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IN PARTNERSHIP


How decentralised trials make research more accessible and inclusive for participants and sites


Sinéad Callinan, executive director of delivery EMEA at THREAD, looks at how decentralised clinical trial (DCT) approaches can increase participation among under-represented groups.


comprehensive data needed to ensure that a new treatment will be safe and effective for everyone. A 2018 study reported that a staggering 86% of study participants are white, while another found that, in the US, African Americans make up 43% of all cases of SLE (systemic lupus erythematosus) but only 14% of clinical trial participants. The safety and efficacy of drugs or biologics can vary significantly based on an individual’s sex, race, age and other traits, so enrolling homogenous populations in studies can result in data gaps that hide serious concerns for under- represented groups.


T 42 | Outsourcing in Clinical Trials Handbook


raditionally designed clinical trials chronically struggle to enrol representative patient populations that will yield the


Having worked with both patients and sponsors in clinical trials for many years, I’m all too familiar with the wide range of factors that get in the way of trial participation. In particular, distance from large medical centres and lack of information about clinical trials can severely limit access for patients, many of whom would otherwise add crucial diversity and potentially benefit from participation. I’ve therefore been excited to watch


decentralised clinical trial (DCT) approaches become more widely adopted because of their potential to democratise access to research. In order to produce the most accurate and reliable data about each new drug’s efficacy and safety, we have to meet participants and under- resourced sites where they are.


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