A compendium of unpublished phase III clinical trials in oncology: Characteristics and impact on clinical practice.
Bibliographic record
Abstract
6029 Background: Phase III clinical trials provide the highest level of evidence to inform treatment decisions. A large number of phase III clinical trials are presented at ASCO annual meetings each year but 26% remain unpublished within 5 years of presentation. The results of these unpublished trials, if more generally known, may have a substantial impact on clinical practice. Methods: We identified abstracts of phase III clinical trials with sample size ≥ 200 that evaluated systemic treatment for cancer by hand searching the conference proceedings of ASCO annual meetings between 1989 and 2003. PubMed, Medline and Embase were searched for corresponding publications. A compendium of unpublished phase III clinical trials was assembled. The clinical significance of nonpublication was determined by experts in each oncology site group at Princess Margaret Hospital and Sunnybrook Odette Cancer Centre, Toronto, Canada. Results: A total of 713 phase III trials were identified and our initial search suggested that 80 remained without a subsequent publication by 2009. After contacting the authors of the abstracts an additional 8 studies were found to be published and 3 were in press, leaving 69 abstracts without a subsequent publication. Unpublished trials included those for patients with breast cancer (n = 24), gastrointestinal cancer (n = 14), lung cancer (n = 9), hematologic malignancies (n = 9), gynecologic cancer (n = 6), genitourinary cancer (n = 4), central nervous system tumors (n = 2) and head and neck cancer (n = 1). 51% of these abstracts were presented orally and 29% as posters. 68% of the unpublished abstracts reported non-significant results. In the opinion of the experts, a number of unpublished trials would have had at least some effect on clinical practice if their results had been published promptly, including 10 of the 14 gastrointestinal cancer trials and 3 of the 9 lung cancer trials. Conclusions: A considerable proportion of large phase III trials remain unpublished at least 6 years following presentation at ASCO annual meetings. Nonpublication breaks the contract made by investigators with patients, funding agencies and ethics boards, and can adversely influence clinical practice. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration AstraZeneca, Exelixis, Roche
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.095 | 0.311 |
| Meta-epidemiology (narrow) | 0.003 | 0.003 |
| Meta-epidemiology (broad) | 0.007 | 0.005 |
| Bibliometrics | 0.042 | 0.035 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.008 | 0.005 |
| Open science | 0.004 | 0.004 |
| Research integrity | 0.004 | 0.004 |
| Insufficient payload (model declined to judge) | 0.038 | 0.018 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".