Successfully conducting a clinical trial to completion is rarely a straightforward and stress-free process. Regulatory approval, often from multiple jurisdictions, must be obtained, qualified patients must be recruited, and medical supplies must be both secured and distributed within strict timelines. If a mistake is made, then the success of the whole trial could be put in jeopardy.
Further complexity happens when, in a blind study, the patients cannot know what treatment program they are on. In addition, in a double-blind study, the researchers must also be kept in the dark. With all this considered, the potential for a procedural stumbling block to become an impasse is a real possibility.
Interactive Response Technology (IRT) systems are the administrative and logistical frameworks designed to minimize the risk of such errors or miscalculations by managing and tracking essential services such as patient randomization and the dispensing of drugs.
The construction of the system must begin with an in-depth consultation with those running the trial to understand their protocol in detail so the system is configured to fit specific requirements. However, because clinical trials increase in complexity and face a myriad of unknowns, it is critical to ensure that the technology itself has the capability to respond quickly to unexpected scenarios.
“It starts with ensuring we have a deep and clear understanding of the client’s protocol and knowing what their challenges are so we can tailor their system to their specific needs,” explains John Ristuccia, senior vice-president of global client services at Suvoda.
However, even the most carefully constructed trial protocol will require changes over the course of a trial’s lifetime, especially in the case of complex trials. According to a January/2022年2月 Impact Report by The Tufts Center for Study of Drug Development1, the highest number of significant amendments occur in phase II and III oncology trials. This is a key reason why any trial IRT system must have significant, built-in flexibility.
Challenges and change are inherent to running a trial
For evidence of the inherent nature of change, consider the restrictions put in place worldwide to slow the spread of Covid-19. Covid-19 forced clinical trial teams with trials already underway in clinical settings, to transition to a direct-to-patient mode of operation. This was especially challenging for global clinical trials, as regulations, lockdowns, and enrollment rates differed across nations.
“A lot happens over the course of a study,” says Ristuccia. “You don’t just implement an IRT system and then let it run for the next two or three years. You’re going to have protocol amendments, you’re going to have challenges with supply, and you’re going to have events like the Covid pandemic that turn everything upside down.”
When unforeseen events happen, you need to shift quickly. This is when it’s critical to have expert support from an IRT team that has an in-depth understanding of your trial, as well as an IRT system built to handle the unexpected.
“If you’re not able to randomize new patients into a trial or dispense patient medications, or the right drug isn’t getting to the sites, it causes major, real-world impacts that delay trials,” explains Rob Hummel, chief operating officer at Suvoda. “So when it’s not working it can be a huge problem for sponsors.”
Suvoda’s issue analysis found that specialized issues make up the bulk of the service requests that they receive from clients. The study revealed that 80% of client requests are protocol-specific rather than simple user requests.
This means that the IRT system must be flexible and aligned to the nuances of the protocol so alterations can easily be made mid-trial. In order to do this, the staff supporting the system needs to possess an in-depth understanding of the protocol and system design to enable making changes quickly and minimizing trial delays.
“It’s not something where any service team could just glance at the user interface in the software and know exactly what to do,” explains Ristuccia. “Our staff have to remain calm under pressure because a client might be on-site with a patient. With their experience and knowledge, our support teams can drill into the trial data, assess it, and then resolve it within a reasonable timeframe.”
At Suvoda, understanding the finer points of every client trial and its objectives is critical. Suvoda has specialized cross-functional teams that work closely with Suvoda’s customers throughout the life of a trial. This supports each client so that as the trial progresses, the team’s knowledge and understanding progresses as well. It positions the team to respond quickly, should a modification need to be made to the protocol following regulatory feedback, for example. A specialized team also supports trial professionals by offering perspective on best practices seen from client trends such as deploying a direct-to-patient strategy.
“It’s critical for us to be prepared to support the customer or the sponsor and the sites throughout the course of the trial to keep the trial on track,” adds Ristuccia. “That means having the right people and processes in place, as well as the right technology that can adapt to their needs over time.”
With 70% of the clinical trials conducted by Suvoda relating to complex therapeutic areas such as oncology, the central nervous system or other rare diseases, the fact that each member of Suvoda’s IRT support team has experience working on such trials is key to ensuring exceptional service and giving trials the best chance of success.
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(Reposted with permission from Clinical Trials Arena)