Pressure test your study before you start.
Source: Impact Report (2014) Tufts CSDD1/5 of Phase II protocols and 1/3 of Phase III protocols collect non-core data that’s irrelevant to the study’s goals and requirements.
Case Study:
Revising a Global Phase II Study
Situation
A mid-size pharma company was finalizing a protocol for a Phase II study in non-small lung cancer.
IQVIA Action
We performed an analytics-based review of the protocol, identifying two design decisions that increased study risk: 1) neither of the co-primary endpoints were similar to comparable trials for this indication, and 2) this protocol included more and different QoL/PRO measurements.
In addition, we identified a design inconsistency: a missing PK/Antidrug antibody schedule for the comparative arm.
Customer Result
By revising the protocol to include the missing schedule, the customer avoided risk of protocol deviations, missing data and budget overruns. Also, the primary endpoint was changed to better align with comparable NSCLC trials, potentially mitigating regulatory risks.
Apply real world data to your trial with nonidentified data from more than 500 million patients across eight countries using pre-built analytics.
Leverage a global network of Phase I clinical pharmacology units to build diversity in patient populations and access a range of geographic regions for early clinical development (ECD) programs.
Improve the performance of your clinical trials with the power of the IQVIA CORE.
Identify the best performing sites for your trial in less time with new machine learning and predictive modeling methods.
Access central labs around the globe through Q² Solutions, a joint venture between IQVIA and Quest Diagnostics.