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!
