Clinical innovation: using digital solutions to deliver the next wave of medicines
Rapid progress in digital health technologies is enriching clinical trial design, improving clinical trial recruitment strategies and harnessing the power of clinical trial data to improve outcomes for patients and guide future research. Here, Natalie Fishburn, Cristina Duran and Serban Ghiorghiu, from R&D at AstraZeneca, discuss the evolving nature of clinical innovation in the age of precision medicine and how digital solutions are being used to enhance the experience for those involved in clinical trials.
In a typical year, AstraZeneca conducts over 240 global clinical trials, involving more than 123,000 patients in around 60 countries. For clinical innovation to deliver life-changing and potentially curative new medicines to patients as quickly and safely as possible, diverse digital and other technologies are increasingly being used to optimise clinical trials to get more medicines to more patients, faster than ever before. The move towards precision medicine is necessitating changes to the design and execution of clinical trials. The upsurge in digital healthcare during the COVID-19 pandemic has catalysed changes in clinical trial recruitment and participation. The ambition is to use technological and digital solutions to reduce the burden for patients and trialists, so that clinical trial participation ultimately becomes part of daily practice.
Designing clinical trials with patients in mind
Incorporating the patient voice into the initial planning process of our trials ensures that our designs are manageable and understandable, as well as feasible and practical.
Much can be learned from previous clinical research. Through Merlin, an internal AstraZeneca artificial intelligence (AI) and predictive analysis tool, some of our study teams are aiming to optimise the design and cost of new trials based on experience from previous study designs, including reducing patient and investigator burden and carbon emissions. The data leveraged by Merlin can help to increase patient recruitment and create diverse patient cohorts that are more representative of the patients typically seen in clinical practice.
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Optimising clinical trial design
To get medicines to patients faster, clinical trials need to be more efficient, with fewer delays and lower costs. Adaptive trials, basket studies, platform trials, synthetic control arms and dose optimisation studies are some of the options for achieving these goals.
Introducing real world control arms to clinical trials has the potential to reduce the need for placebos and the burden of study participation for both patients and investigators. Comparing novel agents with routine care could require fewer patients for the overall study. Using control data from matched patients in earlier studies could reduce the need for control arms altogether. Such options would require significant changes to current clinical trial regulations, but there is undoubted interest in their potential advantages for reducing trial burden.
More information here.