In recent decades, the advance of technology has enabled drug developers to move aspects of clinical trials from paper to electronic platforms. Now, Otsuka Pharmaceutical is looking to banish paper altogether by working to prepare a 100% e-platform for use in Phase III clinical trials.
The platform itself is already in place. As it stands, Otsuka is in the middle of putting the platform through its paces in a pilot program. In the pilot, everything from informed consent to the collection of patient reported outcomes is being handled by electronic technologies. Multiple drugmakers have used electronic tools for these processes, but Otsuka is notable for its ambition to move beyond just using some technologies in certain trials.
“We are now at the point where we are ... scaling up to large Phase III clinical trials on a complete e-platform,” Dr. Margaretta Nyilas, SVP of clinical management and business operations at Otsuka, told FierceBiotechIT.
This task is likely to prove challenging. The trial piloting the e-platform has worked with a small number of sites. Otsuka wants to use the platform in studies that work with hundreds of sites in multiple countries to enroll tens of thousands of patients. Nyilas acknowledges that going from the pilot to full-scale use will force Otsuka to address a series of barriers.
“It's not that easy. Even just scaling up, for example, the implementation of e-consent and e-source in a large multinational clinical trial requires a lot of adaptation on a country by country basis, language, regulations, etc,” Nyilas said. Otsuka will also have to train site staff, who will have varying degrees of technological proficiency, on how they and the subjects they enroll will need to use the e-platform.
If Otsuka is to succeed, it will initially require a lot more work before the trials begin. This will be needed to get everyone, from internal teams to sites to IRBs, comfortable with the platform. Achieving this across, say, 100 trial sites in 10 countries represents a tough task.
Much of the technology needed to create a 100% e-platform has existed for years. What has been lacking, and is still lacking, is the adaptation of the tools to each scenario they will face and experience of using them among the various members of the clinical trial ecosystem. Otsuka will have to address these issues.
Otsuka thinks the potential benefits of finally cutting ties to paper will justify the time and resources this takes. Nyilas foresees the platform helping Otsuka in multiple ways, one of which relates to its ability to cut the time it takes for study teams to access data. With Otsuka aspiring to provide real-time access to data relating to processes such as the inclusion/exclusion step, Nyilas thinks the speed at which study teams can answer questions and adapt mid-trial will increase.
“What are the roadblocks in terms of the patient journey throughout the trial, what are the roadblocks for the investigator in terms of handling certain situations with the patients and what are the opportunities in terms of improving the clinical trial process in general?” Nyilas said as examples of the types of questions real-time data will help to answer faster.
The ultimate ambition is to cut the time it takes to get a trial up and running and, in doing so, shorten overall study timelines. This ambition extends to the last step in the trial process.
“Our current goal for this year is a 72 hour database lock,” Nyilas said.