Phase 1 Ophthalmology: 6 Key Elements for a Successful Trial at your Clinical Site

WCCT has extensive experience conducting Phase 1 Trials in ophthalmology, so we’d like to
provide some considerations for conducting a successful trial at your clinical site. Our experts
have collaborated to hone a list of issues that address the most crucial elements, and we’ve
compiled them below to highlight the key factors and strategies we’ve found to be essential for a
highly functional Phase 1 trial.

1. Initial Patient/Volunteer Education: “Patient information and education is one of the
most crucial components of a successful trial. It is important to ensure that at the first
screening visit, prior to signing informed consent, all information regarding the trial and
volunteer expectations have been discussed in a clear, detailed manner. A research
participant is most compliant when they understand and are aware of their
responsibilities during their time in the trial.” – Dr. Sherif El-Harazi, President and
Research Investigator at Global Research Management and ophthalmic consultant to
WCCT.

2. Volunteer Scheduling and Site Staffing: We’ve found scheduling and staffing to be
crucial for a trial to run smoothly from start to finish. Prepping for in-unit and outpatient
visits to reduce trial participant wait time and exploring ways to make their wait time
more enjoyable can eliminate common stressors associated with clinical trials. In
Healthy Volunteer trials, we recommend splitting the screening visit if both lab and eye
assessments are required, which helps reduce costs associated with conducting exams
on volunteers who may not qualify based on initial lab results. It’s also important to
schedule transportation accommodations for situations where volunteers will be unable
to drive post-appointment due to assessments that could impair vision.

3. Ocular Assessments in Healthy Volunteers: The enrollment of “normal” subjects from
a typical Phase 1 Unit database does not necessarily correlate to them having normal
eyes, so we recommend developing a clear plan for identifying volunteers who do have
normal eyes. Thorough prescreening, planning for higher Screen Failure rates, and
establishing a database of “normal eye” volunteers can all help reduce time and costs.

4. Volunteer Training: Study participants in ophthalmology Phase 1 Trials often require
additional training once they have agreed to enroll in a study. Proper training in dose
administration (when applicable), diary completion for home dosing, and instructions on
ocular assessments can all reduce complications that often come with volunteer lapses.
We recommend having trial volunteers demonstrate capability to self-dose as a requisite
for enrollment, and we highly recommend providing thorough instructions for proper
documentation in volunteer diary cards, highlighting the fact that volunteer non-
compliance can lead to their early termination from participation and/or non-evaluable
data.

5. Logistics Management: While late phase trials generally allow researchers to collect
data points at any time of the study visit, Phase 1 trials need strict adherence to dosing
times and post-dose serial procedures. Several variables often effect the timing of eye
procedures, so it’s especially important to make logistical considerations for larger
groups of volunteers that enroll in a “block” or “cohort” fashion in Phase 1 trials. Enrolling
a high number of participants increases the chances of having overlapping procedure
times, which can necessitate more procedure rooms, equipment, and staffing. It is
important for the clinical site to carefully assess the stagger of dosing times to find the
most efficient way to enroll a large cohort of volunteers. Overall, being prepared for the
unknown and having well-evaluated backup plans can help eliminate the risk of losing
volunteer compliance and efficiency.

6. FDA Compliance: Ensuring FDA compliance is embedded within all methodology is an
often-overlooked aspect of conducting efficient trials, but should always be the first and
last consideration. It’s crucial to ensure that all endpoints are using FDA-confirmed
methods of data capture, and that all sites and investigators are conducting procedures
in a standardized way.

WCCT will be attending ARVO 2019 from April 28 – May 1, where we’ll be collaborating with
others in attendance to share valuable insights for clinical research in ophthalmology.

If you’ll be in attendance, please contact us to set up a meeting time at our exhibit (Booth 1550).