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An Approach to Medical and Clinical Pharmacology Clinical Research Practices at Capa Campus: a Good Clinical Practices (GCP) Training Model

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An Approach to Medical and Clinical Pharmacology Clinical Research Practices at Capa Campus: a Good Clinical Practices (GCP) Training Model e-Book AANN APPROACHAPPROACH TOTO MMEDICALEDICAL ANDAND CLINICALCLINICAL PPHARMACOLOGYHARMACOLOGY CLINICALCLINICAL RRESEARCHESEARCH PRACTICESPRACTICES ATAT CCAPAAPA CAMPUS:CAMPUS: A GOODGOOD CCLINICALLINICAL PRACTICESPRACTICES ((GCP)GCP) TRAININGTRAINING MODELMODEL Dr. Meral Demir, MSc, PhD Published: 23-12-2019 | ISBN: 978-81-943057-5-0 002 Copyright: © 2019 Demir M, et al. This is an open-access e-book distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Title: An approach to medical and clinical pharmacology clinical research practices at Capa Campus: A Good Clinical Practices (GCP) training model Author(s): Demir M1*, Dizdar Y2, Bebek N3, Akkaya V4, Tukek T4, Gürol AO1,5, and Saip P6,7 Affl iation(s): 1Msc,, PhD, Department of Medical Pharmacology and Clinical Pharmacology, Istanbul Faculty of Medicine, Istanbul University, Fatih, Capa 34093, Istanbul, Turkey 2MD, PhD, Assistant Professor, Department of Radiation Oncology, Institute of Oncology, Istanbul University, Fatih, Capa 34093, Istanbul, Turkey 3MD, PhD,Professor, Department of Neurology, Istanbul Faculty of Medicine, Istanbul University, Fatih, Capa 34093, Istanbul, Turkey 4MD, Professor, Department of Internal Medicine and Emergency Internal Medicine, Istanbul Faculty of Medicine, Istanbul University, Fatih, Capa 34093, Istanbul, Turkey 5MD, PhD,Professor, Department of Immunology, Aziz Sancar Institute of Experimental Medicine, Istanbul University, Fatih, Capa 34093, Istanbul, Turkey 6MD, Professor, Department of Clinical Oncology and Medical Oncology, Institute of Oncology, Istanbul University, Fatih, Capa 34093, Istanbul, Turkey 7MD, Professor, Department of Internal Medicine and Medical Oncology, Istanbul Faculty of Medicine, Istanbul University, Fatih, Capa 34093, Istanbul, Turkey Subjects: Medical Sciences Received: 04 December, 2019 | Accepted: 20 December, 2019 | Published: 23 December, 2019 *Corresponding author: Dr. Meral Demir, MSc, PhD, Department of Medical Pharmacology and Clinical Pharmacology, Istanbul Faculty of Medicine, Istanbul University, Millet Street, Fatih, Capa 34093, Istanbul, Turkey, Tel: +902124142000-32414, +9005307343088; Fax: +902124142052; E-mail: [email protected], [email protected] ISBN: 978-81-943057-5-0 | ISBN Date: 7.7.2020 DOI: https://dx.doi.org/10.17352/ebook10116 ORCID: https://orcid.org/0000-0002-6994-4275 Citation: Demir M, Dizdar Y, Bebek N, Akkaya V, Tükek T, et al. (2019) An approach to medical and clinical pharmacology clinical research practices at Capa Campus: A GoodClinical Practices (GCP) training model. Peertechz Publications, ISBN: 978-81-943057-5-0 An approach to medical and clinical pharmacology clinical research practices at Capa Campus: A Good Dr. Meral Demir, MSc, PhD, Turkey Clinical Practices (GCP) training model ISBN: 978-81-943057-5-0 doi: https://dx.doi.org/10.17352/ebook10116 003 Table of Contents 004 1. Abstract 005 2. Abbreviations 006-009 3. Background i. The addition of a new lesson to the curriculum ii. Content of the practices iii. Creating resources for practice iv. Developing a practices evaluation model v. Targets and evaluation 010-021 4. Materials and Methods vi. Content of lesson and resources vii. First-semester education viii. Formal structure of the measurement and evaluation form of fi rst-semester education ix. Second-semester education x. Formal structure of the measurement and evaluation form of second-term education xi. Statistical analyses 022-023 5. Results xii. Questionnaire Result xiii. Incoming suggestions 024-027 6. Discussion xiv. Determination and evaluation of the subjects of the practices xv. Lesson load and satisfaction xvi. Educational model and evaluation of group schoolwork xvii. Gains and future goals 028 7. Conclusion xviii. Ethics approval and consent to participate xix. Availability of data and materials xx. Author’s contributions 029 8. Acknowledgements 030-031 9. References Dr. Meral Demir, MSc, PhD, Turkey An approach to medical and clinical pharmacology clinical research practices at Capa Campus: A Good ISBN: 978-81-943057-5-0 Clinical Practices (GCP) training model doi: https://dx.doi.org/10.17352/ebook10116 04 1 ABSTRACT Background: Developing Good Clinical Practices (GCP) skills in early years of medical education markedly beneits medical students in taking part in research. The aim of the study is to improve medical students’ skills for “from Writing the Research Protocol to presentation” training through engaging them in at least one research before graduation with this newly created sample