IDENTIFYING THE ROOT CAUSE OF A LOW RECRUITMENT RATE ANDREVERSING THE TREND
- cc9508
- Mar 5
- 2 min read
Updated: Mar 6
Dose-escalation phase I/II study in patients with glioblastoma
PRODUCT TYPE
Small molecule
THERAPEUTIC AREA
Oncology – solid tumours
ILIFE CONSULTING SERVICES
Clinical trial and clinical operations gap analysis
BACKGROUND
The Sponsor, a listed biotechnology company focused on improving cancer treatment by targeting the tumor microenvironment was initiating a key phase I/II clinical trial in the midst of the pandemic crisis. Having suffered multiple hurdles, and to avoid the negative impacts of any delays, the Sponsor proactively decided to have the study procedures reviewed by an outside party in order to point out any potential source of dysfunction so as to take appropriate pre-emptive remedy actions.
CHALLENGES
Performing an operational gap analysis is never a simple task, particularly when evaluating individual or team performances, and pondering on personal attributes such as task competency, performance level, and productivity. At ILife Consulting, we aim to approach such missions with tact and diplomacy for better buy-in. The broad and deep experience of the ILife Consulting team in clinical trial management and operations gives it the ability to assess and quickly apprehend all the parameters of a clinical study, thus
Ensuring that project requirements are being met
Finding areas of weakness and shortcomings to address
Uncovering differences in perception
Providing information to guide management, leading to better-informed decision making
Finding the best areas to deploy resources and focus energy
Prioritizing needs
OBJECTIVES
The Sponsor wished to improve communication with the CROs and investigator sites involved in its clinical study to ultimately improve recruitment rates as well as the timing and quality of the information flow.
ILife Consulting had the opportunity to suggest more efficient, value-adding methodologies to its clients.
SOLUTIONS
ILife Consulting suggested a gap analysis of:
• The responsibilities, management and interactions between the Sponsor, the CRO in charge of Project Management and Monitoring activities, and the central image analysis vendor,
• The communication flow between the Sponsor, the CROs and the investigator sites and escalation process
• The reporting tools regarding the study status After reviewing a number of essential documents, ILC performed a series of face-to-face interviews with the Sponsor ‘s clinical operation team members
ILife Consulting conducted a clinical gap analysis on the clinical study conduct, and on the interactions between the Sponsor’s clinical team and different parties
Review of roles and responsibilities
ILC proposed and implemented corrective and preventive actions
Through strategic recommendations—including site closure and vendor realignment—ILife Consulting optimized study execution, improved recruitment strategies, and strengthened Sponsor confidence
ILife Consulting fostered strong collaboration between the Sponsor, CROs, and investigator sites by improving communication flows and aligning expectations, ensuring smoother clinical trial operations.
RESULTS
ILife Consulting conducted a clinical gap analysis that highlighted strong communication between the Sponsor and investigator sites, as well as effective study oversight. However, the analysis uncovered challenges, including recruitment strategy issues due to drug shortages and a lack of clarity in vendor roles and responsibilities.
Key recommendations included closing a non-recruiting site to reduce costs and re-aligning expectations and timelines with vendors. Through this process, ILife Consulting earned the Sponsor’s trust, leading to further collaboration on operational improvements. The findings emphasized the need for enhanced internal and external communication and streamlined project management to optimize study execution.