Protocol Design

Pressure test your study before you start.

Using real world data and advanced analytics, experts from IQVIA can proactively identify issues in your clinical trial design.

Solutions Research & Development Clinical Trials Protocol Design

Reduce the risk of amendments and delays

When you are investing millions in developing a new drug, finding hidden costs before they become real problems is mission-critical.

IQVIA offers a systematic approach integrating advanced analytics, therapeutic expertise and real world data that can substantially improve planning, feasibility and enrollment targets. Sources include

Electronic medical records
Clinical research data
Public data sources
Industry benchmarks

This approach allows you to develop or optimize a protocol design to deliver the right data from the start, without unexpected issues or unnecessary costs.

Whitepaper

How Clinical Trial Design Impacts Enrollment of Diverse Populations

Does motivation to enroll in a study vary by race and ethnicity?

Feb 02, 2023

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Control costs and avoid potential roadblocks

Whether you’re in the process or have already developed your study protocol, IQVIA can ‘pressure-test’ it using real world data to check for precision, clarity and consistency, including

Testing for patient and site burden to identify barriers to patient recruitment and retention
Identifying non-core procedures so you can remove them to reduce study costs and complexity
Understanding competitors to benchmark design and enrollment strategies and maximize study value
Improving eligibility criteria to help recruit eligible patients and predict screen failure

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.