A Study That Tested Both Operations and Team Resilience
Some studies challenge you not only operationally, but also as a research team. This integrated Phase Ib/2a trial in genital herpes has been one of them.
From the beginning, we understood that success in this study would depend on much more than meeting timelines or executing procedures correctly. It would require scientific rigor, regulatory discipline, and a genuinely patient-centered approach in an indication where privacy, trust, and sensitivity matter enormously.
So far, the study has confirmed exactly that.
Recruitment Challenges in a Sensitive Indication
One of the earliest realities we had to address was recruitment. In genital herpes, identifying eligible patients is only part of the challenge. Reaching them is often the harder part. Many people living with this condition are understandably hesitant to engage. Stigma, embarrassment, and concern about confidentiality can all become barriers long before a patient is ever screened.
That is why we knew a conventional recruitment model would not be enough. We applied 9 different outreach approaches to broaden access and create a more resilient recruitment pathway.
Recruitment Outcomes
As a result, we identified more than 320 potential participants, screened 142, and enrolled and randomized 72 patients over a six-month period.
These numbers matter to us not simply because they reflect performance, but because they reflect process. In a study with restrictive inclusion and exclusion criteria, recruitment quality is just as important as recruitment volume. It is not enough to generate interest. You need to identify the right patients, screen carefully, and move forward without compromising protocol integrity. That balance has been central to our work throughout this program.
Participant Retention and Engagement
Retention has been just as important.
The Phase Ib portion of the study placed a significant burden on participants, particularly those required to remain at Convex Clinical Trials Center for 24-hour pharmacokinetic assessments. That level of commitment asks a great deal from patients.
In our experience, that kind of retention is never achieved through logistics alone. It depends on how patients feel throughout the study. Are they informed? Are they treated with respect? Do they understand why each procedure matters? Do they feel that the team is fully present and invested in their experience?
Those questions are not peripheral to trial delivery. They are part of trial delivery. In this study, clear communication, thoughtful coordination, and consistent support have made a meaningful difference in helping patients stay engaged, even during the more demanding parts of the protocol.
Operational Discipline and Trial Management
From an operational standpoint, this trial has also required a high level of discipline across startup, regulatory readiness, protocol execution, sample handling, and safety oversight. We met all predefined timelines and achieved all major milestones as planned. That level of consistency is especially important in early-phase research, where the quality of execution has a direct impact on both data integrity and participant safety.
The Complexity of Integrated Studies
Integrated studies bring their own complexity. The demands of Phase Ib and Phase 2a are related, but they are not the same. Phase Ib requires close monitoring, intensive procedures, and tight procedural control. Phase 2a introduces a different kind of pressure: more patients, faster timelines, and a greater need for operational scale without sacrificing quality.
Moving into the Next Phase
We are now moving fully into Phase 2a with exactly that understanding. The pace is increasing, the timelines are shorter, and the expectations remain high. But the work completed so far has created a strong foundation for this next stage.
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