The Results of Well-conducted Negative Clinical Trials Should Be Reported in a Peer-reviewed Journal
Bibliographic record
Abstract
We expect that the pathogenesis, manifestations, and successful management of disease will be fully reported in peer-reviewed journals. However, there are multiple publications addressing the likelihood that clinical trials that do not report a positive result are underreported in the medical literature, with a maximum of 50% of negative studies published, even after 5 years of availability of their results1,2. One way to think of the usefulness of our literature is as a road map. There are major “highways” (positive reports), “secondary roads” (major secondary considerations such as long-term safety and effectiveness), and “attractions” (opinions, historical correlations, etc.). But importantly, we need to be able to determine “detours and roadblocks” (well-performed negative studies), which are transparently reported. In this issue of The Journal of Rheumatology , Genovese and colleagues report the results of a clinical trial exploring the efficacy and safety of poseltinib, a Bruton tyrosine kinase inhibitor (BTKi), which was found to be ineffective in the treatment of rheumatoid arthritis (RA) in a phase II study3. This is an important addition to our literature. BTK is a tyrosine kinase that is encoded by the BTK gene in humans. In 1993 it was identified that BTK is the gene defective in primary immunodeficiency X-linked agammaglobulinemia. BTK is a member of the Tec family of nonreceptor tyrosine kinases and is expressed in all hematopoietic cells except T cells and terminally differentiated plasma cells. It has been shown that BTK has an important role in B cell differentiation in vivo and is involved in the regulation of the expansion and developmental progression of pre-B cells in the bone marrow. BTK is a crucial signal transducer of signals downstream of the IgM or IgG B cell antigen receptor in mature B cells governing proliferation, survival, and differentiation. … Address correspondence to Dr. R. Fleischmann, 8144 Walnut Hill Lane, Suite 810, Dallas, TX 75231, USA. Email: rfleischmann{at}arthdocs.com.
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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 | 0.244 | 0.558 |
| Meta-epidemiology (narrow) | 0.002 | 0.003 |
| Meta-epidemiology (broad) | 0.011 | 0.004 |
| Bibliometrics | 0.016 | 0.007 |
| Science and technology studies | 0.005 | 0.007 |
| Scholarly communication | 0.033 | 0.019 |
| Open science | 0.006 | 0.006 |
| Research integrity | 0.024 | 0.019 |
| Insufficient payload (model declined to judge) | 0.050 | 0.063 |
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; the direct Gemma label and the distilled Codex classifier agree on what is shown here.
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".