Maintaining a High-Quality Clinical & Laboratory Network
COMBACTE provides trainings in Good Clinical Practice (GCP) for clinical and laboratory investigators participating in COMBACTE trials. Since 2014, 1025 investigators have been trained. The online training has been followed by 560 participants and 465 participants joined one or more of the face-to-face trainings across Europe.
IMPORTANCE OF GCP TRAININGS
One of the objectives of COMBACTE-NET’s clinical and laboratory networks, CLIN-Net and LAB-Net, is to maintain a European network of clinical investigation sites that performs clinical trials compliant to the ICH-GCP guidelines. Training researchers is important for the quality of clinical research done in COMBACTE trials and for the trials in which the COMBACTE network is being used.
To date COMBACTE-NET conducted 17 face-to-face GCP trainings in Switzerland, Spain, Serbia, Greece, Hungary, Bulgaria, Montenegro for investigators in the Balkan, Italy, Portugal, Romania, Czech Republic for investigators in Central Europe and Latvia for investigators in the Baltic area. including local researchers and researchers. The last training was held in 2019, due to the COVID-19 pandemic. Despite this COMBACTE continues to offer online GCP trainings.
COLLABORATING WITH EXPERTS
A face-to-face training offers practical guidance on optimizing the difficult recruitment of patients. It consists of plenary sessions and interactive discussions on essential regulations. During the face-to-face trainings, the participants do not only learn about GCP but the trainers make sure the investigators are able to learn how to organize, manage and run the clinical trials more efficiently. Someone who participates in a GCP training is afterwards not only an efficient clinical investigator, but also gets a good basic practical understanding of what needs to be done, which processes and resources they have to implement in practical terms, how they can structure their own work and which training their team members need.
The trainings are organized in collaboration with the European Forum for Good Clinical Practice (EFGCP). Dr. Ingrid Klingmann, founding member and Chairman of the Board of EFGCP, shared her expertise with the researchers on the challenges for investigators in clinical trials. According to Dr. Klingmann training researchers is pivotal for good clinical research:
“Especially in countries where multi-resistant infections are particularly frequent, many physicians are not prepared to perform these very demanding studies in their environment. The biggest challenge is to integrate these additional activities and the paperwork into their daily hectic routine. It’s really difficult for them to enroll patients into the studies because they have an infrastructure for care but not for clinical trials and they don’t know how to optimally utilize their resources for clinical trial performance. The other big problem is the need for very close collaboration with staff in the hospital laboratory that is also familiar with the study requirements.
TEAMWORK IS KEY
One of the frequent bottlenecks in clinical trials is lack of good collaboration between local study teams. In the face-to-face trainings clinical and laboratory investigators with different specialties are being put together. The participants work in groups during interactive sessions and discuss how to organize the protocol-related requirements in the most optimal way to improve the teamwork.
Most participants found the training very useful, as it offers practical recommendations how clinical trial performance could be improved. One of the participants in Lisbon stated after the training that “the COMBACTE GCP course was much more interesting and exciting than I originally expected. It had a perfect plan and great speakers. If given the chance I would recommend it to other colleagues.”
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