The annual CDISC US Interchange conference is an opportunity for PROMETRIKA’s Statistical Programming team to learn about the newest ideas and trends for data dissemination in the industry. At this year’s gathering, between the keynote speaker’s sentiments, the FDA’s opening thoughts, and the breakout sessions – one idea carried through each talk; how do we increase communication and collaboration across all functions to make everyone’s life easier and reduce the work load placed on all involved – from Sponsors to CROs to the FDA to patients?
The Keynote Presentation kicked off the conference with those themes. Many in the industry hope to see clinical care and clinical research merge, reducing the burden on all involved, into one clinical appointment rather than two separate appointments (usual care or trial assessments), with different needs. This idea was largely focused around the ‘post-COVID’ world we find ourselves in – where, for example, some assessments can be carried out remotely and wearable devices are more and more popular. The idea also built on how to get regulatory-quality metrics during regular clinical care and scale those interactions. Much of this hope is reliant on modernizing clinical trials and the ways in which we acquire data.
One of the greatest road blocks in clinical trials is recruitment- at present, 40% to 50% of patients evaluated are screen failures and only 45% of eligible patients actually make it into the trial. With so many trials focusing on indications with small patient populations, recruitment challenges can greatly impact the feasibility of carrying out trials. There needs to be more open communication between sponsors and sites at the outset regarding expectations, such as the schedule of activities, so that patients and providers can assess feasibility more accurately.
The FDA also faces challenges due to the volume of data presented electronically in today’s submissions. A discussion of submission modernization from the FDA focused on the idea of submissions at a high level and hopes for the future; particularly focusing on how submissions could be managed when being submitted to multiple global agencies. While there are no longer truckloads of papers being delivered to the FDA’s door daily, the digital ‘paper’ load is the same as in the past, if not worse, due to the ease of transmitting data electronically. This creates an extreme amount of work at FDA to unpack this load of digital paperwork, garner what is needed, and determine what was extra – for example cover letters are not needed by data reviewers. A lack of central communication is another stress point for the FDA. These stressors are all technically avoidable at this point in time but remain challenges due to a need for modernization.
An example given at the conference was that there is no communication across global regulatory agencies. When one agency asks a sponsor for additional documentation, other agencies are not aware of the request and then may separately ask the sponsor for those same additional materials. In this instance, there is duplicate work being placed on the sponsor. While resolution of this and other issues may be far in the future, one idea of centralizing how data is sent to regulatory agencies was discussed – potentially creating a centralized repository to which all involved agencies are given access to all materials. In a system like this, if one agency requested extra materials, those materials would be posted to the central repository. At any time, should another agency also need those materials, they would be able to pull them directly from the repository without needing to ask the sponsor to repeat that additional work.
While many of the breakout sessions continued focusing on these themes, another that garnered a lot of discussion and thought was the active Git repository of open-source code for clinical trials. While all sponsors aim to profit at the end of their clinical research, the motivation of all involved in the industry is to improve patient lives and outcomes. Many companies and programmers have donated their time to work on code-sharing systems with that goal in mind. Some companies and programmers are already uploading some of their internal tools to a repository for public use so that other teams may adapt and utilize these tools in the interest of providing the most efficient care and results for patients. This kind of collaboration is rare in the industry and the current repository is a model example of the value of shared coding solutions. While so many other sessions focused on cross-departmental communication within a company, this discussion focused on broader communication and collaboration across the field.
The bottom-line question, after much discussion, was – why? There were some tough questions from the audience. One audience member asked, “What is the incentive for my company to help others when we are supposed to be working to make our bottom line the best that it can be?” This question has resonated with me for some time, and it comes down to two main ideas, in my opinion. The first is largely similar to the founding principles discussed above – ideally, all involved in clinical trial research, top to bottom, should be working to serve the interests of patients and patient care. While bottom lines are important, it is more important to modernize and communicate if that is what will advance the industry as a whole and provide better outcomes to all. Jumping off of that point is my second thought – an industry needs to work hard to overcome short sighted gains at the expense of long-term gains. While in the short term, keeping all material private and proprietary will likely serve a company’s own bottom line, it prevents greater developments and advancements. Putting time and effort into collaborative tools such as those discussed at the conference could raise the bottom line of one sponsor, while also raising the bottom lines of others. If a company works in their own self-interest, while others collaborate and innovate, it may serve the first company in the short term but, ultimately, they could find themselves playing catch up, if not left behind entirely.
It was exciting to have attended CDISC US Interchange and participate in these stimulating and thought-provoking discussions. I’m looking forward to reviewing and advancing some of these ideas with our team as PROMETRIKA works to continually improve data acquisition and submission processes for our sponsors.
