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CAPACITY BUILDING

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INTRODUCTION

Gap between the demand in clinical trials/research professionals and the workforce is very wide and that is not sparing any country or region in the world. This situation is even worse in Low- and Middle-Income Countries where, due to the lack of training, majority have skills below international standards.

To generate reliable evidence concomitantly in different settings through Multiregional Clinical Trials (MRCTs), research professionals need, in addition to their scientific background, to acquire knowledge that aligns with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice, Ethical and Regulatory requirements and other international standards.

We strive to establish and accelerate the quality of human resources and infrastructure to promote a self-sustaining clinical research environment mainly in countries in Asia and Africa.

OBJECTIVES

  • To reinforce capacity of clinical research and trials professionals in Asia and Africa
  • To develop a network of clinical research professionals who will collaborate and discuss on an ongoing basis various theme relevant to clinical research and specific health needs of their countries.
  • To build independent and autonomous organizations capable of conducting both locally-initiated and global studies.

OUR COLLABORATING INSTITUTIONS

AFRICA

The Democratic Republic of The Congo

  1. University of Kinshasa
  2. National Institute of Biomedical Research (INRB)

Sudan

  1. Mycetoma Research Center, Khartoum
  2. National Institute of Biomedical Research (INRB)

SOUTH EAST ASIA

Thailand

  1. Faculty of Medicine, Siriraj Hospital, Mahidol University
  2. Faculty of Tropical Medicine, Mahidol University

Vietnam

  1. Bach Mai Hospital
  2. Cho Ray Hospital

Indonesia

  1. Infectious Diseases Hospital Sulianti Saroso
  2. Universitas Indonesia
  3. Mochtar Riady Institute for Nanotechnology
  4. Siloam Hospitals

Philippines

  1. University of The Philippines
  2. Corazon Locsin Montelibano Memorial Regional Hospital
  3. West Visayas State University

LOCAL TRAINING

THE PHILIPPINES

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Series of online training have been implemented in the Philippines under the supervision of the University of the Philippines National Institute of Health.

From October 4-7,2021, 102 researchers from different hospitals within the country completed the “Principles of health research ethics and good clinical practice” program.

From February 23-24,2023, the course on Introductory course to Trials and design was held.



INDONESIA

Two major activities were organized under the supervision of the Universitas Indonesia from October 25-29,2021.

Online training for Clinical Investigators on the theme “How to conduct a good quality clinical trial” during which in addition to the live sessions, a platform for e-learning using a moodle system was used. A total of 55 Physicians and Pharmacists completed the training.

In addition, an open online conference entitled “Patient safety in Clinical Trials” gathered 333 delegates from Regulatory authority, pharmaceutical company, hospitals and Universities.

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THAILAND

A hybrid type both online and face to face training was held under the supervision of the Siriraj Institute of Clinical Research from November 9-27,2021.

The main theme of the training was “strengthening of clinical trial in the Midst of COVID-19: the Rise of Digital Revolution”.

This was a 6 days training divided into seven sessions namely; Remote monitoring, home health care, The future of clinical trials, E-consent process, electronic data collection and Management, Direction and regulation of Generic Formulations, Audit preparation and CAPA management and, Communication and Time management. The attendance record is presented in the Table 1, with majority (426) of participants joining the Electronic Data collection and Management course.

Table 1. Attendance status during Thailand training

No Course Participants
1 Remote monitoring 224
2 Home health care: The future of clinical trials 243
3 e-consent process 362
4 Electronic data collection and Management 269
5 Direction and regulation of Generic Formulations 39
6 Audit preparation and CAPA management 37
7 Communication and Time management 35
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VIETNAM

Two programs were developed and conducted under the supervision of the Bach Mai Hospital.

From December 4-16,2021, an online training program under the theme “Clinical research methods” during which 109 participants from 18 hospitals within the country participated as registered participants and 659 others as guest participants was conducted.

For the second part, nine participants were selected based on the quality of their protocol content and joined from March 4<sup>th</sup> to March 11 a workshop on how the protocol review is conducted by the ethical review board and what are the practical steps to the implementation of a study.

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DEMOCRATIC REPUBLIC OF THE CONGO

From August 15 to 19, 2022, the University of Kinshasa through his clinical pharmacology and pharmacovigilance unit in collaboration with the National Institute of Biomedical research (INRB) implemented a 4 days training for clinical trials professionals.

This face-to-face training on the theme “Clinical trial training for investigator” had put together 87 participants from different backgrounds including physicians, pharmacists, and biologists who are already clinical trial professionals for some and those who are willing to be clinical trial investigators.

In addition, a conference on the theme “Towards medical innovation from the bench to bedside” opened to a wider public was conducted as a satellite event of the training.

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SUDAN

Fifty participants joined a 5 days’ workshop for clinical trials professionals organized by the Mycetoma Research Center in Khartoum.

The workshop conducted from November 1-9, 2022 had the objective to excite, motivate and train young researchers interested in clinical trials to produce critical mass of scientists with the goal to establish a Pan-African Clinical Trials Training Platform. The workshop was a distinctive occasion to have an overview of the different aspects of the clinical trials process and its pros and cons. Pioneering researchers and scientists in clinical trials and research facilitated the workshop and shared their knowledge and experience.

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E-LEARNING COURSE

An advanced training course for clinical research professionals selected from the group of clinical research professionals training in their home countries, registered 29 participants who intend to lead Investigator-initiated trials in their respective countries.

The e-learning course was composed of 7 lessons including pre-clinical studies, Regulation 1&2, Biostatistics and epidemiology for health care researchers, Data management, and The course was launch on November 2021 and closed on May 31, 2022.

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FROM THE PARTICIPANTS

 

Dr_Yves

“The training was very organized; the topics/lectures/schedule was strictly followed; the lectures were appropriate; the site visits to the other institutions were inspiring; the staff were very friendly and they took care of the group very well; it was a great experience; we all learned a lot from the training.” Dr. Lula Yves Ntamba, University of Kinshasa, DR Congo, MRCT STP 2019

 

Dr_borimas

"There so many things that I found interesting in this program. It provided me the opportunities to observe research facilities, work culture, and examples of cutting edge technologies in japan, first time to learn about MRCTs, and to make friends with colleagues from diiferent countries." Dr Borimas Hanboonkunupakarn, Mahidol University, Thailand, MRCT STP 2019

 

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“All things are informative and interesting for me. All participants are competent and have much enthusiasm. I was so impressed by comprehensive medical action in Japan. I hope members to keep in touch with each other from now. Thank you!” Dr. Debby Intan Permatasari, RSPI Prof. Sulianti Saroso Hospital, Indonesia, SSP 2016

 

“Useful and effective. Hope that there would be more programs like this to further develop new cooperation chances and understanding about the circumstances of medicine of the both sides: Japan and Vietnam.” Dr. Ly Na Dau, Cho Ray Hospital, Vietnam, SSP 2016


SYMPOSIUM

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2nd Symposium "Setting up preclinical and clinical trial in resource-limited contexts: challenges and current state"