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Seamless trials in oncology: A cross-sectional analysis of characteristics and reporting
Katarzyna Klas1,2, Karolina Strzebonska1, Paola Buedo1
1Faculty of Health Sciences, Research Ethics in Medicine Study Group (REMEDY), Jagiellonian University Medical College, Krakow, Poland.
Objectives:
Seamless clinical trials have received much attention as a possible way to expedite drug development. The growing importance of seamless design can be seen in oncology research, especially in the early stages of drug development. Our objective is to examine the basic characteristics of seamless early-phase oncology trials registered on the ClinicalTrials.gov database and to determine their results reporting rates. We also aim to identify factors associated with results reporting.
Methods:
Cross-sectional study. We defined seamless early-phase trials as either those registered as Phase 1/2 or Phase 1 with planned expansion cohort(s). Using the ClinicalTrials.gov registry, we searched for interventional cancer clinical trials with primary completion date (PCD) between 2016 and 2020. After trial selection, we performed manual data extraction based on the trial record description and the results posted in the trial registry. We used logistic regression to search for predictors of results reporting. Protocol: https://osf.io/m346x/.
Results:
We included 1051 seamless early-phase oncology trials reported as completed (PCD) between 2016 and 2020. We provided descriptive statistics including the number of patients enrolled, study start date, primary completion date, funding, type of intervention, cancer type, design details, type of endpoints, recruitment regions, and number of trial sites. Overall, only 34.7% trials reported results on ClinicalTrials.gov. The results reporting rates for 24 months was 24.0%. The overall reporting rate for Phase 1/2 studies was over three times higher than for seamless Phase 1.
Conclusions:
Our study provides cross-sectional data on seamless early-phase oncology trials registered on ClinicalTrials.gov. We highlight the challenges of the evolving clinical trial design landscape and the problem of missing results in the seamless design context, which raises serious ethical concerns. Efforts should be made to adapt the functionality of the ClinicalTrials.gov database to emerging clinical trial models.
Insights
Seamless early-phase oncology trials show low results reporting rates, with only 34.7% of studies disclosing findings. Phase 1/2 seamless trials reported results more often than seamless Phase 1 trials.
Area of Science:
- Oncology
- Clinical Trials
- Drug Development
Background:
- Seamless clinical trial designs are increasingly utilized to expedite drug development, particularly in early-phase oncology research.
- These designs integrate multiple study phases into a single trial, aiming for greater efficiency.
- However, the reporting rates and associated factors for seamless early-phase oncology trials remain underexplored.
Purpose of the Study:
- To analyze the characteristics of seamless early-phase oncology trials registered on ClinicalTrials.gov.
- To determine the results reporting rates for these trials.
- To identify factors influencing results reporting in seamless oncology trials.
Main Methods:
- A cross-sectional study was conducted using data from ClinicalTrials.gov.
- Seamless early-phase trials were defined as Phase 1/2 or Phase 1 with planned expansion cohorts.
- Data from 1051 completed trials (2016-2020) were manually extracted, and logistic regression was used to identify predictors of results reporting.
Main Results:
- Out of 1051 seamless early-phase oncology trials, only 34.7% reported results on ClinicalTrials.gov.
- The results reporting rate within 24 months of primary completion date was 24.0%.
- Phase 1/2 seamless trials demonstrated a reporting rate over three times higher than seamless Phase 1 trials.
Conclusions:
- A significant proportion of seamless early-phase oncology trials have incomplete results reporting on ClinicalTrials.gov.
- The low reporting rate poses ethical concerns and challenges the transparency of evolving clinical trial designs.
- Adaptations to ClinicalTrials.gov are recommended to better accommodate emerging trial models and improve data accessibility.
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