Ensuring Good Clinical Practice – Three VaccTrain partner authorities are strengthening their inspection skills
Good Clinical Practice (GCP) inspection is an important regulatory mechanism to ensure the safety of participants involved in clinical trials. Therefore, the VaccTrain 2.0 team provides the necessary knowledge and structures to regulators of Liberia, The Gambia and Sierra Leone. As a highlight, all partners were able to put their knowledge into practice during a real inspection in Liberia.
As part of its official mandate the Liberia Medicines & Health Products Regulatory Authority (LMHRA), conducted a GCP Joint inspection at one of the country’s most active clinical trial site where a new candidate vaccine is being assessed. For this inspection, the LMHRA invited the VaccTrain 2.0 team to serve as observer while two partner national regulatory authorities (NRAs) of The Gambia and Sierra Leone to participate. It was an excellent opportunity given by LMHRA to review its regulatory processes around inspections, to strengthen them, to apply them in practice – and to share this experience with partner authorities. The Inspection took place in Liberia from September 5th to 7th, 2023.
You learn inspections by inspecting
At the start of GHPP Phase II in 2023, all three partner countries in the VaccTrain project had given high priority to capacity building in the regulatory implementation of Good Clinical Practice inspections in order to be able to monitor clinical trials more effectively. To this end, the VaccTrain team is working with its partners to review existing technical structures such as guidelines, checklists, standard operating procedures (SOPs) and forms, and to develop and harmonise them with the international standards of the `International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use´ and AVAREF’s Africa-wide `Guide for the Inspection of Clinical Trials´. With support of the VaccTrain team, the LMHRA put the revised guidelines into practice during an inspection in Liberia. Dr. Juwe D. Kercula, Head of the Clinical Trials Unit at the LMHRA, says: “The joint GCP inspection afforded us the opportunity to share our expertise in conducting a GCP inspection with our observers, who provided us technical support during the exercise.” Dr. Victoria Olaiya, who took part in the inspection together with Dr. Ulysse Ateba Ngoa for the VaccTrain 2.0 team, added: “The most effective way to learn how to inspect is to inspect. By this joint GCP inspection the regulators were able to improve their regulatory skills.” With the joint participation of three partner countries, everyone benefited from this intensive exercise and from the exchange among themselves. It is important to build confidence in the regulatory activities of neighboring authorities and to intensify cooperation for the benefit of patients.
Follow up on knowledge gained
In a follow-up workshop in Kigali in mid-November, lessons learnt of the first joint GCP inspection in Liberia were discussed with the three partner NRAs and further training on practical aspects was provided. Dr. Kercula: “The Kigali workshop was very timely as we were able to discuss and address the gaps observed during the conduct of the joint GCP inspection in Liberia.”
Moreover, VaccTrain 2.0 continues to provide input on regulatory and operational GCP inspection tools of the Medicines Control Agency of The Gambia (MCA) and the Pharmacy Board of Sierra Leone (PBSL) to facilitate harmonization with international standards. A second inspection of a clinical trial site with participation of the VaccTrain 2.0 team took place in The Gambia in November 2023. Further practical exercises are planned in 2024 to promote implementation of GCP inspections in routine practice.
Background: Inspections are an effective tool for authorities
In clinical trials, new drugs and vaccines are taken by human participants for the first time. They are subject to strict standards of design, conduct, documentation and evaluation in order to protect the rights and safety of patients and to ensure the quality of the study results. These standards are summarized internationally as Good Clinical Practice (GCP). It is the task of the medicine regulatory authorities, which approve and monitor clinical trials, to ensure that Good Clinical Practice is complied with. One effective instrument is the inspection of trial facilities. In this process, the competent authority can inspect the premises, documentation, equipment and other relevant resources. In a subsequent report, the authority summarizes its observations, classifies deficiencies and risks according to their severity, and depending on the findings – reminds the sponsor/manufacturer to make improvements or initiates action. In the most extreme case, the authority may exclude the site from the clinical trial or stop the entire clinical trial.
Overview of dates of VaccTrain support for GCP inspections:
June-August 2023, Virtual Technical Support on GCP Inspections
5-7 September, 2023, Liberia, Conducting a GCP Inspection
13-15 November 2023, Rwanda, Workshop Follow-up on GCP Inspections
22-24 November 2023, The Gambia, Conducting a GCP Inspection
Links to the international Resources of GCP Inspections:
- The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; E6/Revision 2 https://www.ich.org/page/efficacy-guidelines
- AVAREF Guide for The inspection of Clinical Trials https://www.afro.who.int/sites/default/files/2019-09/8-Avaref_GCP%20inspection%20guide_Sept2019.pdf
