Report On The Introductory Training On Clinical Trial Design For Investigational Medical Devices.
This training was held on Monday 14th March, 2022 at Golden Tulip, Canaan Hotel Kampala. The training was organised by the Centre for Innovation, design and Translational excellence under the CERMU-CITE project. The training attracted 30 physical and about 25 online participants. There were presenters from the University of Edinburgh, Herriot Watt University and Makerere University Biomedical Engineering Unit.
The program started at 9am with welcome remarks and introductions made by the Principal Investigator of the CERMU-CITE project, Dr. Robert Ssekitoleko. He gave a brief overview of the course and a breakdown of what would be covered along the day. He also explained the activities participants would be taken through. Following the introduction, Ms. Sharon Tuck, a statistician from the University of Edinburgh coordinated the presentations from Edinburgh, as Dr. Robert steered the program.
The first session began with Prof. Marc Demulliez who delivered a presentation on medical devices and their regulation. He discussed the definition of medical devices, their intended use, their regulation, essential requirements, clinical investigation and evaluation. Prof. Steff and Ms. Sharon then delivered a presentation on background to clinical trials, their importance and how to design them. The session was concluded with a question-and-answer session facilitated by Dr. Robert and Prof. Marc.
The mid-morning session centred on the process of studying and marketing medical devices. Prof. Marc discussed protocol development for clinical trials and the Brunel Model. Prof. John Norrie gave a presentation on the classification of medical device trials and regulation of medical devices in the UK. He discussed some procedures followed and highlighted the differences between trials for medical devices and drugs. Dr. Robert then delivered a presentation on regulation of medical devices in Uganda, highlighting some of the preliminary findings from the data collection exercise he was conducting to study this topic. He also discussed the process of getting a deice adopted into the healthcare system, highlighting some devices innovated in Uganda, that had made significant progress on that. He discussed the importance of data security and public patient involvement. The session ended with a question-and-answer session facilitated by the presenters.
The afternoon session was set as an interactive workshop on designing a device trial. Facilitated by Dr. Robert, this session had participants split into three groups, each allocated a case study to devise a project plan for future development of the device, using the knowledge and information that had been shared in the morning sessions. After half an hour of discussions, each group was given time to present their project plan and the facilitators/presenters commented on the plans of each team. The session ended with a brief roundup and question-and-answer session.
Following the afternoon session, Dr. Robert thanked the presenters for their involvement, and the participants for their attendance. After delivering his closing remarks, he ended the training at 5pm.
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