Abstract
Introduction: Publication bias in the form of discontinued or unpublished trials may warp our understanding of urologic oncology. This is due to trials dictating clinical practice are the ones that are completed and published. To evaluate publication bias in urologic oncology, our study measured the rates of discontinued and unpublished urologic oncology trials. These are preliminary findings as we wait for trialists to confirm their trial’s status and provide reasoning for their discontinued or unpublished trial.
Methods: We used ClinicalTrials.gov (CT.gov) to search for trials using the following search terms: Urothelial Neoplasm, Urologic Neoplasms, Kidney Neoplasms, Bladder Neoplasms, Prostate Neoplasm, Testicular Neoplasms, and Penile Neoplasms. Trial NCT numbers and CT.gov were used to collect the following from each trial: recruitment status, participants, and funding. Trials exclusion criteria were based on final recruitment status and trial phase. Trials at least phase 3 or higher were included. Trials reported as terminated, withdrawn, unknown, or suspended were considered discontinued. We reviewed CT.gov for each included trial for trial publications. If unsuccessful, we then searched PubMed and others using trial information to confirm publication status. These findings were compiled for descriptive statistics.
Results: Our search yielded 665 trials. After exclusion, 458 were included. Of the 458 trials, 334 (72.93%) were completed and 124 (27.07%) were discontinued. Of the 124 discontinued trials, 14 (11.29%) received federal funding, 49 (39.52%) received partial industry funding, 60 (48.39%) received funding from other sources, and 1 (0.81%) received industry and federal funding. Of all participating patients, 12.42% (28,206/227,088) participated in discontinued trials. Regarding publication status, we found that of 458 trials, 181 (39.52%) were unpublished. Of the 181 unpublished studies, 102 (56.35%) were from completed trials. For the 181 unpublished trials, 20 (11.05%) trials received federal funding, 3 (1.66%) received federal and industry funding, 84 (46.41%) received industry funding, and 72 (28.57%) received funding from other sources. Of all patient participants, 33,420 (14.72%) were involved with unpublished studies.
Conclusion: A substantial portion of trials were discontinued and unpublished. This affects our understanding of urologic oncology, those funding the trials, and the patients enrolled. We hope to use trialist responses in our final study to determine how we can improve this issue.
Funding: N/A
Methods: We used ClinicalTrials.gov (CT.gov) to search for trials using the following search terms: Urothelial Neoplasm, Urologic Neoplasms, Kidney Neoplasms, Bladder Neoplasms, Prostate Neoplasm, Testicular Neoplasms, and Penile Neoplasms. Trial NCT numbers and CT.gov were used to collect the following from each trial: recruitment status, participants, and funding. Trials exclusion criteria were based on final recruitment status and trial phase. Trials at least phase 3 or higher were included. Trials reported as terminated, withdrawn, unknown, or suspended were considered discontinued. We reviewed CT.gov for each included trial for trial publications. If unsuccessful, we then searched PubMed and others using trial information to confirm publication status. These findings were compiled for descriptive statistics.
Results: Our search yielded 665 trials. After exclusion, 458 were included. Of the 458 trials, 334 (72.93%) were completed and 124 (27.07%) were discontinued. Of the 124 discontinued trials, 14 (11.29%) received federal funding, 49 (39.52%) received partial industry funding, 60 (48.39%) received funding from other sources, and 1 (0.81%) received industry and federal funding. Of all participating patients, 12.42% (28,206/227,088) participated in discontinued trials. Regarding publication status, we found that of 458 trials, 181 (39.52%) were unpublished. Of the 181 unpublished studies, 102 (56.35%) were from completed trials. For the 181 unpublished trials, 20 (11.05%) trials received federal funding, 3 (1.66%) received federal and industry funding, 84 (46.41%) received industry funding, and 72 (28.57%) received funding from other sources. Of all patient participants, 33,420 (14.72%) were involved with unpublished studies.
Conclusion: A substantial portion of trials were discontinued and unpublished. This affects our understanding of urologic oncology, those funding the trials, and the patients enrolled. We hope to use trialist responses in our final study to determine how we can improve this issue.
Funding: N/A
| Original language | American English |
|---|---|
| Pages | 232 |
| State | Published - 2 Oct 2021 |
| Event | Annual Meeting of the South Central Section of the AUA - Scottsdale, Arizona Duration: 29 Sep 2021 → 2 Oct 2021 |
Conference
| Conference | Annual Meeting of the South Central Section of the AUA |
|---|---|
| City | Scottsdale, Arizona |
| Period | 29/09/21 → 2/10/21 |