Clinical trial applications for investigational medicinal products that contain or consist of genetically modified organisms: industry experiences under the European Union Clinical Trial Regulation (536/2014)
Bibliographic record
Abstract
The survey reported upon here provides an up to date understanding of industry experiences submitting national GMO applications since the CTR has been in application (January 31, 2022). The survey shows how time- and resource-intensive applications seeking authorizations for use of investigational medicinal products that contain or consist of genetically modified organisms (GMO-IMPs) to EU Member States continue to represent a significant challenge for developers. EU Member State GMO competent authorities presently apply differing interpretations of the European Commission Directives for Deliberate Release of GMOs and/or the Contained Use of GMOs. Survey feedback highlights how varied the different EU Member State GMO competent authority procedures and assessment timeframes are, with differences in adaptation to the timelines dictated by the Clinical Trial Regulation (CTR). Lengthy and uncertain timelines associated with EU Member State GMO competent authority procedures were indicated to have led sponsors to have looked to other regions (USA, Canada, and Australia) to host clinical trials with GMO-IMPs. The benefits of a single clinical trial application submission under the CTR are considerably diminished due to different national GMO procedural and documentation requirements and a lack of formal alignment of timelines between CTA and GMO procedures. EFPIA welcome the proposed improvements for regulation of GMO medicines through revision of the EU General Pharmaceutical Legislation.
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 distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.002 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
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 teacher head, 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".