Multistakeholder scientific advice for medicinal products used in combination with a medical device or a companion diagnostic in the EU—summary of a Focus group discussion
Bibliographic record
Abstract
diagnostics (IVDs) and software as a medical device, their development in the EU is proving to be more challenging due to the complexities in working across the regulatory frameworks for medicinal products, medical devices and IVDs. One of the concerns is the lack of a multistakeholder platform [European Medicines Agency (EMA)/Scientific Advice Working Party (SAWP); National Competent Authorities (NCAs) in charge of medicinal products; NCAs for medical devices; notified bodies (NBs)] for scientific and regulatory advice on medicinal products used in combination with medical devices or IVDs [including companion diagnostics (CDx)]. A multistakeholder platform would allow for an opportunity to discuss the scientific expectations of the different decision makers involved and guide the identification of an appropriate development path for both medicine and medical device/IVD (including CDx). In search of a pragmatic approach to facilitate discussions on evidence generation plans, it was agreed in the "9th EMA-Industry stakeholder platform on research and development support" meeting in December 2022 to set up a dedicated Focus group to determine the possibility of provision of scientific advice for medicinal products in combination with a medical device or IVD (including CDx). The Focus group had participants from the EMA SAWP, the NCAs, the NBs, and industry and the EMA. The group explored what kind of scientific questions would benefit from being addressed in comprehensive discussions on evidence generation planning in a multistakeholder setting, and who would be the required decision makers and experts for such multidisciplinary discussions. The discussions covered nine study cases: four were drug-device combinations and five were drug-IVD/CDx combinations. The scope of the discussions excluded stand-alone high-risk medical devices and IVDs for which there was an ongoing scientific advice pilot involving the medical device expert panels. In addition, low-risk stand-alone medical device/IVD developments were also out-of-scope. This article presents the insights of the discussions on the nine study cases reviewed by the Focus group and explores options for next steps to inform future policy and technical discussions on these innovative healthcare developments.
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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 | 0.098 | 0.077 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.002 | 0.001 |
| Science and technology studies | 0.011 | 0.003 |
| Scholarly communication | 0.006 | 0.008 |
| Open science | 0.003 | 0.012 |
| Research integrity | 0.013 | 0.011 |
| Insufficient payload (model declined to judge) | 0.010 | 0.001 |
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".