Situating Efficacy: Biomedicine, Interdisciplinarity, and the Politics of Intervention

Introduction :

In this symposium we ask what an interdisciplinary approach might offer to redressing the challenges now posed in the translation of ‘efficacy’ to ‘effectiveness,’ as the distinction is upheld in health and medical research. Bringing together participants from the natural and social sciences, speculative design, international policy and programming, and non-government organization implementers, we will consider the potentials and limitations of experimenting with alternative forms of interdisciplinary interventions in complex naturalcultural problems. 

A symposium on the distinction between efficacy and effectiveness in HIV health and medical research: Is it feasible to conceive of ‘situated efficacy’? Although the randomized control trial (RCT) is considered the gold standard for evidence-based research in medicine, its findings of biomedical ‘efficacy’ under isolated test conditions stand apart from what affects the successful implementation and take up of the intervention, that is, ‘effectiveness’ in real world conditions. In this symposium we consider the challenges that emerge through this distinction and what an interdisciplinary approach might offer to redressing the challenges now posed in the translation of ‘efficacy’ to ‘effectiveness’. Broadly speaking, assessment for safety and efficacy by the RCT as a clinical method in medicine involves the determining of statistical power for establishing efficacy, recruitment in accordance with the required statistical power and monitoring procedures to guard against contamination by potential co-existing medical and/or external life factors. In practice, this involves restricting research subject participation to those who express preparedness to adhere to the procedural requirements of the trial, sometimes including self-reporting on life circumstances as well as excluding those who’s measured state of health does not confirm to the ‘optimal’ conditions for achieving efficacy. The aim of the test of ‘efficacy’ is thus to be able to lay claims about the effects of a biomedical intervention in isolation from any other so-called ‘confounding‘ variables. Once shown to be statistically efficacious (an estimate of considerable variability in actuality – see Neyland, 2011), an intervention is then considered ready for effectiveness testing in ‘real world’ conditions. It is at this stage that other sciences such as anthropology, sociology, public health as well as those responsible for implementation in government and/or non-government organisations are called upon. That is to say, it is at this stage that social, ethical, legal and economic co-existing factors critical to the effectiveness of the intervention in the ‘real world,’ come into consideration. Not surprisingly, many efficacious interventions fail to deliver their desired outcomes due to such co-existing factors (Glasgow et al, 2003). In short, the distinction between ‘efficacy’ and ‘effectiveness’ upon which RCTs rest, makes available a specific centre-periphery mode of multidisciplinarity: biomedical researchers deal with the central question of ‘efficacy,’ while social researchers, policy makers and implementers (in public and non-government organisations) engage with contextual issues and practices of remediation rendered peripheral to the intrinsic success or failure of an intervention itself. The broad aim of the symposium is to facilitate an interdisciplinary exchange on the implications of efficacy testing by RCTs for ‘real world’ implementation, not to mention trial ‘failure’ when a statistical determination of ‘efficacy’ is not achieved. A more specific secondary aim is to provide a forum in which to ‘test’ a concept of ‘situated efficacy’ (now in development with funding from the British Academy) and its potential as a basis for novel modes of interdisciplinary collaboration. At the centre of the development of a concept of ‘situated efficacy’ is an attempt to rethink the effects of biomedical interventions such that any clear-cut distinction between the controlled environment of the RCT (which the testing of conventional ‘efficacy’ requires) and the ‘real world‘ (which concerns the question of ‘effectiveness’) is not presupposed but rather problematised. More concretely, then, the main focus of discussion will be the recent findings of RCTs for HIV biomedical prevention with some reference to those for Malaria prevention and Tuberculosis cure. The challenge of translating ‘efficacy’ to ‘effectiveness’ is now especially pertinent to the HIV field as biomedical prevention technologies show promise based on RCT efficacy testing, namely daily oral dosing pre-exposure prophylaxis (PrEP), topical microbicide preparations for vaginal and anal use and, most preferred, a vaccine against HIV infection. Key questions posed by the forum will be: What is efficacy? In what ways does the process of achieving a claim of efficacy provide a constraint that guides policy and implementation? In what ways do such processes, in themselves, act as a constraint on experiences of the ‘real world’ as complex and dynamic? Are there economic and legal issues arising from efficacy testing that are excluded by the prioritizing of a quantified account of a new intervention? Can demonstration studies provide an alternative or follow up to efficacy studies? What constitutes a demonstration study for the purposes of enabling effectiveness? What can we do with the phenomena externalized by the method of the RCT, including that offered by research subjects who do not adhere to trial requirements despite their otherwise apparent participation? What is effectiveness from the perspective of the implementer? Should implementation be understood as a follow on to the RCT method or as an important informant of the RCT method? Might there be an alternative to the current distinction between the RCT and ‘real world’ implementation? Can a concept of ‘situated efficacy’ serve as a model for interdisciplinarity, possibly by-passing the problematic distinction of efficacy/effectiveness? Participants will be drawn from the natural and social sciences, speculative design, international policy and programming, non-government organization implementers. Twelve of the participants will act as speakers and will be asked to circulate papers in response to designated questions from the above list. Prior to the symposium, the organisers Rosengarten and Savransky will also circulate a proposal for ‘situated efficacy’ prepared in response to the hypothesis that the notion of ‘efficacy’ as understood in RCTs constitutes not only a test but also creates a disciplinary boundary that limits modes of collaboration and engagement.

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