Decentralising Clinical Trials for Better Drug Formulations

Decentralising Clinical Trials for Better Drug Formulations

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.

The concept of conducting trials where patients live significantly predates the pandemic. In an effort to overcome cost, complexity, and participation issues, pharma’s developers began to innovate clinical trial design, seeking to improve every aspect of the patient experience. For example, 70% of potential participants live more than two hours from trial sites, so decentralisation broadens trial access to reach a larger number and potentially a more diverse pool of patients. McKinsey notes decentralisation can help reduce trial investigator workloads because traditional clinical site activities (drug administration, assessments, and data verification) can be performed remotely by technicians or by trial participants themselves.

Clinical-trial sponsors continue to seek ways to help clinical trials be faster and more cost-efficient while improving the experience for all stakeholders, especially patients. Decentralising clinical trials and managing their remote execution with patients using digital technologies has emerged as a critical tool in the pursuit of trial participation and patient data diversity goals. The move toward shifting clinical trial administration to where patients are is being supported by innovation and a broad range of enabling technologies. Across the industry, sponsors are implementing virtual trial models and hybrid models to improve clinical trial efficacy, safety, and, above all, patient access.

The following are emerging “E” enabling technologies and are helping clinical trial designers take a decentralised approach to conduct clinical trials:

Data on clinical trial recruitment reveals troublesome, systemic issues. A recent report revealed that  20% of cancer clinical trials fail because of inadequate patient recruitment. Average enrolment efficiency was also reported to be less than 40% for Phase III and IV trials. Globally, more than 80% of trials fail to enrol on time, resulting in an extension of the study and/or the addition of new study sites.

Fortunately, several innovative solutions utilising  artificial intelligence (AI) are emerging to help match patients to the appropriate clinical trial. AI-driven information technologies can be leveraged to analyse structured and unstructured clinical data and match it to clinical trial criteria. Post-analysis makes it simpler for investigators to identify and contact potential patients for clinical trials. Platforms that integrate electronic recruitment capabilities, telemedicine with screening,  consent forms, and patient-reported data and outcomes can support more efficient patient engagement, from recruitment to post-approval patient studies.

Discover more: https://www.pharmafocuseurope.com/clinical-trials/decentralising-clinical-trials