GUIDELINES FOR GOOD PRACTICE IN THE CONDUCT OF CLINICAL TRIALS IN HUMAN PARTICIPANTS IN SOUTH AFRICA
7. MULTI-CENTRED STUDIES
A multi-centred study is a study conducted simultaneously by several investigators at different centres, with standardised methods and protocol.
In South Africa, multi-centred trials must adhere to all national regulatory requirements.
Moreover, the design of the multi-centre trial must ensure that local realities are considered and well integrated into the design of the study. In particular the following must be addressed within the protocol:
- Inclusion and exclusion criteria must be appropriate for local realities
- Informed consent procedure must be tailored to local conditions
- Study design differences between South Africa site/s and other sites must be fully explained
- Awareness of the need to ensure that study extrapolations and conclusions are relevant to the South African context
To ensure these aspects and others are addressed within the protocol and that the proposed research is ethical, local investigators must always critically evaluate the protocol before submission to the regulatory authority.
The person responsible for the overall clinical care of the patient should be closely concerned with or informed of the running of the research project. This is to avoid any uncertainty on the part of others in the clinical team, if there should seem to be conflict between the apparent demands of the research protocol on the one hand and the interests of the individual patients on the other. At all times the patient’s interests take precedence.
Except for in exceptional circumstances (with the permission of the Department of Health, DOH) the DOH would like to strengthen national institutions in conducting clinical trial research. Within this understanding, the principal investigator or overall project manager should be a South African based scientist. This condition also applies to collaborating projects with international research groups and multi-country studies. In the case of international (multi-centre) trials, there will be a requirement that a reasonable proportion of significant project team members (managers and technical experts) be South African based scientists.
Given these complexities, an independent steering committee should be established within country to ensure that the study is planned according to acceptable scientific and ethical standards. This committee must have access to study finding(s) and any adverse events. The roles and responsibilities of this steering committee should be clearly stated within the study protocol.
The steering committee and the sponsor should ensure that:13
- All investigators conduct the trial in strict compliance with the protocol agreed to by the sponsor and, if required, by the regulatory authority(ies), and given approval/favourable opinion by the ethics committee.
- The CRFs are designed to capture the required data at all multi-centre trial sites.
- The responsibilities of coordinating investigator(s) and the other participating investigators are documented prior to the start of the trial.
- All investigators are given instructions on following the protocol, on complying with a uniform set of standards for the assessment of clinical and laboratory findings, and on completing the CRFs.
- Communication between investigators is facilitated.
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Footnotes
[13] ICH Harmonised Tripartite Guideline. Guidelines for Good Clinical Practice. Recommended for Adoption at Step 4 of the ICH Process on 1 May 1996 by the ICH Steering Committee