DATA MANAGEMENT TECHNOLOGY &
evolve, so do people and processes inside organisations. These may provide huge value in terms of their individual functions, but collectively they create a system that is resistant to change. The complexity does not end there. All aspects of clinical research cannot be conducted by a single organisation. A highly complex ecosystem of players has evolved in the clinical research landscape, including life sciences companies, healthcare providers and payers, academic institutions, journals, research non-profits, patient advocacy groups, industry regulators, CROs and software vendors, to name just a few. Again, each one of these parties brings significant value, but taken together they represent a set of processes, methodologies and cultures that are very difficult to disrupt.
“If we can address these challenges of technical, organisational and ecosystem debt, our industry and the patients it serves can finally start seeing the benefits of the technology revolution.”
If we are going to disrupt this ecosystem, we must define a problem that is directly felt by the largest part of the ecosystem possible and then align incentives to ensure that the ecosystem as
46 | Outsourcing in Clinical Trials Handbook
a whole addresses it. Unfortunately for much of the recent past, the problems of clinical research have been predominantly framed from the perspective of one player (the sponsor) and have dealt mainly with costs. Eroom’s Law is usually described in this way, citing a halving of research and development efficiency every nine years, and resulting in a 100-fold increase in the cost of getting a drug since 1950. Alternatively, the average figure of $2.6bn to bring a new drug to market is widely cited. Aligning an ecosystem around this problem is really difficult. Solve it, and you will leave some parts of the ecosystem unaffected and may negatively affect other parts of it. A simple reframing of the problem around the patient and around time, rather than cost, can make a huge difference. Solving the problem of ‘patients are delayed access to the best available treatments’ gets sponsors to renew faster, allows regulators to act in the best interests of patients and benefits patients directly through better health outcomes. CROs can get behind the same mission through financial incentives to deliver greater efficiencies. If we can address these challenges of technical,
organisational and ecosystem debt, our industry and the patients it serves can finally start seeing the benefits of the technology revolution. The technology we need is here, all that remains is our ability to adopt it and benefit from it. ●
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