Arthritis Clinical Trials at a Crossroad
Bibliographic record
Abstract
With more than a century of combined trial experience, we discuss the demise of pharmaceutical company inflammatory arthritis clinical trials, speaking from our experience in Canada while potentially generalizing to the United States, Western Europe, and other regions where patients have reasonable access to medical care and therapeutics. The purpose of this editorial is 2-fold: to raise awareness of the critical state of rheumatology clinical trials in Canada; and to describe the increasingly insurmountable barriers facing trialists because of difficulty recruiting owing to trial designs (some requiring substandard care for participation); recent changes in trial operations and management; and the financial burden placed on trialists. The challenges are not unique to rheumatology1,2. Many industry-funded trials are not feasible. This can shift investigators to conducting non-pharmaceutical trials to answer challenging important questions, but the trials are usually extremely underfunded, creating a barrier to participation. Traditionally, clinical research has been the only means whereby advances in medicine can be translated into excellent patient care. Trial participation facilitates greater acceptance of innovative treatments and the integration of successful treatments into optimal care. There is no replacement for phase II and III clinical trial experience: Clinical trialists are early adopters and comfortable prescribers of new therapies once they are approved because they have acquired invaluable experience of novel products. In contrast, current trials are mostly bureaucratic and time-consuming to initiate and conduct, and they do not reflect the population studied. In fact, clinical research is becoming increasingly onerous with respect to regulatory and administrative requirements and is very expensive (in people and time resources) while, simultaneously, recruitment has dwindled (years ago, sites could enroll 10 subjects in a study vs 0 to 4 per study today). Thus, incurred costs are not recovered. Moreover, recruitment is limited by trial designs that … Address correspondence to Dr. J.E. Pope, 268 Grosvenor St., London, Ontario N6A 4V2, Canada. E-mail: janet.pope{at}sjhc.london.on.ca
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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 | 0.075 | 0.154 |
| Meta-epidemiology (narrow) | 0.002 | 0.002 |
| Meta-epidemiology (broad) | 0.004 | 0.003 |
| Bibliometrics | 0.004 | 0.005 |
| Science and technology studies | 0.004 | 0.013 |
| Scholarly communication | 0.028 | 0.026 |
| Open science | 0.004 | 0.008 |
| Research integrity | 0.023 | 0.048 |
| Insufficient payload (model declined to judge) | 0.025 | 0.020 |
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".