AVAREF Guides and Tool Development

AVAREF has developed a variety of technical guidelines and regulatory tools to facilitate the review of clinical trial applications and the monitoring of clinical trials on the continent. These guidelines and tools have been adopted by AVAREF’s Steering Committee and endorsed by the AVAREF Assembly, composed of all heads of agencies and chairpersons of national ethics committees or their representatives. The process by which AVAREF creates and promotes its guidelines and tools is outlined below.

Process of Creation and Adoption

The technical working group members review existing documents used by African NRAs and international NRAs and develop harmonized guidelines and regulatory documents by reviewing other guidelines used in other continents as well.  For example, the Good Clinical Trial (GCP) Inspection Guide was developed by the technical working group by reviewing GCP inspection guidelines and inspection checklist of NRAs in member states and working closely with technical partners. After thorough review by the technical working group and SC members, the guide was officially developed to be implemented in member states. The working groups under different RECs (Regional Economy Communities) also review the draft guide and made necessary changes for official adoption.

The creation and use of these tools exemplify the shift to standardized clinical trial applications and assessments, as well as ongoing harmonization initiatives on the continent. These advances will ultimately lead to shorter product development timelines.

These regulatory tools were unanimously adopted by the AVAREF Assembly in Victoria Falls, Zimbabwe, in October 2019. All 55 African Member States are encouraged to incorporate these tools into their evaluations of clinical trial applications, including during the current COVID-19 pandemic.