According to a last year’s research on checking the pulse of the pharmaceutical industry’s use of trial master file (TMF) and collating feedback from 217 TMF managers from across the globe shows humongous change is under way as the industry shifts from passive to active TMF management and adopts advanced electronic TMF (eTMF) applications to improve inspection readiness and shorten clinical trial times, Rik van Mol, Vice President of R&D Strategy, Europe, at Veeva Systems, responsible for the Veeva Vault R&D suite of applications writes on pharmexec.com.
There is also an emerging gulf emerge between those organizations that use data to drive efficiencies and those that do not have the capability to access critical trial information due to outdated systems and practices, van Mol writes.
First, we need to understand why TMF processes are so important. Regulatory agencies are demanding higher levels of access to TMF processes, and at the same time life sciences companies need ways to make the TMF process more efficient.
These dual challenges have helped build the business case for eTMF processes. An active eTMF gives regulators access to up-to-date trial data to check on Good Clinical Practices (GCP) compliance, as well as improving productivity and providing valuable performance insight on which life sciences executives can base business decisions, notes the report.
Passive TMFs involve out-of-date, paper-based processes, even if documents are saved in electronic format, and these are often saved loosely in multiple locations and users cannot track progress. Conversely, with active TMF management, purpose-built eTMF applications manage documents and processes in real time as the TMF is being generated. Documents are created, reviewed, and acted upon in one system that is accessed by all study partners.
Current State of TMFs in 2016
The 2016 Paperless TMF Survey1 finds that organizations are improving their ability to respond to regulatory requirements, although as an industry we have a long way to go. According to our survey, the vast majority (80%) of sponsors using eTMF applications now provide remote access to inspectors and auditors, or plan to do so in the coming twelve months.
Improving inspection readiness (67%) and speeding study start-up (53%) are the two most cited business benefits driving eTMF adoption among sponsors. We are in a period of maturation when paper-based practices are disappearing and digitized practices are ascending. Our survey reveals that the maturity of TMF processes varies widely from passive TMF management to more advanced active TMF processes. In a move to go paperless, almost half (49%) of sponsors say integrating their eTMF applications with their clinical trial management systems (CTMS) is key.
Using Data to Improve Processes
The pharmaceutical industry is benefiting from the increased access to data and making strategic decisions based on it. The study further finds that organizations that have already adopted eTMF applications report better visibility into performance metrics (55%). What is more, those organizations using metrics to improve trial processes see far greater benefits compared to those not currently collecting data and these include improved audit and inspection readiness (67% compared to 29%), better visibility into performance metrics (53% compared to 14%) and cost savings (47% compared to 10%).
Role of Metrics
Stating that metrics play a critical role in speeding up time to market during the trial process, the report goes on to say that the respondents using eTMFs and metrics diligently experience other advantages over those not collecting data, such as faster study start-up time (20% compared to 5%) and shortened clinical trial time (23% compared to 5%).
Effective use of Data
There remains an opportunity to use data more effectively in eTMF processes. Despite the clear benefits offered by increased access to data, we observe that TMF owners’ use of operational metrics remains flat. The number of respondents who are “extensively using data” grew from 14% to 18% in the last year.
Using an eTMF is becoming a natural part of the clinical trial process workflow, which ensures that study findings are reported as they happen and status reporting is more accurate and effortless. Real-time insight into trial progress allows the entire team to collect data throughout studies and use that data to make better decisions about commercial strategy and therapy effectiveness, van Mol concludes.