Written by Sneha Bhadti, David Pritchett, & Susan O’Connell
The implementation of the European Union (EU) joint medical evaluation (JCA) course of is quick approaching. In January 2025, the JCA will likely be rolled out for brand spanking new oncology and orphan drugs. Supply has already printed a weblog introducing the EU JCA framework.
Crucially, JCA submissions will contain consolidated inhabitants, intervention, comparator, consequence, and research design (PICOS) standards for all EU member states. These will likely be finalised 90 days previous to the submission. Since PICOS standards are pivotal in structuring the analysis query and methodology for systematic literature opinions (SLRs), the introduction of the JCA course of could have a serious impression on how medical SLRs are carried out.
Extra PICOS standards and shorter timelines
Range within the administration of particular illnesses throughout EU member states will end in a number of discrete PICOS standards for a single JCA submission. The EUNet21 have already printed two JCAs for medical units: one for the Optilume® urethral drug-coated balloon, and one other for the Evoke® Spinal Twine Stimulation System. The consolidated PICOS standards for each assessments had been composed of three discrete PICOS standards, whereas analysis from the European Federation of Pharmaceutical Industries and Associations (EFPIA) suggests there’s the potential for a lot of extra PICOS standards for different applied sciences and indications. Utilizing anonymised interventions, an orphan medicine for a strong metastatic tumour indication required 16 discrete PICOS standards involving 2 populations and 15 comparators, whereas a haematological most cancers indication within the first‑line setting required 57 separate PICOS standards involving 6 populations and 23 comparators. Therefore, relying on the illness in query, the variety of discrete PICOS standards could possibly be very excessive, introducing appreciable complexity to the medical SLR. Mixed with the 90-day timeframe between finalisation of the PICOS standards and the submission deadline, the very best method to performing an SLR for a JCA submission requires cautious consideration.
The significance of planning
A number of approaches could possibly be thought of when approaching the SLR for a JCA submission, every of which has benefits and drawbacks (Desk 1).
One method can be to carry out the SLR upfront of PICOS consolidation, after conducting rigorous desk analysis to foretell the ultimate PICOS standards. The goal of this analysis can be to determine how the illness in query is at the moment managed throughout every of the 27 EU member states.
An alternate method can be to carry out the SLR upfront of PICOS consolidation, adopting broad PICOS standards to minimise threat and canopy all attainable bases within the consolidated PICOS. These broad standards are prone to embody objects that in the end don’t function within the remaining PICOS, so in the course of the 90-day interval previous to submission, the included publications would should be filtered right down to these aligned with the consolidated PICOS. This methodology might keep away from a last-minute scramble to replace the SLR with further PICOS objects within the remaining three months earlier than submission. Furthermore, there’s the potential for sufficiently broad SLRs to be re-used throughout a number of submissions in the identical illness space.
A 3rd possibility can be to carry out the SLR from begin to end in the course of the 90-day pre-submission interval. This method would make sure the SLR is totally aligned with the consolidated PICOS standards, however is barely prone to be possible for very small SLRs, for instance these for uncommon illnesses or indications for which only a few remedies can be found. Even on this situation, in depth planning and dialogue of the SLR protocol can be required upfront of PICOS consolidation, such that screening might start as quickly because the PICOS is finalised.
Every of the strategies described right here has its personal benefits and drawbacks. In observe, probably the most applicable method to the SLR could range primarily based on the indication, funds, and time and assets accessible, and may due to this fact be decided on a project-by-project foundation. Given the extraordinarily tight timelines, synthetic intelligence (AI)/machine studying (ML) instruments could show notably helpful in the course of the scoping, screening and/or knowledge extraction levels of SLRs for JCA submissions; nonetheless, additional optimisation and validation of those instruments remains to be required, as is evident steering that AI/ML instruments can be accepted by JCA assessors. No matter which method is chosen, early planning and dialogue of the SLR will likely be completely important given the very restricted time accessible between PICOS consolidation and submission.
If you need to study extra about systematic literature opinions, please contact Supply Well being Economics, an impartial consultancy specialising in proof era, well being economics, and communication.
