CASMI’s mission is to help make the medical innovation process more efficient and sustainable, recognising that there is much unmet clinical need to address and the development and adoption of new drug solutions are slow and costly. Since inception we have seen the medical innovation process as a circular one (Figure 1), which starts and ends with the patient – from recognising the patient’s clinical challenge that needs to be addressed to ensuring that the patient has access to and is supported in adhering to the resultant treatment as appropriate.
Conventionally academic effort has been principally focused on the biomedical quadrants of the medical innovation circle – for example formulating the research question, conducting discovery science that may lead to new insights into disease mechanisms, the identification of potential drug targets and proof of principle, and of course clinical trials of resultant products, often in conjunction with industry. These essential contributions, at which incidentally the UK is very good, help ‘push’ new products towards the market place. It is critically important that such work is done as efficiently as possible with greater attention paid to the forging constructive alliances between academia and industry which clearly recognise the contribution made by both parties, and earlier, more definitive proof of concept studies to limit late stage attrition. But CASMI has recognised that greater attention also needs to be paid to what might be referred to as the ‘pull’ factors – the reception, purchasing, adoption and diffusion, and ultimately taking of and adherence to new medical solutions. CASMI’s Medical Innovation Academic Consortium (MIAC) has a wide range of research interests in this area best summarised as questions relating to the perception of risk and value at the level of the individual (citizen, patient and prescriber), system (e.g. the NHS), and the regulator.
Figure 1 – The Innovation Cycle
One important facet of this ‘pull’ agenda is how we all judge scientific evidence on the potential benefits and harms of new medicines. Triggered by concerns about the suggestion that treatment thresholds for the use of statins to prevent cardiovascular disease should be lowered, the Academy of Medical Sciences has been involved over the last eighteen months in trying to make sense of this complex agenda and come up with recommendations that improve decision making and the confidence of those making decisions in the future. Several CASMI Fellows have played important parts in the various work streams which have involved i) consideration of the methods used to generate evidence and their relative value and limitations, ii) how we might enhance trust in the resultant evidence, and how it is best communicated to both healthcare practitioners and of course patients – all underpinned by extensive public engagement including surveys and deliberative dialogue. It has been my role to chair the Oversight Group that will attempt to bring this all together, easily the most complex exercise of its type I have been involved in! We plan to publish in the Spring of 2017 and one of the outputs that I hope it will stimulate is the generation of a research agenda that reflects important ‘known unknowns’ and the commitment of funders to support efforts to address it.
It has always struck me that if the focus of academia remains firmly centred on ‘push’, the early stages of development of a new medicine and resultant trials, we are only contributing to half the job. Our contribution needs to be holistic if the efficiency and sustainability of the innovation cycle is to be optimised, drawing on expertise from well beyond the conventional biomedical fold. The late social historian Roy Porter at the end of his treatise on medical advances over the centuries concluded: ‘Medicine has led to inflated expectations which the public eagerly swallowed. Yet as those expectations were unlimited they were unfillable: Medicine will have to redefine its limits even as it extends its capacities.’ To defy that somewhat gloomy prediction and reap the full rewards of modern science for patient benefit the academic community will have to help resolve the many factors that impact on the take up of new medicines by society – the ‘pull’ to complement the ‘push’.
– John Tooke