Lung CancerNCT05038826
BICR in New Therapeutic Lung Cancer Trials
An observational study of Lung Cancer, run by Median Technologies at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer
- How many people
- 1,833 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2021to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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".
Who may be able to join
- 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)
Who cannot join
- reader evaluation with less than 25 adjudications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blinded Independent Central Review (BICR) in New Therapeutic Lung Cancer Trials
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.
Read the detailed 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.
- Conditions
- Lung Cancer
- Keywords
- blinded independent central review, RECIST1.1
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
inter-reader discordance rate
- 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
- 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
- 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
Measured: 6 months
Secondary outcomes (4)
endorsement rate
Readers' endorsement rate from pooled trials as, for each readers, the proportion of adjudication in their favor
Measured: 6 months
adjudication rationale
Proportion of deemed "errors" and "medically justifiable differences" after adjudication
Measured: 6 months
Correlation between discrepancy rate and timepoints
Correlation between discrepancy rate and the average number of time points per patient
Measured: 6 months
root cause
Reasons for adjudications after root cause analysis
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start1 Feb 2021
- Primary completion10 Aug 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,833 participants (actual)
Sponsor and investigators
- Lead sponsor
- Median Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05038826
- Sponsor's protocol ID
- Median202101
- Status last verified
- Mar 2023
- First submitted
- 1 Sep 2021
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blinded Independent Central Review (BICR) in New Therapeutic Lung Cancer Trials
- ClinicalTrials.gov ID
- NCT05038826
- Acronym / sponsor ID
- Median202101
- Conditions
- Lung Cancer
- Keywords
- blinded independent central review, RECIST1.1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,833 participants (actual)
- Lead sponsor
- Median TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 10 Aug 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 9 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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".
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- reader evaluation with less than 25 adjudications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
inter-reader discordance rate
Time frame: 6 months
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
4 secondary outcomes
endorsement rate
Time frame: 6 months
adjudication rationale
Time frame: 6 months
Correlation between discrepancy rate and timepoints
Time frame: 6 months
root cause
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Median Technologies at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
inter-reader discordance rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.