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The fifth, often controversial consideration is context and relevance, which amounts in practice to translational purpose. It is possible in a particular culture to consider clinical science to be part of the ‘blue sky’ search for knowledge which sometimes ‘spins off’ benefits as serendipitous outcomes. An alternative culture seeks out topics that are obviously related to major health problems, and addresses them according to deliberate project designs, usually with carefully assembled multidisciplinary teams, to maximise the probability of beneficial public outcomes, and to underpin the attainment of those benefits in evidence-based ways. A balance between these polar opposites must be found in a resource-constrained system.
An overridingly important ‘cultural’ issue that directly affects the sector is motivation in respect of private as opposed to public benefit. Compared with a systemic prevalence of public-sector clinical research projects which are initiated and funded only in support of profits by pharmaceutical companies, and/or one where researchers are mainly hunting for personal glory and/or tangible benefits such as salary supplements, conference travel and other perks, the widespread existence of an ethos of public service and public benefit undoubtedly represents a desirable and necessary ‘cultural’ polarisation.
The last, but by no means least, of the dominant issues in a national culture supporting good clinical research concerns the imperative to protect and develop new discoveries in an efficient and effective intellectual property rights regimen that can bring benefits to both the health care practice and economic development of the country. This implies careful construction of partnerships, adequate funding of patent registration applications, and a tax system that incentivises innovation. It is a mind set as much as a regulatory approach.
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intensively motivated for funding and support because of their relevance to human diseases), is not closely linked to the domain of clinical studies, organisationally or functionally. Clinical specialities, and in some cases even sub-specialities, have tended to withdraw into individual, small, internally interactive domains with their own national societies, conferences and periodicals or newsletters. Their better-quality publications have over- whelmingly appeared in international speciality journals indexed in the Thomson Reuters ISI Web of Science (ISI) system, something which in itself is a laudable aim and part of the national policy of ‘internationalising’ South African research. Unfortunately, it makes much of this good work effectively invisible to South African colleagues in other specialities, or to the non- clinical, laboratory researchers in the same or related fields (see Chapter 6 for details).
There is thus a distinct lack of cross-fertilisation, peer consultation and functional community in the local clinical research domain, which minimises the value of animal or in vitro models to the understanding of human diseases, and results in distrust and lack of communication between those who perform clinical studies and those who work reductionistically in laboratories. As the latter often have significantly more time to devote to their research activity, and can more readily assemble teams of associate scientists, graduate students and postdoctoral fellows, a sense of inferiority on the part of clinical researchers readily develops, which often leads to resentful closure of the few communication channels that do exist.
Ultimately, the deeper meaning of ‘the proper study of humankind is humans themselves’ is not compatible with a real or perceived position of clinical research as intellectually or methodologically second rate, compared with laboratory studies.
The specific training and mentoring required to capacitate researchers who are fully equipped to carry out studies on humans is mostly inadequate compared with that for laboratory investigators. This may or may not be due to significant extra costs and a lack of willing trainees, but it may also be symptomatic of a reluctance to embrace the principle of human studies
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as core to human health. What is visible and highly problematic is a virtual absence of ‘MD: PhD’ programmes at the health science faculties, the lack of facilitation of participation of professional graduates in post-basic research honours and master’s degree programmes through appropriate bursaries, career structures and organisational arrangements, and the paucity of centres of excellence and research chairs in this field (see below in this chapter and elsewhere in this report).
Research centres and institutions in developed countries have an enormous depth of human and other resources, augmented by easy communication and the willingness to put research at the top of priority lists. The teaching and service loads of clinical academics are very much lower than is the case for their counterparts in developing countries such as South Africa.
Establishing and maintaining a critical mass of actively researching clinicians is accordingly extremely difficult in our situation, with emigration to greener fields in the North an ever-present temptation. It is thus understandable that the managers of health science faculties and the budget-challenged providers of health services have drifted to a model where the outcomes of clinical research performed elsewhere are incorporated into teaching and practice locally as far as that is possible, and truly investigative clinical research is
‘given up’ as too costly, too difficult and too frustrating. Sponsored ‘me too’
clinical trials and low-level ‘action research’ in pressurised clinical practice is often all that remains, presented to the world and society as relevant activity and appropriate to local conditions. But this kind of clinical research is not what is needed to promote best-possible health care and the most effective training and education of young clinicians, nor is it anything more than the acceptance of a kind of permanent ‘colonial status’ vis-à-vis the developed countries of the North.
It is symptomatic of the ‘giving up’ culture described above in relation to clinical research that the kinds of opportunities recently created for talented researchers in other fields by the Department of Science and Technology (DST) and the National Research Foundation (NRF) have not targeted the area of clinical research more than tangentially. The schemes for nationally selected
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research chairs and centres of excellence, equipment catch-up programmes, and a national ‘PhD project’ have been enthusiastically implemented in non-clinical areas, and the MRC has been unable or unwilling to resolve the long-standing issue of its relationship to the strategic efforts of the DST (and cabinet) to strengthen R&D in the country. The fact is that no programme exists that is designed to boost high-quality activity in clinical research as one of the country’s most important intellectual spheres, specifically one which also promotes better designed and delivered health care, enhances foreign direct investment, and has been a traditional strength in the national system of innovation.
Another demonstration of the ‘giving up’ culture pervading clinical research is the inexplicable neglect of an issue that has for years been the ‘elephant in the room’ in terms of the organisational/operational context of the discipline. With academic hospitals regarding research activity as outside their mandate, mission and brief, with the National Health Laboratory Service (NHLS) considering clinical research activity as a market like any other, and with the MRC intimating to clinical researchers that because of funding limitations it is unable to fund patient-related costs of otherwise supported projects, a huge gap appeared that no policy-making has addressed and no stakeholder or participant has clearly and publicly recognised and decried.
The pharmaceutical industry has simply had to fill that gap by default (see other sections of this report). The public service ethos of this research domain has quietly declined, and curiosity-driven investigation has diminished.
The above situation is not compatible with the previously listed six core components of a productive, self-perpetuating national culture of high- quality clinical research. These components are inter-dependent, and operationalising them will require concerted and cooperative actions by many of the stakeholders in central and provincial government. The revitalisation and repositioning of clinical research in South Africa can help to develop new or more effective treatments for the health problems affecting our population. Creating a solid and efficient infrastructure for clinical research in South Africa can help to attract foreign direct investment for local economic
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development, and developing and nurturing local clinical researchers can help to grow our human capital and reposition South Africa as a knowledge- based economy.