PHASTAR at SCDM 25 - conference summary
The theme of the 25th Society for Clinical Data Management (SCDM) annual conference in Baltimore was to raise awareness of the upcoming trends in the industry and reflect on how they will affect the clinical data management community.
The leadership forum convened a day ahead of the conference. It was an excellent opportunity for industry experts to come together, present their views and discuss how emerging study designs, regulations, and technology innovations are reshaping the role and profile of clinical data management. The core of our discussions was the first of 3 whitepapers from the SCDM released in June 2019, “The Evolution of Clinical Data Management to Clinical Data Science.”
There were excellent presentations which sparked lively debates on complexity of clinical research approaches, such as adaptive study design, umbrella studies, real world data, virtual trials and how evolving technologies such as Artificial/Augmented Intelligence (AI), Machine Learning (ML) and wearables are transforming the clinical trial landscape. A key topic focused on the skill-set that ‘early career professionals’ must now learn and demonstrate to support evolving technology and processes and how the data management sector should attract newcomers into a highly regulated industry that hasn’t evolved as quickly as other tech sectors. Their skills and expectations will be drivers for the evolution of the clinical data scientist role.
The SCDM has been fortunate to benefit from a strong relationship with regulatory bodies. We were joined by members of the FDA and the Danish authority, who presented their approach and expectations amongst the challenges of a shifting regulatory environment. In an open, relaxed exchange of viewpoints, requirements for system validation including AI, audit trails, risk management and inspection findings were deliberated. The biggest conundrum was how we will meet the forthcoming European legislation which requires trial data to be stored for 25 years. Who knows what formats and storage facilities will be around by then – just think back to what was in place when the SCDM set out 25 years ago.
The keynote speaker, Kent Thoelke, kicked off the conference with a call for a paradigm shift from our current status of ‘analogue’ clinical trials to an embracing of the digital technologies that have already been shown to improve patient recruitment and participation in trials, compliance and health outcomes. He conveyed the message, in a compelling manner, that we need to drive forward efficiencies in drug development through these tools and reminded us that we have a duty to ensure that every patient has the best possible access to the best treatments at the earliest opportunity.
‘Data Driven’ was the motto of the meeting and the 37 sessions covered all aspects from implementation of risk based monitoring (RBM) and its challenges, eSource and ePRO and bring your own devices for patient-centric studies, to how AI can take on the routine data cleaning tasks releasing data managers to more fully understand the data in the context of the study.
It was an invigorating conference and exciting to know that PHASTAR are already leading on many of these initiatives. Through our EDC suppliers, Medidata and Medrio, PHASTAR have eSource and ePRO capabilities. We have established RBM procedures and our data science experts have successfully applied ML to clinical trials to add business value.
PHASTAR’s experienced data management team advise and support all aspects of data capture and analysis, from eCRF design through to database lock.