AN AGILE APPROACH
Going agile: how it can improve clinical trials
David Larwood, CEO of Valley Fever Solutions, discusses agile design.
adapt and redesign phases of a project. When it comes to clinical trials, agility can be incorporated into both the design and execution stages in order to refine and improve the process. Incrementally optimising a clinical trial like this increases its efficiency, meaning we can help more patients more quickly.
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Agile design Agile design takes a complex project and breaks it down into relatively small components, fine-tuning each one for the benefit of the overall project. In clinical trials, numerous critical components can be optimised. The clinical endpoint is a measurement of some symptom or reading which is the target outcome of the trial – for example, the trial may aim to reduce the severity of a
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y definition, agility is the ability to move quickly and easily. In project management terms, it means being able to frequently
certain symptom in subjects. This endpoint should be established in the trial design, along with the parameters of the trial and best practice procedures, which should be aligned across all test sites to avoid costly inconsistencies. Operations should be governed by a template protocol, and efficiency is maximised when the trial developers draw on previous experience, leveraging the perspective and expertise of the contract research organisation (CRO), the sponsor and the sites. Refining each of these details individually improves the overall trial. Operational agility can also be built in from the start. The goal of a clinical trial is to identify the right drug and the right dose to have to right effect, within constraints including safety, price and time. In a classic design, pre-clinical or comparative studies will suggest the endpoint, safety considerations, dose range and therapy windows. An agile clinical trial design builds in opportunities
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