of clinical research education model. The model will includes Experience-Based (ExBL), Team-Based (TBL) and rational “GCP Lesson” in the pre-graduate medical education curriculum in the future. Methods: Third grade medical students were evaluated for two years with development of new GCP education model. A list over 500 drugs was created by using scientiic sources and databases. The “Evaluation-Feedback Form” consisting of written feedback and questionnaire was prepared. The “QR-Code” application was used. The questionnaire study with 156 students was included. Both the new GCP model and research infrastructure were also explained. The helpful technological application was discussed. Results: After this practice, many of the students (78.2%) found the lessons to be encouraging for future research. More than 75% of the students stated that they would like to take part in clinical research conducted in the future. The feedback shows that these practices increased self-conidence of participants (82.1%) and contributed to forming a young researcher community. Conclusion: The necessity of allocating the share of students in the international research network and success of this model was reported. Including a reward system would support scientiic research on the model’s beneits to the students. An approach to medical and clinical pharmacology clinical research practices at Capa Campus: A Good Dr. Meral Demir, MSc, PhD, Turkey Clinical Practices (GCP) training model ISBN: 978-81-943057-5-0 doi: https://dx.doi.org/10.17352/ebook10116 05 2 ABBREVIATIONS GCP; Good Clinical Practices, Educators Abbreviation; AOG; Ali Osman Gürol, MD; Meral Demir, NB; Nerses Bebek, PS; Pınar Saip, TT; Tufan Tükek, VK; Vakur Akkaya, YD; Yavuz Dizdar. Edu; Educator/s, Min; Minute, SN; Student Numbers, Stu; Student. Dr. Meral Demir, MSc, PhD, Turkey An approach to medical and clinical pharmacology clinical research practices at Capa Campus: A Good ISBN: 978-81-943057-5-0 Clinical Practices (GCP) training model doi: https://dx.doi.org/10.17352/ebook10116 06 3 BACKGROUND The addition of a new lesson to the curriculum The need for the placement of a care-clinical research curriculum in medical education was an ongoing international issue [1]. In Turkey, the “Good Clinical Practices (GCP) Lesson” related to clinical research [2], was not included in the curriculum of pre-graduate medical education. However, in post-graduate medical education, the basic education of GCP is provided for all parties. This education is necessary for both the formation of a researcher identity and for area speciic use in students’ future careers. For instance, “GCP Education” has been provided in speciic ields, such as for training the Members and Candidates of the Clinical Research Ethics Committee with the permission and participation of the Ministry of Health, Turkish Medicines and Medical Devices Agency [3]. This education is held in accordance with legal regulations and program content, and is conducted in cooperation with faculty, oficials of institutes, research centers, health authorities (such as the Turkish Medicines and Medical Devices Agency and the General Directorate of Health Services), The Scientiic and Technological Research Council of Turkey, other public institutions and organizations, as well as sponsors (clinical research companies, pharmaceutical companies, contracting research organizations, other industry organizations, and other funding sources). The irst studies on this educational model and long-term educational programs were prepared at the department of Medical and Clinical Pharmacology by Yağız Üresin (YÜ), Meral Demir (MD), and the educators in these practices in 2011. This model also provides the translational education in each area by involving all parties. Studies on including GCP Lesson in the pre-graduate medical education curriculum were carried out at relevant university departments. Following radical changes in the health system, options and consensus shaped the studies and meetings on whether new research infrastructures should be formed within the university, if necessary. The outcome of the meetings demonstrated a need to include students in clinical research, while including other researchers and employees. Moreover, clinical research training for Medical and Clinical Pharmacology should be included in the curriculum in earlier years of the medical education, following the recommendation of the department of Medical Education to implement it on the third semester. The idea of inclusion of “GCP Lesson” into the curriculum was irstly brought to the agenda in the 2015-2016 academic year, followed by studies conducted at the department. Since 2015, the educators have been taking the necessary steps, such as submitting a project proposal for of the European Union (EU) to include this lesson into curriculum. Dean
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