In an ecosystem modulated by a working balance between patients, emerging science, and funding capital, patients and advancing technology are seemingly taking center stage in driving innovation in clinical trials.
At the 15th Annual Outsourcing in Clinical Trials East Coast conference held on 21 – 22 May in King of Prussia, US, experts shared this sentiment while deliberating the existing challenges and the procedures that must be implemented to put patients at the true centre of clinical trial operations.
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Patients and caregivers
Though trial sponsors are typically positioned to direct the flow of innovation, and regulators lay the guidelines for innovation, Craig Lipset, advisor and founder of Clinical Innovation Partners, noted that patients also have the motivation and incentive to advance trial innovation across the drug development ecosystem.
Access to innovative tools and processes is no longer a privilege for big corporations, he says. Organised and incentivised patients are in the driver’s seat of drug development and are in optimal positions to catalyse innovation, he adds.
The trial site, staff, and investigators largely determine the patient experience and how both patients and caregivers feel throughout the study, explained global head – Growth & Insights at the patient-owned cooperative Savvy Cooperative Kelly Franchetti. As a result, supporting the patient throughout a clinical trial’s lifecycle and understanding the burdens experienced by patients is key to success.
Diversity, equity, and inclusion
In addition to the focus on patients themselves, panellists at the conference also took note of the importance of a truly diverse and inclusive enrolment population, doubling down on the lingering problems and diversity barriers in patient recruitment.
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By GlobalDataMohammed Ali, the M&D Head of Reporting, Analytics, and Insights at Astellas Pharma said that data—however crucial for benchmarking and standardisation—presents challenges for diversity, as data collection is limited to age, ethnicity, sex, and race of the enrolled patient. Moreover enrolling truly diverse populations requires the field to determine exactly what “diversity” entails.
Also on the panel was executive director of the Rare Disease Diversity Coalition, Jenifer Waldrop, who explained that while clinical trials have not traditionally allocated the time, talent, and monetary resources required to capitalise on diversity, organisations and advocacy groups may serve as the catalyst to enrol more diverse clinical trials.
The future of decentralisation
Decentralised clinical trials (DCTs) became popular during the Covid-19 pandemic, and their use grew in the following years as Clinical Trials Arena’s DCT Adoption Tracker recorded a 9% decrease in DCT activity in 2022 compared to 2021. However, since then, decentralisation in trials has slowed down. Still, certain elements of decentralisation are likely to grow across various clinical trials, experts on a DCT-centered panel said.
“Eventually, intuitively, the cost [of DCTs] will be lower in the long run,” said Ram Raju, former senior Vice President and Community Health Investment Officer at Northwell Health. Despite the potential benefits, technology-related burdens that have shifted from hardware to software-related challenges remain a challenge for sites. Decentralised procedures must employ “very intuitive” devices that are available in multiple languages and facilitate the trial process for patients, explained Rosanne Petros, associate director,Clinical Research at Merck Research Laboratories.
While DCTs are advantageous for patients due to the accommodating nature of this approach, the industry needs to learn from DCT implementation during Covid-19 and build a framework for hybrid study design that combines aspects of decentralisation and conventional trials going forward, said Kristen Olszyk, acting Head of Clinical Operations at Chesterbrook, Pennsylvania-based biotech Neuraptive Therapeutics.
Charting a patient centric future
The objective of patient centricity is knowing your population and ensuring that they understand how they, as individuals, will be impacted by clinical trial processes. “Are you talking to that patient population? And actually talking to them, not the ecosystem that surrounds them?” asks Franchetti. She goes on to say even though patient feedback may be collected in a trial, often, this is carried out as an afterthought as opposed to proactively.
“We have an industry where 90% of clinical trials are conducted in 5% of the countries,” Harsha Rajasimha, MS, Ph.D, Founder and Executive Chairman of Indo US Organization for Rare Diseases. Understanding the prevalence of a disease globally while disregarding geographic boundaries and crafting an inclusive strategy is a fundamental challenge in patient centricity, Rajasimha added.
