CLINICAL TRIALS
Decentralising Clinical Trials for Better Drug Formulations Achieving Patient Data Integrity & Fulfilling Diverse Pharma Needs Patient data is at the centre of the clinical drug development process. Data diversity is too. Drug developers and pharmacologists have always looked at collecting datasets from diverse patient groups to assess the efficacy and safety of medications in clinical trials. However, acquiring diverse patient data is exceedingly challenging due to a wide range of social and physical barriers that prove to limit trial participation. Fortunately, technical innovation, as well as general public access to the cloud, are helping pharma’s researchers raise trial participation rates, increase patient diversity and move the industry away from centralised site-based trial administration models. Claude Price Head of Clinical Data Management, Quanticate
Trial decentralisation trending faster post-pandemic The pandemic significantly accelerated the decentralisation of clinical trials and saw more data being captured off-site, remotely from participants in real world settings. According to McKinsey, because health-system resources became consumed by COVID-19-related care and travel became limited by physical distancing, patients’ access to trial sites was reduced by 80%. The impact of a pandemic on clinical trials and participation was significant. The number of trial starts monthly declined by 50% from January 2020 to April 2020, with 60% of the investigators reporting a significant reduction in trial activities by as of May 2020. This prompted drug sponsors to increasingly adopt remote consent and patient monitoring, video conference assessments, and even self-administered phlebotomies. 50
P H AR M A F O C U S E U R O PE
ISSUE 01 - 2022
