Recently, there has been significant industrywide momentum toward streamlining clinical systems and processes. 

The Veeva 2018 Unified Clinical Operations Survey examines the life sciences industry’s progress toward a unified clinical environment by gathering the experiences and opinions of 331 clinical operations professionals from around the globe. The latest findings reveal that nearly all (99%) of clinical leaders surveyed cite the need to unify their clinical environment. 

Many have also prioritized modernizing their clinical processes, including the adoption of certain applications. That number has quadrupled since 2014, and a majority of respondents to Veeva’s survey (83%) say they have, or plan to have programs to improve study start-up processes. Standalone eClinical applications are now the norm as sponsors and CROs have steadily adopted function-specific clinical technologies. 

While the industry is advancing their clinical processes in those ways, significant opportunities remain to further improve efficiency in other operational areas. 

Contract Pharma spoke with Veeva’s EDC vice president, Richard Young, about the challenges that companies are still facing within clinical processes, and what can be done to expedite change.

Contract Pharma: What are the biggest contributing factors that cause delays in clinical trials?

Richard Young: Increasing complexity in protocols and the regulatory landscape have contributed to extended timelines, but it is also clear that current technologies have failed to meet these challenges. Research shows that the penalties associated with starting database design early and having to course correct due to protocol amendments and changes are significant and result in organizations delaying trial conduct and completion. Clinical data management leaders recognize that technology should help overcome these challenges and improve clinical trial processes. Today, EDC solutions are slowing study build and making it difficult to manage the increasing variety and volume of data, ultimately delaying trial execution and study close out.

CP: What are some steps to making the clinical trial process more efficient across the board?

RY: Technology, processes, and people need to be re-connected. As we look at the key objectives for each trial participant, manual and redundant processes commonly run in parallel, so there is significant opportunity to improve trial effectiveness and productivity. The industry agrees clinical data needs to be more like a giant Lego set. Use different blocks for every study, in unique combinations, that just fit together. A modern EDC can help overcome these challenges and enable the collection, aggregation, and risk-based management of all data. Having all of your data in one place all of the time will change everyone's ability to use data and convert it into true actionable insights. But we are still using outdated, decades-old clinical technologies that are inflexible and slow. A modern technology approach can eliminate many of the challenges that exist today, including database migration which is a significant pain point for many companies. 

CP: When it comes to data management within trials, what are some of the key issues the industry sees, and what are the solutions?

RY: Database migrations is one of the key issues organizations face today because traditional EDC solutions are slow and expensive in two key areas: protocol amendment related database changes and system version upgrades. Clinical data management leaders discussed the inability to manage system control and validation and highlighted that the cost of amending the study design after the study was live was a significant challenge. Upgrading to the latest EDC system is just as difficult because among traditional EDC providers, there is no EDC system available that is a true SaaS, cloud solution. In each case, database migrations are the norm every time a data change needs to be made or a system needs to be upgraded. The solution is an EDC system that delivers greater flexibility in managing protocol changes and collecting new data during a trial, as well as provides a modern SaaS approach to continually deliver cloud innovation so that the system gets better over time. This would eliminate the need for database migrations altogether and, ultimately, drive much faster product development and innovation.

CP: How has the average timeline for a trial changed throughout the years, and has it had an impact on efficiency?

RY: Our expectations for patients have significantly changed, with trials generally being longer and more demanding than ever before. While there are certainly clinical demands that are unique for each trial, there is significant opportunity moving forward to drive much greater efficiency at the start and completion of studies by introducing more modern clinical data management processes and taking the most effective path from start to completion.

CP: What effect does the increasing amount of technology and non-traditional sources CURRENTLY have on trials running smoothly, and is there opportunity there to use it for good (acceleration)?

RY: Absolutely. We have seen the gradual fragmentation of clinical trial processes, caused in large part by traditional EDC systems taking a page-driven, sequential, and linear approach to clinical data. We do not manage pages, we manage patients and people. The sooner we get away from this antiquated concept and move toward a state of complete and concurrent data the faster we will be able to transform traditional clinical data processes. We will continue to collect more data – from images to patient reported outcomes and data from wearable devices – and unstructured data will become mainstream. Technology must rise to the challenge to handle structured and unstructured data and connect them in ways that will facilitate a harmonized patient view.