Faster Trials – Unlocking Speed in the Early Phases – A Look at Phase I
Speed and efficiency are always the goal in any trial phase, but it can be particularly challenging to control in Phase I, particularly for specialized groups like healthy elderly volunteers, cohorts that require extended dosing for multiple weeks, and Phase Ib designs conducted in patient populations. Even very small cohorts can be hard to come by when a Phase I design requires participants to be confined to a Phase I unit or attend daily study visits to receive the drug. External factors such as the COVID-19 pandemic have exacerbated the problem, as some Phase I clinics have paused enrollment, and healthy volunteers have even more reason to not want to spend a lot of time in healthcare facilities.
3 Steps for Speed in Phase I
1. Throw out the “This is the Way We’ve Always Done It” Mindset
While the clinical trial industry has increasingly adopted new technologies in Phase II – IV trials in recent years, many sponsors have not considered opportunities for innovation in Phase I. Many sponsors are so used to conducting Phase I trials using the same designs over and over that they fall into an “It is what it is,” attitude. Just because something is familiar, doesn’t mean that there isn’t room for improvement. With a backlog of molecules waiting to enter and complete Phase I testing due to trial delays during the COVID-19 pandemic, there have never been more reasons to adopt new ways of doing things. With technology available that can make trials in all phases run more quickly and smoothly, we no longer need to accept the status quo.
2. Optimize Site Selection
It’s no secret that some sites are better equipped to run particular clinical trials than others. When recruiting for specialized cohorts, look for sites that have access to patients that fit your study’s desired profile. Also, seek out sites that are further along in terms of their use of technology to help manage and monitor patients and are willing to work as a partner in adoption of innovative technologies to optimize your trial. Picking the sites that are best suited for your study puts you in a position to move through Phase I much more quickly.
3. Reduce the Need for In-Person Visits
While the initial single- and multiple-ascending dose cohorts of Phase I trials typically must be conducted in an inpatient setting, this isn’t necessarily the case for all Phase I designs. Many clinical development plans require additional patient cohorts before progressing to Phase II, or to generate required data sets later in the clinical development process. Sponsors may be required to enroll healthy elderly volunteers, conduct drug-drug interaction studies, or enroll healthy adults for longer exposures; weeks, or even months in some cases. To ensure data integrity, it is critical to ensure that all doses of the study drug have been taken – many sponsors confine patients for the entire trial duration, or require daily clinic visits for dosing in order to ensure the study drug has been taken. While it may be easy to identify potential trial participants who meet the Inclusion/ Exclusion criteria on paper, it can be prohibitively challenging to find people who are willing to stay in a Phase I unit for weeks at a time, or attend daily clinic visits for observed dosing.
Remote technology helps patients and sites to stay engaged 24/7, and provides complete visibility for sites and sponsors. Using the AiCure Patient Connect app, sponsors can generate an accurate record of when every dose has been taken, without the need to have it observed and recorded in a CRF. Additional relevant information, including meal times, targeted side effect questionnaires and other information relevant to understanding the drug’s profile, can be collected through ePRO questionnaires in the same interface. This flexibility provides many opportunities to re-think the same-old protocol design. For example, in a drug that takes two weeks to reach steady-state, after randomization patients could dose at home from days 1-13, with a single overnight stay for intensive PK sampling and other testing on day 14. Such a simple design modification substantially reduces the sponsor’s inpatient confinement costs and opens up the group of volunteers who might be willing to participate in a study requiring one or two overnight stays, compared to staying in an inpatient unit or coming to the clinic every day for multiple weeks.
With real-time information on every participant, sites can better use their resources and provide the right level of support for each participant and ensure high-quality data collection.
The Need for Speed – You Can Make It Happen
COVID-19 is accelerating change and necessitating the adoption of technology across the clinical development spectrum. Robust, compliant platforms allow us to engage with patients outside the clinic environment and the time has never been better to put these solutions to work in all trial phases. You don’t have to accept out of hand that Phase I has to be slow. The same technologies that are allowing you to keep your trials moving – and start new trials – during COVID-19 can be utilized to help accelerate your Phase I, facilitating patient recruitment and minimizing inpatient costs.
For more information on how you can implement AiCure in your Phase I trials, click here!