ReviewInternational journal of technology assessment in health care2024
Early technology review: towards an expedited pathway.
Review in International journal of technology assessment in health care, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
7 citing papers in PubMed.
- Smart responsive hydrogels combined with AI design for tumor therapy.Acta pharmaceutica Sinica. B · 2026Review
- Early technology review during prototype development and at proof of concept: the case for developing a sequential versus a single-stage approach to early evidence development for health technologies.International journal of technology assessment in health care · 2026Review
- From Architecture to Outcomes: Mapping the Landscape of Digital Twins for Personalized Diabetes Care-A Scoping Review.Journal of personalized medicine · 2025Review
- Defining early health technology assessment: building consensus using Delphi technique.International journal of technology assessment in health care · 2025Article
- Competency gaps and institutional challenges for translational research in medical devices: insights from Brazilian researchers.BMC medical education · 2025Article
- Regulatory landscape of accelerated approval pathways for medical devices in the United States and the European Union.Frontiers in medical technology · 2025Review
- Assessing health technology implementation during academic research and early-stage development: support tools for awareness and guidance: a review.Frontiers in digital health · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesEvidence development for medical devices is often focused on satisfying regulatory requirements with the result that health professional and payer expectations may not be met, despite considerable investment in clinical trials. Early engagement with payers and health professionals could allow companies to understand these expectations and reflect them in clinical study design, increasing chances of positive coverage determination and adoption into clinical practice.
methodsAn example of early engagement through the EXCITE International model using an early technology review (ETR) is described which includes engagement with payers and health professionals to better inform companies to develop data that meet their expectations. ETR is based on an early evidence review, a framework of expectations that guides the process and identified gaps in evidence. The first fourteen ETRs were reviewed for examples of advice to companies that provided additional information from payers and health professionals that was thought likely to impact on downstream outcomes or strategic direction. Given that limitations were imposed by confidentiality, examples were genericized.
resultsAdvice through early engagement can inform evidence development that coincides with expectations of payers and health professionals through a structured, objective, evidence-based approach. This could reduce the risk of business-related adverse outcomes such as failure to secure a positive coverage determination and/or acceptance by expert health professionals.
conclusionsEarly engagement with key stakeholders exemplified by the ETR approach offers an alternative to the current approach of focusing on regulatory expectations. This could reduce the time to reimbursement and clinical adoption and benefit patient outcomes and/or health system efficiencies.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.