188

1.1.1 Number of Short-Term Training Courses Held

1.1.1.12 Clinical Trial Training

- -

1.1.2 % of Researchers Participating in Short-Term Training Courses

 

 

Clinical Trial Training

Training

1. To build understanding of theoretical and practical concepts of a good clinical trial; 2. To emphasize consideration of the ethical aspects from Clinical Trials 3. To describe identification of the steps on designing a Clinical Trial "

Traditional (Face to Face)

16

Bandung

Magnolia 1 And 2 Meeting Room, Courtyard Hotel, Bandung

-

 

 

 

5040000

56000000

21000000

None

 

 

 

 

 

 

This activity is a pilot project from UNPAD. Currently, there is no training available to provide an overall description of Clinical Trial study, in Indonesia. This training is the first to be conducted in Unpad and Indonesia. In order to prepare for this training, we involved one of the most regarded scholar in Clinical trial in Indonesia, Jarir At Thobari, MD, DPharm, PhD. The design and content of the training was discussed together with Dr. Jarir. We decided to use three approaches : a classroom approach, critical appraisal of a clinical trial article, and group work to design clinical trial. The resource person for this training involved Unpad faculty members with extensive experience in leading a clinical trial research (Prof. Cissy, Prof. Rovina, Prof. Budi, Prof. Kusnandi, and Dr. Eddy. ), data analysis (Dr. Dwi Agustian, dr. Kurnia), ethic in research (Dr. Meita) and critical appraisal (Dr. Yulia). In addition, Dr. Jarir was asked to provide an introductory lecture on the phases of Clinical Trial. However, because during the training Dr. Jarir will be attending a conference abroad, he agreed to make a video lecture for us. All of the resource persons were enthusiastic about conducting this training, as this is the pilot project. In the future, if successfull, this training will be organized the Ethical Committee Board, Faculty of Medicine UNPAD. The training was designed for 2 days. Consisting of lecture and acivitiy work. At the end of the session, participants were asked to present their desigin of a phase II clinical Trial. "

Overall the activity was a success, considering the participants gave good review and found the topics useful. The training was conducted according to schedule. Eleven Resource Persons are from UNPAD, with material coverage as below: 1. Introduction to Clinical Trial 2. Phases in Clinical Trial : Phase I-IV 3. Characteristics of Phase I-II Clinical Trial 4. Characteristics of Phase III-IV Clinical Trial 5. Ethical issue and Regulation of Clinical Trial in Indonesia 6. Design of RCT: randomisation, blinding, trial size 7. Ethical conduct: participant consent, data monitoring and when to stop early 8. Introduction to statistical methods for both design and analysis 9. Clinical trials in practice 10. Structure of clinical trial report 11. Practical experience in development of a clinical trial protocol. (Participants will work in small groups to develop and present trial protocols. ) The method will be a combination of the following: • Lecture • Discussion • Group Activity • Article appraisal From total 29 participants, 17 were CCR-ARI Scholars (10 UNPAD; 2 from UNRAM, UNSYIAH and UNPATTI; 1 from ULM) "

The participants had a difficult time during the article critical appraisal activity. Most considered this acitivity very challenging as most were new in reading a clinical trial article, while critical appraisal is an approach to review and ciritize the article on whether or not the quality is sufficient. Participants suggested that this acitivity to be done slowly, providing adequate time for participants to read and understand the article before doing a critical appraisal.

Overall the training was well received by both participants and resource person. However, its best to be conducted in three days so there will be enough time to go into detail in each topic, particularly on sampling, randomization, and data analysis.

This training is to support the imunogenicity clinical trial that is being done by CCR-ARI.

N/A

N/A

We did not conduct the pre- and post-test within this training. However, to assess the abilities of the participants before and after the training, we asked the participant to recall information in the morning of the second day. The participant should recall the information that given on the first day. We expected that we can evaluate the participants understanding from the previous lectures. At the end of the activity, we performed group hands-on activities. The facilitators give a specific case to the participant and ask them to design a clinical trial. Participants discuss and formulate a research plan. The participants filled out the form / template and presented in front of the class at the final session. "

26

27

David Tri, Winda Aurelia, Fara Tari, Lina Fita, Fajar Eri, Yolanda Aqilla, Yudi Xavier, Intan Eira, Yudi Andi, Novi Akbar, Livia Windi, Erna Laras, Putri Indira, Joni Junaidi, Amanda Xena, Emilia Raya, Bagus Farrel, Anita Shaliha, Dinda Adinda, Agatha Linda, Hafiz Zulyanto, Abhiram Sugiarto, Bayu Tristan, Riana Risa, Balqis Lina, Dinda Shafira, Mega Putri, Putri Rania, Zulmi Fadly, Aulia Susana, Satria Omar, Nizar Oki, Rima Ira, Syamsul Slamet, Gita Gabriella, Maulana Haryadi, Fitria Ghania, Fikri Fauzi, Aurelia Fita, Ayunda Rafa, Sopian Oki, Devi Eka, Fajar Rangga, Robi Naufal, Risa Windi, Pratama Yasin, Zaki Opan, Olivia Intan, Dafa Zulman, Rafli Zaky