ArticleInternational journal of technology assessment in health care2023
Regulatory, health technology assessment and company interactions: the current landscape and future ecosystem for drug development, review and reimbursement.
Article in International journal of technology assessment in health care, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 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
9 citing papers in PubMed, 9 citations in OpenAlex.
- From Compliance to Strategic Partner: The Transformation of Regulatory Affairs in AstraZeneca Local Affiliates.Pharmaceutical medicine · 2026Article
- Introduction of early health technology assessment for innovators, clinicians, and funders.npj health systems · 2026Review
- Impact of Market Access Delays on Time to Patient Access: Multi-Country Comparative Analysis Assessing the First Commercial Launch Indications for Five Oncology Medicines Across Europe and Canada.Journal of market access & health policy · 2026Article
- HTA submission strategies and their associations with rollout times and type of HTA recommendation in Australia and Canada.International journal of technology assessment in health care · 2026Observational
- Managing costly new drugs to support equitable access: international collaboration and patient engagement to assess value, and managed entry agreements.BMJ (Clinical research ed.) · 2025Article
- Identification and Description of Regulatory and Health Technology Assessment Agencies' Guidance Related to Patient Experience Data in North America, Europe, and Asia Pacific.Therapeutic innovation & regulatory science · 2025Article
- Patient Engagement and Patient Experience Data in Regulatory Review and Health Technology Assessment: Where Are We Today?Therapeutic innovation & regulatory science · 2025Review
- Importance of Health Economics and Outcomes Research in the Product Lifecycle.Pharmaceutical medicine · 2025Review
- The Critical Intersect of Regulations, Health Technology Assessment, and Drug Safety Assessments.Drug safety · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 2 countries.
Funding
Abstract
backgroundMulti-stakeholder interactions have evolved at product and policy levels. There is a need to assess the current and future landscape of interactions between companies, and regulatory and HTA agencies to address challenges and identify areas for improvement.
objectivesThe aims of this study were to review the current interactions within and across regulatory and HTA agencies, and companies' experiences in engaging in these activities; to assess the added value of interactions as well as limitations; to explore the future ecosystem for stakeholder interactions.
methodThree separate questionnaires were developed for companies, regulators and HTA agencies, respectively, to assess their experiences and perceptions. The responses were analyzed using descriptive statistics and discussed at a multi-stakeholder workshop. Key outcomes from the surveys and workshop discussion were reported.
resultsAll seven regulators and seven HTA agencies in the survey indicated that they had stakeholder interactions. More formal collaboration occurred with regulators compared with HTA agencies. All nine companies have taken early advice but indicated the need for future prioritization. Success indicators can be built at the product and therapy levels, with the added value of faster patient access. Four principles were proposed for the future ecosystem: separate remit and functions between regulators and HTA; align processes; converge evidence requirements where possible; increase transparency.
conclusionsThis research brought together regulators, HTA agencies, companies to examine how they interact with one another. We propose measures of value and make recommendations on future evolution to enable better evidence generation and improve regulatory and HTA decision-making.
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.