical care field around the world. In recent years, there was a large number of high quality, multicenter, and multinational randomized controlled trials that have led to major changes in critical care practice. Clinical research opens doors to innovations, new treatments, new devices, enhancement in care, and cure for diseases and disability. The number of clinical trials has increased to attend to the large volume of new therapies and devices under development. In Saudi Arabia, clinical research is dramatically increasing in intensive care units (ICUs).,,,,, Such increase would require the availability of clinical research coordinators (CRCs).
Clinical research coordinators play a major role in clinical research coordination and management. Coordination of clinical research in ICU requires specific knowledge, skills, experience, and qualifications. In addition, ICU clinical research has its unique features, given the high-risk population and interventions. This review discusses the vital role of CRCs in clinical research, specifically in critical care settings; in addition, it presents a framework on how to build the capacity of clinical research coordination in the ICUs of the Kingdom to help moving forward the research agenda of the Saudi critical care trial group (SCCTG).
| The Need For The Clinical Research Coordinators|| |
Conducting clinical trials requires productive cooperation and engagement of multiple stakeholders to ensure the efficiency of the workflow carried out. These stakeholders include but not restricted to the following: the principal investigator and the site study team, sponsor, contract research organization, ethics committee, regulatory authority, data safety monitoring board, and study participants. In addition, maintaining essential documents of a clinical trial is essential for the successful management of the trial. These documents are required to evaluate the research teams compliance with the international standards of good clinical practice (GCP) and the applicable regulatory requirements. The proper filing, updating and maintaining of these documents before, during, and after the initiation of a clinical trial by a qualified CRC can greatly improve clinical trial management. Moreover, clinical trials contain multiple daily tasks which may continue over a long period (i.e., years). Although the principal investigators are required to allocate appropriate time to conduct clinical research, the coordination is best managed by a CRC, which does not only save time but it also improves the quality of conducting clinical trials.
In Saudi Arabia, critical care is expanding with major national and international clinical research projects and collaborations. Different types of clinical research projects are being conducted, including investigator-initiated clinical trials,,, and international multicenter-sponsored clinical trials.,,,, As a result, the SCCTG was formed to produce high-impact critical care research in Saudi Arabia and to promote collaborations in national and international clinical research. Furthermore, ICUs in Saudi Arabia have worked collaboratively with other networks from other countries such as the USA, Canada, Asia, Australia, and New Zealand. Accordingly, the role of CRCs is necessary for efficient study coordination not only within site but also with other sites and networks in multicenter studies. The SCCTG has conducted several important activities and has several projects in progress addressing important topics.,,,,,,,, For example, the SCCTG has led critical care research for the middle east respiratory syndrome resulting in several important projects.,,,,
| Clinical Research Coordination Competencies|| |
Clinical research coordinators should be qualified by education, training, and experience. In general, the CRCs generally have an academic degree in health care (nursing, medicine, pharmacy, etc.,) and training in clinical research. On the other hand, the presence of a certification from a professional certifying body is an addition for the qualification of the CRC. For example, the association of clinical research professional (ACRP) provides such certification for CRC as formal recognition of the clinical research profession.
The ACRP classifies the CRCs' competencies according to the level of the relevant performed tasks and exhibited knowledge as follows: entry level, intermediate level, and senior level. The entry-level CRC competencies are described as being foundation level focusing on the ability to perform basic tasks and to identify key aspects of clinical research. For the intermediate level, the CRC is expected to perform tasks independently, consistently, and accurately. In the senior level, the CRC exhibits advanced skills and knowledge that enable him/her to support, guide, train, demonstrate, or lead study team members conducting. In addition, the senior CRC contributes to the development of new processes, procedures, tools, and training to enhance clinical research activities through the competency domains and conducts quality control to check the work of others. At this level, the CRC is typically enabled to apply critical thinking and creative problem-solving skills across a wide variety of clinical studies. [Table 1] describes the main domains of the core competency guidelines for the CRCs as per ACRP.
|Table 1: Core competencies for the clinical research coordinator as per the Association of Clinical Research Professionals|
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In critical care research, Eastwood et al. ranked the needed skills for the critical care research coordinator as reported by CRCs worldwide as follows: research knowledge, problem solving skills, ability to identify ethical issues, objectivity, organizational and managerial skills, communication skills, teaching skills, ability to identify safety concerns, patient advocacy skills, assessment of critically ill patients, public speaking skills, and finally technical skills.
| Critical Care Research-Specific Skills|| |
In critical care, it is highly recommended for the clinical research coordinator to have sufficient knowledge about the common diseases in critical care. In addition, it is recommended to have knowledge about interventions commonly performed in critical care settings such as mechanical ventilation, renal replacement therapy, sedation, and vasopressors. Such knowledge is central for the study protocol execution and management. For that reason, a critical care nurse is typically an excellent fit for CRC in ICU settings. Other critical care providers such as critical care pharmacists, respiratory therapists, critical care physiotherapists, or ICU physicians may be other candidates to handle CRC roles and responsibilities depending on the type of the project.
