A new study from Tufts Center for the Study of Drug Development (CSDD) highlights the need to transform clinical data management practices to enable risk-based approaches and reveals the root causes for delays and inefficiencies impacting trial timelines.
Results
The data, which will be presented at DIA 2018 annual meeting, is in follow up to the 2017 eClinical Landscape study — sponsored by Veeva Systems — and has involved input from more than 40 data management executives about the top challenges and opportunities in clinical data management.
From this study, it was found that there is a significant opportunity to transform data management practices for greater agility and to accelerate adoption of risk-based approaches. Currently, protocol changes, amendments and uncertainty in finalising the protocol design cause upfront delays that have a negative downstream impact on key data management activities. Clinical leaders indicate that improving processes for early consensus and leveraging modern, agile systems that better adapt to protocol changes can significantly streamline execution and speed timelines.
Additionally, concerns were raised by executives included in the study about the ability to manage data beyond eCRF. It is believed that by having a steady stream of comprehensive and clean data throughout the trial, much of it can be prioritised through risk-based approaches, assisting in faster decision-making and shorter overall cycle times.
“Protocol design is taking longer to finalise and undergoing more iterations, creating challenges in data management and overall trial efficiency,” said Ken Getz, research associate professor and director at the Tufts Center for the Study of Drug Development. “Also, data volume supporting clinical endpoints is rapidly increasing. More data comes from sources other than eCRF and lab data, creating substantial integration and coordination difficulties for data management.”
“There is tremendous opportunity to address the limitations of traditional data collection to accelerate clinical trial timelines,” commented Henry Levy, chief strategy officer at Veeva. “As the number of data sources continues to rise, data management teams will have a greater need to see all their clinical data, at all times. Veeva’s vision is to help organisations seamlessly bring their data together throughout the course of a trial and make the transition to risk-based trials where data is collected and analysed for a current, holistic view of the patient.”