Looking at the future of regulation, Henrik turned to Alan to better understand the results of new EMA guidelines for computerised systems and their impact on issues such as data management and eConsent. Together they discussed regulatory trends and how they might impact clinical trials moving forward. Watch the video, or read the article below.
In 2021, the EMA released a draft of guidelines for users of computerized systems in clinical trials. Following a period of review, the guidelines are expected to be published in 2022. The nearly 50-page report will be the first of its kind; a comprehensive collection of current and relevant information dedicated entirely to regulatory requirements and the use of computerized systems. The report will cover everything from eSource, clinical data requirements and storage – to newer tools like ePRO, eTMF and eConsent. The report will also address how trials are regulated and highlight the advantages of modern data management systems and tools when used in the most efficient way. As Alan points out, the report is unique both in terms of its practicality and relevance;
- Previously, you had to search for all of this knowledge yourself. Now it's all in one document for the first time.
As Henrik and Alan discussed the coming guidelines, it became clear that industry needs are driving certain trends, and in turn, the development of important new regulatory services and tools.
The topic of archiving and decommissioning computerized systems used in clinical trials came under closer scrutiny a few years ago. At that time, Alan was invited to London to attend EMA discussions as an industry representative and work together with fellow companies and members of eClinical forum, EUCROF, the EU CRO Federation, to name just a few. They formed a team of 20 experts from within the industry, and Alan was invited to chair the group. Together, they produced a paper about best practices and use of TMFs, as well as how to decommission computerised systems, so that relevant data could be strategically distributed, stored and appropriately shared with sponsors, sites and vendors. Sponsors and the sites need information that's important for the TMF, but not trial specific, while the needs for vendors are, of course, quite different. Their goal was to make the overall process more efficient for each actor.
Storage of data and how long to keep it was another important topic the paper addressed. Decommissioning computerized systems, when trials can stop saving data and required retention periods, have been under review as well, and as of January 2022, the EU's clinical trial regulation will require all relevant data to be saved for at least 25 years. This could be cumbersome, of course, but with the help of Viedoc, all relevant data can be exported and saved, including all associated metadata and audit trails, so that "decommission" can take place.
With increasing pressure in recent years, regulatory authorities have been pushing for evidence that sponsors and their CROs are performing audit trail reviews throughout their trials. As Alan explains, solutions for this are increasingly in development and available;
- This is something we addressed in a paper produced by the eClinical Forum examining what we need to look at in an audit trail review. And we used that when we produced our latest reports in Viedoc Reports. We've got detailed visual reports at both country, regional and site level, and we've defined key performance indicators, so that you can look at trends throughout your trial. Things like the time required to enter data and answer queries, how many data changes are made, and the occurrence or lack of patient safety events help determine how your different sites are performing in the trial and which sites may need a little more attention.
Backwards compatibility is an important aspect for any supplier of cloud services, and Viedoc realised very early on that backwards compatibility was extremely important. Whenever they release a new version of Viedoc, it affects anyone in the midst an ongoing trial, and their position is that the impact should be invisible. It should not place new demands on a trial, and it shouldn't change the validation status of the trial setup. In essence, everything should be the same before as well as after a new release.
"We put a lot of pride into that," Alan explains. A core issue for Viedoc is that you should not be troubled by releases. And this includes the user interface. Of course, minor cosmetic changes might occur, but even in the instance of minor changes, Viedoc might choose additional training, so that all the users are familiar with the new look and feel before it's ever released into the study.
Naturally, this means that a service company like Viedoc must carefully consider what is released or not. Even seemingly slight changes, like new functions that appear useful at first glance, must be measured against their backwards compatibility.
As eConsent gains wider acceptance and country after country adapt their laws to allow electronic signatures, interest in eConsent is accelerating. eConsent is, however, much more than just a signature. Signature is one aspect, and views on e-signatures vary greatly from one culture and country to the next. But there are other aspects related to consent, including how data is presented to patients and how interviews between investigators, site staff and subjects are conducted. Subjects must be tested to ensure that they understand what's going on and fully grasp the information that's been presented to them, and this can require identity confirmation. If this is going to be increasingly done locally and remotely, as was seen during the pandemic's first year, eConsent's role could become more important.
Henrik, Viedoc's COO, explains that eConsent is often seen as the final step, when a patient signs off on their consent form. By using a drawing pad, such as the one Viedoc is introducing, patients will be able to use nothing more than a finger to provide their signature or check a checkbox marked 'I hereby confirm. And with Viedoc’s ePRO and Telemedicine services, usernames, pin codes and secure video calls could ensure secure identities. And while there is no single standard solution for all countries, a hybrid approach could provide increasing efficiency and ease.
As a Regulatory Affairs Manager, Alan works through international industry groups, such as eClinical Forum – an international group with participants in North America, Europe, and Asia Pacific. Other groups include EUCROF, the EU CRO Federation, which cover the EU, and RQA, originally British Association for Research Quality Assurance, and ACDM, the Association for Clinical Data Management. In his work with these different groups, a lot of interaction with regulatory authorities takes place, and to date, the focus of this cooperation has been computerized systems. But in recent years, new areas have become increasingly relevant, such as the role of artificial intelligence in clinical research, and Big Data, a topic Alan is invited to speak on in order to address data quality and representativeness. Alan explains;
- I think it's thrilling to actually talk to the people who are looking at these topics, and it's good for us as well. We get to check directly with the authorities about whether the way we're doing things is what they expect – or not. And in doing so, we get to represent our customers as well. I've had customers ask me questions, and I've been able to personally go to the authorities and take those concerns up with them.
As society evolves and technology opens new doors, clinical trials face inevitable change. But with new forms of collaboration and a mindset of opportunity, services and tools can be developed to pave the way for more sophisticated regulation, driving the development of more effective medicines and better working methods to create them.
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