International Consortium for Trials of Chemotherapeutic Agents in Tuberculosis (INTERTB)
CAPACITY STRENGTHENING IN OPERATIONS RESEARCH
The objective of capacity strengthening not only entails training in the conduct of randomised clinical trials and of data management. It requires also quality assurance of laboratories and expanding the ethical principles in carrying out trials using human subjects. This capacity will be developed and sustained in several ways. This capacity would have to be strengthened so that Participating centres are better able to conduct trials of chemotherapeutic agents. Such capacity strengthening would broadly fall within the following bounds :
3.1 Conduct of clinical trials
We believe that participation in the trials itself will strengthen the capacity of the participating centres to perform internationally significant operations research. By following the protocol, in every detail, collaborating institutions in low income countries will develop their capacity, in terms of designing and carrying out studies relevant to their own situations. They will acquire knowledge as to how to conduct randomised clinical trials.
3.2 Good clinical practice (GCP)
The International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use has defined Good Clinical Practice (GCP) as an international ethical and scientific quality standard for designing, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical data are credible.
In order to meet international standards on experiments in human subjects and Good Clinical Practice, there is a need to develop and enlarge the local ethical guidelines and strengthen the local institutional review boards to evaluate and monitor such trials.
The system of local ethics review clearly needs to be standardised, as far as it is possible to do so, in order to meet international guidelines for experiments conducted on human subjects.
The International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use has also published guidelines for the obtaining and documenting of the informed consent procedure.
Episodic training through workshops will be given to all those involved in conducting clinical trials.
3.3 Good laboratory practice (GLP)
'Good Laboratory Practise' (GLP) is a quality management system for the organisational process and the conditions under which laboratory studies during clinical trials are planned, performed, recorded, monitored and archived. GLP compliance is a necessary requirement of laboratories undertaking clinical trials, but this is a dynamic process requiring reviewing and updating of systems, surveillance and auditing.
3.4 Workshops and Seminars
Investigators from the participating centres as well as other personnel of National Tuberculosis Programmes would be invited to attend workshops and seminars. Since we consider that, one of the most important things a programme can do is evaluate the efficacy of its interventions or of proposed new interventions, the participants will consist of staff already taking part in the clinical trials network and thus in settings that require the application of such skills.
The process of training in operations research, and of capacity strengthening to do such research, will require a sustained effort.