CluePoints - paving the path for risk-based quality management and sharing insight at DIA Global

OSP caught up with Patrick Hughes, co-founder of CluePoints to discuss in more detail the company's plan for the show, what they are bringing and how they can help their clients. 

OSP: What are you hoping to bring to DIA?​

PH: CluePoints was the first company to bring Risk-Based Quality Management (RBQM) technology to the market, 11 years ago. As pioneers in this evolving sector, we recognize the importance of educating the industry on the value of this approach, the need for regulatory compliance, and how to implement the methodology effectively.

At DIA Global, we aim to share our insight and experience to help pave a path for future adoption and utilization of RBQM. We recently conducted a global study with the Tufts Center for the Study of Drug Development and plan to share how the results correlate with the latest draft ICH E6 Guideline for Good Clinical Practice (ICH E6 (R3)).

OSP: What are you hoping to take from the event?​

PH: CluePoints is continually investing in artificial intelligence (AI) initiatives that improve the utility of our RBQM platform. We have, for example, used Machine Learning (ML) to help study teams reduce their manual review efforts, by automating key tasks such as the grouping of risks and centralized monitoring study setup by extracting valuable insights from past trials.

However, neither technology nor our industry ever sit still, and there is always more to develop and improve upon. DIA Global gives our teams the opportunity to ensure they are up to date with the latest trends, insights and techniques in their fast moving fields and apply that knowledge to their everyday - and future - work of making clinical trials safer, streamlined and more efficient.

OSP: What key tracks presented at DIA Global Annual Meeting 2023 are of particular note for you and why?​

PH: There is so much going on at DIA Global this year that it is hard to choose.

At CluePoints, we are continually investing in statistical and AI techniques that help our clients extract every drop of potential from the RBQM-driven interrogation of their own datasets. As such, we’re excited for the sessions on the use of ML and AI in drug development, part of the statistics track, and ML in real-world data, in the data and technology track.

Of course, RBQM is our raison d'être, so we will also be keeping a keen eye on the clinical safety and pharmacovigilance track, which includes a talk on benefit/risk assessments and risk management.

OSP: DIA talks of the ‘issues of today and the possibilities of tomorrow’ – how do you view those and do events like DIA help address those? ​

PH: Technology continues to transform the clinical research space in front of our eyes. Approaches such as RBQM, for example, have the proven power to improve data quality and integrity within clinical trials in a timely manner. Adoption, however, can be challenging.

The industry, quite rightly, works to a strict set of rules and regulations that place huge emphasis on the role of process in protecting patient safety. These processes have been “baked in” to research over decades, and concerns that altering them could compromise safety, data quality, or regulatory compliance can make sponsors resistant to change – the Silicon Valley motto of “move fast and break things” does not apply to people’s health.

Technologies such as RBQM are now proven to improve quality without compromising safety and even have the backing of regulatory bodies around the world, including the FDA, but the natural conservatism of the industry can often hold adoption back despite the need for a paradigm shift in the way trials are managed.

Events like DIA Global, which bring the industry together to discuss the evidence and the regulations, and learn about the practicalities of implementation, help us all to turn possibilities into the much-needed reality of more effective and efficient clinical research.