Applied Clinical Trials
The Pistoia Alliance, a global, not-for-profit alliance that works to lower barriers to innovation in life sciences R&D, has launched a new series of programs to help organizations collaborate on advancing the role of digital technology within life sciences R&D and healthcare. As part of the Pistoia Alliance’s strategic refresh, defined by its 2030 vision report, the Alliance has created this initiative to bring together all stakeholders with an interest in digital health technologies; the goal is to develop projects that deliver real, tangible outcomes. The first project in this stream is being undertaken in collaboration with The Digital Medicine Society (DiMe) and will explore the quality generation and ethical use of digital health data in clinical studies. The project will analyze how a digital, real-world data collection tool is used during a clinical trial, aiming to define standards for collecting patient-centric data in a way that provides value for a particular therapeutic area.
“Using digital technologies in life sciences needs a pragmatic approach. The potential is huge, but many organizations are only talking about or piloting digital projects, rarely delivering tangible sustainable outcomes and with many organizations’ projects simply duplicating efforts of their peers,” said Professor Ashley George, Co-Founder of The Pistoia Alliance. “Our projects are developed in response to our members’ challenges and realizing true patient centric value from ‘digital’ is a universal problem across all aspects of life sciences. For this first initiative, we turned our attention towards clinical trials because this is a resource intensive area of R&D and to date, data stewardship during trials-and indeed, across the life sciences industry in general-has been poor. Digital so far has promised a lot but sustainably delivered relatively little. If we want to see real digital transformation with real benefits for patients, companies need to work together and invest more to ensure the patient experience is interoperable and seamless-both for apps and digitally enabled physical devices.”
Digital technology has become increasingly prevalent in clinical trials, thanks to patient wearables, in-house monitoring, mobile apps for collecting data, plus cloud and automation technologies. This not only enables more innovative trials but improves the patient experience since they can be conducted virtually-crucial also in light of social distancing measures and travel restrictions brought about by the COVID-19 pandemic. However, these technologies collect large volumes of data, and since there is a lack of agreed metrics and standards for managing them, the ability to draw inferences and firm conclusions-or even to allow patients to share their own data-is limited. Indeed, in a recent survey conducted by the Alliance, almost half (46%) of respondents said a lack of industry wide data standards is the biggest barrier to collecting and leveraging patient data. This project will address these problem areas by producing real-world outcomes, providing beacon projects showing consistency in how digital medicine tools are used in clinical trials, and how the data they collect are captured, recorded and shared.
“It’s crucial that the life sciences industry comes together to collectively advance the use of digital technologies to speed the development of new medical products,” said Jennifer Goldsack, Executive Director at DiMe. “The Pistoia Alliance’s dedication to encouraging knowledge sharing and the establishment of industry best practice is why we are pleased to partner on this project. By collaborating with key members of the industry, we aim to begin to address the lack of standards for digital technologies and how we capture patient data.”
“In our consumerized world, building digital tools isn’t difficult, but generating quality outcomes from them is,” concluded Professor Ashley George. “That’s why by launching this initiative, we aim to bring together everyone in the life science community, from big pharma companies to technology vendors, software and hardware developers, academics and start-ups who are all Pistoia Alliance members. We’re also keen to support the investor community, which is often looking for worthy digital projects in which to invest. Ultimately, having the humility to collaborate is essential for projects like this to benefit patients, and thus the whole industry and value chain, which is why we’re now calling on organizations to come forward and get involved to co-create.”
Data stewardship is hugely important to The Pistoia Alliance and is fundamental in accelerating R&D, with the Alliance pioneering a range of projects championing the importance of sharing and standardizing data-including its recently launched FAIR Toolkit and Unified Data Model. This new digital initiative stream is part of the Alliance’s strategic refresh following the publication in 2019 by the Pistoia Alliance of a report exploring the impact of technology in the next decade. The report, 2030: Life Sciences and Health in the Digital Age, draws on insight from 75 industry experts from 65 major organizations, and aims to help organizations in the sector understand and prepare for new innovations in the coming years.