Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

In the past decade, the lung cancer treatment landscape has dramatically evolved, increasingly branching out thanks to better understanding of disease mechanisms of action, novel technologies, and some amount of serendipity in drug development. Today, approximately 2500 clinical trials registered on clinicaltrial.gov are about to recruit or are actively recruiting in order to investigate new therapeutics of lung cancer, offering new hope to patients for better survival and for improvements in quality of life. Blinded independent central reviews (BICRs) are advocated in clinical trials to in-dependently verify endpoints and control bias that might result from errors in response or progression assessments. In the BICR settings with double reads, the medical images are reviewed by two independent readers blinded to the results of the other reader, the study treatment, the investigator assessment, and some pre-defined clinical information. The double-reading paradigm creates the possibility for discordance between the two readers; therefore, a third radiologist is involved to make the final decision of the evaluation outcome. The monitoring of reader performance is required by regulatory bodies to ensure data quality and reliability. At the trial level, a high adjudication rate could be an alert of poor quality at the study level, and a low number of endorsements from a given reader would raise concerns about the reliability of that specific reader. Therefore, relevant key performance indicators (KPIs) must be designed and implemented before starting the reads; these allow the study monitor to trigger corrective actions accordingly. A pooled analysis of 79 oncology clinical trials showed that the proportion of cases requiring adjudication among the 11 lung cancer trials included in the analysis was 38% (95% CI: 37-40%). However, this study was general to all cancer types and did not included details on discrepancy root cause or recently approved novel therapeutics. Considering the atypical response patterns provided by those drugs, we thought it prudent to provide an update on reader performance specific to new therapeutics in lung cancer. Focusing on BICRs in assessing novel drugs, the aim of this study was to analyze a pool of lung trials using RECIST 1.1, document the proportion of reader discrepancies, and provide suggestions to aid in improving the read consistency of future trials by estimating relevant KPIs. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05038826
Study type Observational
Source Median Technologies
Contact
Status Active, not recruiting
Phase
Start date February 1, 2021
Completion date December 2021

See also
  Status Clinical Trial Phase
Completed NCT03918538 - A Series of Study in Testing Efficacy of Pulmonary Rehabilitation Interventions in Lung Cancer Survivors N/A
Recruiting NCT04548830 - Safety of Lung Cryobiopsy in People With Cancer Phase 2
Completed NCT04633850 - Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
Completed NCT00245154 - Paclitaxel + Carboplatin With/Out Cediranib Maleate in Stage III or Stage IV Non-Small Cell Lung Cancer Phase 2/Phase 3
Active, not recruiting NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Recruiting NCT03575793 - A Phase I/II Study of Nivolumab, Ipilimumab and Plinabulin in Patients With Recurrent Small Cell Lung Cancer Phase 1/Phase 2
Terminated NCT01624090 - Mithramycin for Lung, Esophagus, and Other Chest Cancers Phase 2
Terminated NCT03275688 - NanoSpectrometer Biomarker Discovery and Confirmation Study
Completed NCT01000025 - PF-00299804 in Stage IIIB or Stage IV Non-Small Cell Lung Cancer Not Responding to Standard Therapy for Advanced or Metastatic Cancer Phase 3
Not yet recruiting NCT04563234 - Perioperative Cognitive Training in Thoracic Surgery N/A
Not yet recruiting NCT04836975 - Reveal the Patterns of Presentation, Management and Outcome of Patients With SCLC and Stage III NSCLC in Saudi Arabia:
Not yet recruiting NCT04934865 - Real Life Study Evaluating the Clinical and Organisational Impact of Moovcare® Lung Connected Medical Device in Lung Cancer Patients : REAL-MOOV-LUNG N/A
Active, not recruiting NCT02538666 - An Investigational Immuno-therapy Study of Nivolumab, or Nivolumab in Combination With Ipilimumab, or Placebo in Patients With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based Chemotherapy Phase 3
Recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Active, not recruiting NCT02196844 - Yoga Program for Lung Cancer Patients and Caregivers N/A
Recruiting NCT04500535 - A Study of Participants With Advanced Non-Small Cell Lung Cancer Treated With Nivolumab in France After at Least One Prior Chemotherapy-based Treatment by Lung Initiative on Sequence Therapy
Recruiting NCT04957433 - 'Lung Health Check' Biomarker Study
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT03317080 - Dynamic Monitoring Circulating Tumor DNA in Surgical Patients With Lung Cancer