Abstract 3622: End of Trial Period for Randomized Controlled Cardiology Trials: Is patient safety monitored and protected?
Bibliographic record
Abstract
Background: The post trial period is the period after the end of study drug administration. The Declaration of Helsinki (DOH) states that “at the conclusion of the study, every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic and therapeutic methods identified by the study.” It further adds that “post trial access arrangements or other care must be described in the study protocol so the ethical review committee may consider such arrangements during its review.” Therefore our objectives were: to determine whether research trial protocols systematically consider post trial period issues including planned follow-up and patient surveillance in the post trial period; and to assess if consent forms addressed end of trial issues. Methods: We searched the research ethics board (REB) databases at 2 academic institutions in Toronto from 1995 to 2006 to identify approved randomized clinical trials of chronic medical therapies for cardiac conditions. Results: Fourty-two studies were identified including 18 heart failure and 15 coronary artery disease trials. Thirty-eight of these trials were industry funded. Almost all trials (n=37) ended study drug abruptly at the last clinic visit, while only 4 studies offered a clinical visit post trial termination, and an additional 3 reported a telephone contact after trial completion. Only 5 trials submitted consent forms to the REB with a discussion of the post trial period. After REB review, no additional consent forms addressed the post trial period. When comparing the time period before and after the updated version of the DOH in 2000, there was a trend towards a decline in addressing post trial care (p=0.08). Conclusion: The majority of cardiac trials end study drug abruptly with unknown and potentially negative consequences, and most patients have no systematic post trial follow up from trial investigators. Study patients are also not made aware of the post trial period, as the majority of study consent forms do not discuss post trial care. Therefore, an important aspect of clinical trial design, the post trial period, could be improved by systematic follow-up described in the protocol, and full discussion of this aspect of trial participation in the consent form.
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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 | 0.569 | 0.750 |
| Meta-epidemiology (narrow) | 0.001 | 0.002 |
| Meta-epidemiology (broad) | 0.004 | 0.003 |
| Bibliometrics | 0.008 | 0.018 |
| Science and technology studies | 0.003 | 0.010 |
| Scholarly communication | 0.015 | 0.011 |
| Open science | 0.004 | 0.004 |
| Research integrity | 0.009 | 0.007 |
| Insufficient payload (model declined to judge) | 0.012 | 0.005 |
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".