Workshop on regulatory procedures for clinical evaluation of vaccines, Addis Ababa, Ethiopia, 21-23 September 2005
- Assess legal framework in participating countries with regards to the NRA's mandate to authorize, monitor and terminate clinical trials and importation of clinical batches
- To develop procedures for authorization and monitoring of CTs, and importation of clinical batches
- Integration of activities to the IDP
- Assess the consensus on a regional approach for evaluation of vaccines.
The workshop was attended by NRA representatives, responsible for the regulation of clinical trials, from the following countries: South Africa, Senegal, Mali, Ghana, Gambia, Tanzania, Uganda, Kenya, Ethiopia, Nigeria, Cameroon, Botswana, Zambia. These countries are target for clinical trials of HIV and MenA conjugate vaccines.
The current status on the existence and effectiveness of a legal framework was presented by the NRA representatives and discussed. In many cases, although the legal basis is in place, the NRA does not exert the authority to regulate clinical trials, either because there is another institution (like Scientific Councils) who is issuing the clearance for clinical trials, or because the clearance is given by the National Research Council who is performing the clinical trials and has at the same time an institutional Ethics Committee. This leads to conflict of interest situations, and a lack of communication to the NRA regarding the clinical trials in the country. The NRA representatives understood the critical importance of their involvement in the regulation of clinical trials as well as the difference between the ethical and regulatory review of clinical trial applications.
There is a need for strengthening of regulatory capacity first to develop the procedures and then to perform the review of clinical trial applications and monitor clinical trials. The participants worked on the development of guidelines for submissions of applications for clinical trial authorizations, for importation and release of clinical batches, and for review of clinical trial applications. These outlines were prepared using other existing guidelines from various regulatory agencies that were provided and based on the wealth of existing expertise among the participants. The three documents will be processed to put them in the format of regulatory directives and prepare a "model regulatory package" that countries can use as the basis for use at the national level.
Discussions on regulatory monitoring of clinical trials concluded that NRAs need training in GCP and other relevant issues. Therefore a plan of activities including training and joint monitoring will be prepared by WHO to help countries during the upcoming clinical trials and to be prepared for the development of national procedures.
The procedures developed will set the basis to process the clinical trial applications of the upcoming CTs of Mening A vaccine in 2006 and for HIV CTS (To be planned with IVR/HVI). Furthermore all procedures and guidelines prepared and all capacity building activities will be applicable to the regulation of other new vaccines in the future.
It was agreed that the joint review of CT for Mening A vaccine and monitoring of the CTS are an excellent opportunity to build national and regional capacity and that the joint activities are consistent with the accepted idea of NRAs working together, leading to the establishment of a regional network of regulators.
For those countries that had attended the NRA Planning Workshops the importance of the endorsement of the Institutional Development Plan (IDP) by their governments was discussed and they committed to actively follow up on the process. They have also adjusted the IDP according to the newly acquired knowledge.