BICR in New Therapeutic Lung Cancer Trials

NCT05038826 | Completed

• 1 other identifier: Median202101
• Study Type: observational
• Target: 1,833
• Locations: 1 country
• Sites: 1

Brief Summary

Double reads in blinded independent central reviews (BICRs) are recommended to control the quality of trials but they are prone to discordances. We analyzed inter-reader discordances in a pool of lung cancer trials using RECIST 1.1.

Conditions

Lung Cancer

Keywords

blinded independent central review; RECIST1.1

Outcome Measures

Primary Outcomes (1)

• inter-reader discordance rate

  1. Based on the Response Evaluation in Solid Tumors (RECIST), inter-reader discordance rate considering any discordances at any time point: Number of discrepant time points / Total number of time point 2. Based on the Response Evaluation in Solid Tumors (RECIST), inter-reader discordance rate considering any discordances at any time point: Number of patients with, at least, one discrepant time point/ Total number of patients 3. Based on the Response Evaluation in Solid Tumors (RECIST), inter-reader discordance rate in reporting, at least, one progressive disease at any time point: Number of patients with, at least, one discrepant time point on PD / Total number of patients

  6 months

Secondary Outcomes (4)

• endorsement rate

  6 months

• adjudication rationale

  6 months

• Correlation between discrepancy rate and timepoints

  6 months

• root cause

  6 months

Study Arms (6)

trial 1

Immune checkpoints + chemotherapy vs. chemotherapy + placebo

trial 2

Immune checkpoints + chemotherapy vs. chemotherapy + placebo

trial 3

RNA-polymerase-II inhibitor

trial 4

Tyrosine kinases inhibitor

trial 5

Tyrosine kinases inhibitor

trial 6

Immune checkpoints + chemotherapy vs. chemotherapy + placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient diagnosed with lung cancer and included in a clinical trial between 2017 and 2021. Assessments of read discordance are part of the quality program that tracks any inherent reader variability. Monitoring processes usually rely on several read performance KPIs, including the inter-reader discordance rate, the adjudication rate, the endorsement rate, and the error rate used to identify reader outliers. The adjudicator and the medical monitor document every discrepancy event along with the possible root causes, which here included four RECIST-derived categories along with two operationally based causes. These discordances were also categorized ac-cording to the type of expected discordance: "read error" or "medically justifiable difference".

You may qualify if:

• patient diagnosed with lung cancer and included in a clinical trial between 2017 and 2021
• trials were conducted with double reads with adjudication, and assessments were based on RECIST 1.1 guidelines
• The central reads performed using the same radiological reading platform (LMS; Median Technologies, France)

You may not qualify if:

• reader evaluation with less than 25 adjudications

Sponsors & Collaborators

• Median Technologies: lead

Study Sites (1)

Yan Liu

Valbonne, 06560, France

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: September 9, 2021
• Study Start: February 1, 2021
• Primary Completion: August 10, 2021
• Study Completion: December 1, 2021
• Last Updated: March 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)