Digital toolkit encourages collaboration in pharma R&D

The Pistoia Alliance, a not-for-profit organisation aiming to improve innovation in life sciences R&D has launched a series of programmes to encourage collaboration on advancing the role of digital technology. 

As part of the Pistoia Alliance’s strategic refresh, defined by its 2030 vision report, the organisation 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, Pistoia said in a statement, and the first project in this stream is being undertaken in collaboration with The Digital Medicine Society (DiMe). 

It will explore the quality generation and ethical use of digital health data in clinical studies. The project will analyse 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.  

Digital technology has become increasingly prevalent in clinical trials, thanks to patient wearables, in-house monitoring and 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. 

 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 standardising data – including its recently launched FAIR Toolkit and Unified Data Model.