Indolent NHL Immuno-Oncology Rescue Study

Case Study

Background

Non-Hodgkin's Lymphoma

(Indolent NHL, PI3K inhibitor)

Allucent was contracted to provide rescue study services by a small-emerging biotech company after the originally contracted CRO had difficultly enrolling patients in the challenging indication of refractory, indolent NHL (Follicular Lymphoma, Marginal Zone Lymphoma, or Small Lymphocytic Lymphoma), as well as other quality issues.

Allucent set up additional sites in Western and Eastern Europe which kept enrolment on target. The sponsor later decided to hand over sites managed by the other CRO in Canada, UK, and the US.

Study Overview

  • Phase: II
  • Design: open label, single group
  • Study Population: 128 subjects
  • Services: regulatory (VHP submission), monitoring, project management, medical monitoring, data management
Country Sites Radomized Patients Patients/site/month
Belarus 4 10 0.22
Belgium 3 2 0.05
Bulgaria 4 5 0.11
Canada 3 9 0.11
Czecch Rep. 3 9 0.23
France 6 6 0.07
Georgia 2 1 0.04
Hungary 3 7 0.17
Italy 12 21 0.12
Spain 5 11 0.03
UK 8 11 0.10
US  35 45 0.05

 

Study Challenges & Solutions

Challenge #1

Identify quality sites and confirm enrolment estimates

With an indication that was particularly challenging to identify eligible patients Allucent needed to ensure sites had access to both a pool of potential patients, but also the means and resources to identify them in a timely manner.

Solution 

  1. Confirm sites possess available resources to search the database. Sites often have limited information in the searchable database as well, so patient identification can require significant manual work. In select cases, database search fees can support site motivation.
     
  2. Determine the distribution of hematologic malignancy indications at the site (PIs are often specialized for a specific indication (or subtype) and it is essential to identify site sub-Is that can complement support of all protocol indications.
     
  3. Identify competing studies as hematology oncology is a highly competitive market. With multiple trials at the same site, unrelated studies will still compete for resources.
     
  4. Determine if additional study coordinator fees or other incentives would be allowable to motivate sites that over enrol compared to the initial enrolment projection.

 

Challenge #2

Implement patient recruitment strategies to mitigate delayed timelines

The study required patients who are diagnosed with indolent NHL refractory to Rituximab and chemotherapy/radioimmunotherapy meaning identification was particularly challenging and required more intensive screening techniques to be applied to stay on schedule.

Solution

  1. Promote local competition (country level) through study newsletters or targeted emails to encourage performance compared to competing local PIs.
     
  2. Provide scheduled communication of study status through newsletters and newsflashes on the study level to encourage sharing of successes and best practices with all sites.
     
  3. Utilize motivational visits by CRAs and Medical Monitor or Sponsor representative – assessing the right timing and attendees to ensure engagement of correct stakeholders.
     
  4. If possible, organize meetings for the PIs with the Sponsor during regional conferences.

 

Challenge #3

Clinical Database Transfer

The original CRO contracted a third party to build the study database in an electronic database platform not previously used by the Allucent study team. Since the clinical database is a critical component in subject data collection and analysis, we knew the shift of responsibilities to Allucent had to be managed carefully, be transparent, seamless, and have no impact on enrolment and site interactions.

Solution

Allucent's Data Management Team engaged with the original clinical database developer immediately upon notification of rescue award to understand the steps to transfer ‘ownership’ from the originally contracted CRO to Allucent as quickly and efficiently as possible. With prior experience in rescue study database administration, we outlined a detailed transition plan to the sponsor, the study team, and prepared our Data Systems Designers to assume administrative responsibilities. Within a very short span of time, our Data Manager completed system administrator workflow training, updated older documentation to Allucent’s robust DMP template to outline study processes, and transitioned the clinical database over the weekend to a new website link without any enrolment delay or site downtime.