There is now potential for a step-change in productivity. Across the drug discovery and development value chains, there is a drive to apply automated methods to yield greater efficiency, such as in laboratory research. Automated approaches will also define the next era of efficiency in clinical trial analytics.
Removing reliance on manual programming tasks and embracing automated methods can enable a more seamless data flow, from protocol design to data submission, enabling faster results, higher quality, and improved consistency.
End-to-end automation is a ‘computer-aided design’ paradigm shift, in which clinical trials will be designed, or modelled, collaboratively upfront. They will use new software tools, based on existing clinical data standards but extended to include machine-readable biomedical concepts.
The digital model of a clinical trial will be stored as metadata, automating the digital data capture, analysis and reporting systems that are configured manually today.
A world of end-to-end automation would eliminate the need to start from scratch with every new trial. Instead, relevant aspects of previous trials could be harnessed to build out studies, without having to trawl through legacy paper trails.
However, this new era will not come in a single leap. In order to achieve the ultimate vision of end-to-end data automation, a stepwise, incremental approach will be necessary.
First, the existing standards framework must be enhanced and developed. While extremely valuable, the current CDISC standards have been developed for manual processes. To drive automated analytics and reporting, more detailed information will have to be specified within them, in the form of metadata.
Next, duplication must be eliminated. Clinical trials typically involve a network of organisations and stakeholders; sponsors, CROs, data managers, statisticians, medical investigators, and writers, to name a few. The numerous manual steps involved in moving from protocol design to clinical study reports and data submissions involve significant duplication of effort across these different roles. Investigators design the trial protocol and the data management team translates that document into a data capture tool that repeats information, such as the number of study visits. Then, statisticians produce the statistical analysis plan, reiterating much of the same information. Moving to a genuinely electronic and interactive data source document would be a foundational step in eliminating redundancies, allowing all stakeholders to extract the information they need from a single point.
The next step towards automating clinical data analysis is to read in the protocol at the outset, extract the data from the data collection tool, and transform it into TFLs and informative data visualisations without the need for time-consuming manual programming. Fully harnessing the power of automation could enable the delivery of actionable insights to medical stakeholders in real time to inform in-stream decisions in days or hours, rather than months.
The transition from manual to automated approaches brings unique challenges and considerations. Many pharmaorganisations are still grappling with the technology stack required to implement solutions, including enterprise tools to support central data repositories and data transformation steps. Outside the life science industry, data scientists use different tools, standards, and languages to automate data analytics. The industry needs to consider what it might need to bring into its toolkit. For example, it is now diversifying its statistical programming capabilities beyond traditional SAS software with open-source programming languages, such as R. R’s growing community of users provides a strong foundation for collaboration and innovation.
As well as having the right technology in place, different complementary skillsets must be considered, such as data science skills in data systems and ML to complement traditional clinical trial reporting skills in statistics and statistical programming.
Where could this lead in the longer term? The ability to analyse more trials more quickly to a higher quality standard would, in itself, deliver substantial efficiency gains.
At a more aspirational level, harnessing automation tools and advanced analytics could help to de-risk the clinical development process, by systematically leveraging clinical trial and real-world data insights to make better decisions throughout the product lifecycle, from drug discovery onwards.