Modernising the clinical trial: a shift to decentralised trials driven by advances in technology and catalysed by the COVID-19 pandemic

Nancy Cross, Senior Analyst at Lightning Health presents a research poster at ISPOR Europe 2021 on payer awareness and perceptions of decentralised clinical trials. (POSB278)

View the poster here

The conventional randomised clinical trial (RCT) has been the gold standard for clinical development for decades, however the role and value of decentralised clinical trials (DCTs), where patients are not required to attend the trial site on a regular basis, is growing in acceptance and being widely discussed in medical literature. The change in perception of DCTs has been driven by advances in technology such as increased analytical capabilities, and more recently the COVID-19 pandemic, accelerating the overall uptake of DCTs.

We wanted to explore the awareness and perception of DCTs among payers in Europe and the US through this research, ensuring that our work added value to existing literature by including payer insights.

We used the Lightning Insights platform to explore both the awareness and perception of DCTs amongst payers in the EU4, UK and US, including the potential advantages and disadvantages for informing payer evaluation of new medicines. By using the Lightning Insights platform, it was easy to programme the questions that we wanted to explore, using a range of question types and scoring to obtain quantitative data, with the opportunity for respondents to give qualitative answers to explain their reasoning. It was a quick process that allowed respondents to complete their answers in their own time.

Our research found that the attitude of payers is generally positive towards a decentralised approach for clinical trials. It appears that increasing use of DCTs is widely expected by payers, although how this will be implemented is still unclear, with potential for a ‘hybrid’ approach with an RCT to meet the optimal requirements for clinical development for a specific product or indication.

RCTs have been the gold standard for over 70 years so there is naturally going to be a hesitancy from payers and regulators regarding the acceptance of DCTs. Payers can see the advantages of these clinical trials, however significant research and education is still required to provide reassurance that this is an appropriate methodology for clinical development, and this is going to take some time.

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Article published 1 December 2021.