Enrolling a Rare Ovarian Cancer Trial 2 Years Ahead of Schedule

At a Glance

The sponsor of a Phase 2 trial in rare ovarian tumors knew enrolling on time with an exceedingly small patient population and a wide global spread would be challenging. PSI worked with the sponsor and leveraged our strong site relationships around the globe, to not only meet but exceed enrollment goals. Ultimately, we supported the sponsor by completing enrollment in nine months, more than two years ahead of schedule, and enrolling ten more patients than initially planned.

enrollment graph with red and blue lines

Phase 2 Rare Ovarian Cancer Study

Sponsor Challenges

As with many rare disease trials, one of the greatest challenges was that there had never been a study that enrolled this specific population, and epidemiology data was likewise scarce. There is also a high administrative burden for rare disease trials that are slow to enroll; locating enthusiastic investigators who will stay motivated throughout the trial is vitally important.

PSI Strategy

1) Finding the right sites and patients

PSI turned to our network of more than 4,000 oncology sites, and positive working relationships with investigators active in gynecological cancer research around the world. This allowed us to identify the ideal sites with a high volume of ovarian cancer patients and key opinion leaders specializing in rare ovarian tumors. Many of these centers met our ideal site profile, as the sites are large institutions that see a high flow of ovarian cancer patients. The data from other countries was perfectly acceptable.

2) The value of site relationships

Because our CRAs understand each site’s organizational structure and can anticipate their needs, PSI was able to provide tailored site support to ensure consistent enrollment. In order to screen and enroll every patient possible, our team worked with the investigators to track and monitor patients with eligible criteria, so that upon relapse, patients could be screened for potential entry into the study.

3) Every patient counts

Enrollment was often a literal race against time. A last-minute eligible patient was scheduled to travel to a site to enroll in the study, but the IRB (Institutional Review Board) required additional changes to the ICF (Informed Consent Form) for this particular study the day before the patient’s arrival. The team was able to get the consent language finalized and resubmitted the same day. The approval came in the day of the patient’s arrival, and PSI worked simultaneously with the sponsor to get the IP-RED approved in time.


  • 25% more patients enrolled than targeted
  • LPI achieved in 9 months
  • Enrollment completed 2 years ahead of schedule

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