It’s a time of great evolution for clinical research. Recent years have seen a major expansion in the size and scope of industry operations. It’s increasingly common for clinical trials to cross borders, oceans, and continents.1 Studies and datasets are bigger, and protocols are more complex.2 All of this makes for a more intricate research environment than previous generations of sponsors and CROs ever imagined. Navigating that intricacy without jeopardizing study timelines is one of the definitive industry challenges today.
Fortunately, the industry has at its disposal an ever-growing, ever-prevalent array of eClinical tools to mitigate those challenges. This, however, presents problems of its own: if not optimally designed and equipped with the necessary functionalities, these tools can actually make timelines even more vulnerable. They can require a lengthy and cumbersome study build process, or have limited capacities for the import and export of data, leading to inefficient manual transfer between systems and databases. Last year, CenterWatch released a report on the ways eClinical technology, rather than streamline clinical operations, can actually create more inefficiencies.
Electronic data capture (EDC) and other eClinical tools are meant to alleviate, not worsen, research challenges. Sponsors and CROs must take great care to ensure that the EDC they select can help to make their increasingly large and complex trials move more smoothly – rather than the opposite. Here are some things they should keep in mind during vendor selection.
The larger and more complex a clinical trial, the more potential pitfalls lie in wait for researchers. More data can mean more queries to resolve. As protocols become more complex, studies can face a higher risk of suffering from inefficiencies.3 Managing the regulatory paradigms of the various countries involved in international clinical trials can create administrative challenges and lead to delays.4 Clinical research, already a notoriously time-sensitive affair, can hardly afford these hurdles.
Whether EDC lessens or exacerbates these challenges can be determined as early as study configuration. Unfortunately, it’s too common for EDC alone to be incapable of providing the tools necessary for study build. As a result, users are often required to seek help from external programmers. This entails a long process involving numerous drafts of study specifications and a lot of back-and-forth between programmers and project managers. And of course, this doesn’t just take time – it creates extra costs as well.
However, while this is the norm, it’s not a necessity – fully in-house study build is indeed possible. Medrio users, for example, are able to cut programmers out of the equation and build their own studies using a simple drag-and-drop interface. This reins in timelines and costs, and keeps users fully in control of their own study build.
eClinical technology is a vibrant industry. Today, EDC is just one of an array of eClinical offerings that includes eSource, CTMS, IRT, and others. The more of these solutions enter the market, the more clinical trial-related tasks can go electronic, and that’s a good thing. The problem is that, too often, transferring data between these systems is a cumbersome manual process. The CenterWatch report cites the inability of these systems to communicate with one another as a major source of delays and other headaches.
Fortunately, if sponsors and CROs are meticulous in their vendor selection, there are eClinical solutions that will allow them to streamline the data transfer process. There are, for example, EDC offerings that can send form rules to eSource applications electronically, and eSource applications that can sync data directly with its associated EDC. And some EDC solutions provide APIs to integrate with other eClinical systems. Such functionalities allow researchers to access more of the technologies available today without unnecessary redundancies and inefficiencies.
Managing adaptive protocols
More and more researchers today are beginning to recognize the time and cost savings that can come from an adaptive approach to clinical trial design. Unfortunately, however, those savings can be negated by an EDC that can’t effectively accommodate an adaptive approach. If, in the event of a protocol change, an EDC requires users to pause their study and take the database offline to implement the change – which many EDC vendors do – researchers would be forgiven for wondering where the value is at the end of the day. To ensure their efforts aren’t in vain, sponsors and CROs pursuing adaptive trial design should ensure that their EDC makes it easy to make mid-study changes without interrupting, and thereby delaying, their studies.
Timelines are a consistent challenge in clinical research, one that can even, at times, give way to crisis. The wrong EDC, rather than helping to navigate this challenge, could end up throwing gasoline on the fire. For sponsors and CROs, the fundamental question for a potential vendor is: Will this tool actually reduce inefficiencies, or will it add to them? The right solutions are out there – it’s simply a matter of choosing wisely.
1 Li, Rebecca; Barnes, Mark; Aldinger, Carmen E.; Bierer, Barbara E.; Global Clinical Trials: Ethics, Harmonization and Commitments to Transparency; Harvard Public Health Review; 2015
2 Welch, Anna Rose; Patient Recruitment In An Age Of Clinical Trial Protocol Complexity; Clinical Leader; 21 August 2014
3 Morgan, Craig; The Need For Speed In Clinical Study Startup; Clinical Leader; 9 July 2015
4 Ndebele, Paul; Blanchard-Horan, Christina; Shahkolahi, Akbar; Sanne, Ian; Regulatory challenges associated with conducting multi-country clinical trials in resource-limited settings; U.S. National Library of Medicine; 1 January 2014