SCDM 2019 Key Message: Focus on study OUTCOMES not OUTPUTS

Written by Claire Bennett, Director of Clinical Data Management

Studies are more complex than ever and collect more data than ever before from multiple sources. A new drug now costs in excess of $2bn and takes over 10 years to get to market…. assuming it makes it that far!

Statistics show that less than 5% of patients participate in clinical trials. That means more than 95% of patients are potentially waiting up to 10 years for new or better treatments.

In his opening keynote presentation at SCDM2019, Kent Thoelke said “We have a moral imperative to fix the model – to ensure that every patient has access to the best possible care.”

But I’m ONLY a Data Manager.…. what can I do??

This is a gross simplification but, essentially, ICH GCP E6 (R2) encourages the utilization of technologies to take a risk based, “fit for purpose” approach to data validation.

We are the custodians of the data and we define the data validation strategy. By understanding the key study objectives and data sources, we can focus the review on the data that matters. If the data has an impact on the conclusions of the study – it matters! We may not want to hear it, but we no longer need to strive for perfection and zero errors.

Endorsed by the E6 (R2) addendum, the traditional heavy reliance on subject level point to point data validation is being replaced by aggregated, study level validation, leveraging centralized data integration, defined risk and quality thresholds coupled with use of analytics and review tools to drive targeted review of eCRF and non-eCRF data.

Advances in technology mean that data review is focused, faster and more efficient. Such centralized, aggregated data views enable us to restore our sense of connection with the data and free us up for higher value data surveillance tasks.

Our role is evolving from that of the historical Data Manager to the ‘Clinical Data Scientist’ role. A role, endorsed by the SCDM, that has technology, complex trial designs and tailored risk-based approaches at its heart.

Simply put, focusing validation on data that impacts the study outcomes, rather than outputs, results in earlier access to reliable, credible, “fit for purpose” data and lower running costs.

Speakers at the SCDM 2019 conference in Baltimore last week articulated this message to a very engaged audience and it was further endorsed by industry key opinion leaders as well as the main regulatory agencies.

At Cmed we leverage Cmed’s encapsia clinical data suite. It serves up a single, aggregated representation of all data (eCRF and non-eCRF) where stakeholders can query, clean, visualize and scrutinize clinical data in real-time. Speed of decision making is key for trial sponsors. encapsia promotes proactive decisions on patient eligibility, data validity and point-in-time analytics to allow data trends and patient profiles to be established and directly accessible. At the same time, Live Site Performance Scoring Dashboards and Progress Reports enable the study team to have clear oversight of, and act upon, potential areas of risk.

We are Cmed Clinical Data Scientists and we are implementing new technologies and processes, supported by E6 (R2), to bring new, more effective treatments to more patients and improve or extend lives.