Critically ill patients and critical care settings impose more complex and demanding clinical research, including, for example, daily follow-up, monitoring, and data collection. In addition, critical care setting is considered a high-risk area with high probability of error or adverse events occurrence. Furthermore, many of the study participants in critical care studies have limited decision-making capacity (due to their clinical status), which makes them vulnerable participants. This requires the CRC to be familiar with the related ethical guidelines.
Another unique and highly important aspect of critical care research is the informed consent process. Informed consent is an ongoing process, which starts before the participant's recruitment and continues until the study closes out. The responsibility of the researcher is to ensure that all the details of the study are explained clearly to the participant/legal surrogate, including the risks and benefits, and that participation is voluntary. However, decision-making in this complex setting is delicate, and the CRC should be familiar with approaching consent in such setting. In addition, the CRC should be familiar with different types of consent in critical care settings (e.g., prior consent, deferred consent, waived consent, consent to continue, and opt-out consent).
| The Role of Clinical Research Coordinator|| |
Clinical research coordinators responsibility is managing the studies holistically, providing high-quality data through proper screening and recruiting of participants, ensuring informed consent, collecting and recording data, and performing participant follow-up. In addition, CRCs have a major role in protecting human participants in clinical trials.,
A study showed that adding a research nurse to an ongoing clinical trial has significantly improved recruitment of eligible patients from 14% (40/281) during the year before the addition of the research nurse to 50% (126/253) after the addition (P < 0.001). The contributions of CRCs in providing a precise explanation of clinical trials to the participant and/or decision-maker have a high impact in developing trust and increasing assurance.
The role of CRCs is not clearly defined in the international regulation and guidelines (the International Council for Harmonisation-GCP [ICH-GCP] and the code of federal regulations). However, ICH-GCP stated that “the investigator should maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties” (ICH E6 4.1.5). This makes the CRCs responsibilities delegated by the principal investigator. These duties should be clearly documented in the delegation log. In general, we can summarize the tasks delegated to the CRC according to the study stage as shown in [Table 2].
|Table 2: Different clinical research coordinator tasks according to the study stage|
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In critical care research, Roberts et al. reported the most commonly performed tasks by >81% of CRCs in Australia and New Zealand as follows: ethics submissions, explaining the protocol to the staff, patient screening for eligibility, patient assessment, provision of education and support to patient and family, data collection/entry/transcription, attending to regulatory requirements, review protocol feasibility, collecting and processing biological specimens for local processing and international processing, managing study budgets, teaching research topics to ICU staff, and preparing study budgets. Similarly, Eastwood et al. described the top ten performed tasks by CRCs worldwide in critical care research as follows: data collection, obtaining consent, patient assessment, patient screening for study eligibility, data entry, teaching of protocol to clinical staff, ethics submissions, teaching of research topics to clinical staff, attend to regulatory requirements, and designing data collection tools.
| The Role Of Saudi Critical Care Trials Group In Building Capacity In Critical Care Research Coordination In Saudi Arabia|| |
The SCCTG was initiated to facilitate the conduct of critical care researches in Saudi Arabia and to promote national and international collaboration. It represents a platform to exchange experience and to discuss research proposals among researchers. The SCCTG has an important role in building capacity for critical care research coordination in Saudi Arabia. The SCCTG will focus on training interested candidates on clinical research coordination skills. This may be achieved through courses and workshops. These training programs aim at providing candidates with the needed basic research knowledge and the required skills to manage and coordinate clinical research projects in critical care settings. The following are examples of competencies that would need to be covered: overview of study designs; overview of drug development process; study team and research organization roles and responsibilities; ethical principles of clinical trials; study protocol; informed consent process; screening, recruitment, and retention; investigational drugs management; participants' follow-up; clinical trials safety profiles; data management; quality control and assurance; essential documents; preparing for site visits, monitoring, and inspection; clinical trials preinitiation, initiation, and close out; and common critical care research variables and outcomes (severity of illness measures and common physiologic variables in the ICU).
In addition, the SCCTG can facilitate the exchange of experiences among CRCs in Saudi Arabia by organizing regular meetings. Finally, the SCCTG can help in developing a network group to connect CRCs working on critical care research in Saudi Arabia and worldwide.
| Conclusion|| |
Critical care research is increasing in Saudi Arabia. Having qualified CRCs is vital for efficient study coordination and management. The SCCTG may play an important role in building capacity in critical care research coordination in Saudi Arabia.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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