Evidence map›Paper›PMID 35319446›Full record

ArticleHealthcare policy = Politiques de sante2022

The Importance of and Challenges with Adopting Life-Cycle Regulation and Reimbursement in Canada.

Melanie McPhail, Christopher McCabe, Dean A Regier, Tania Bubela

Abstract read
In one paragraph

Article in Healthcare policy = Politiques de sante, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Melanie McPhailResearch Associate, Faculty of Health Sciences, Simon Fraser University, Vancouver, BC.
Christopher McCabeCEO, Institute of Health Economics; Professor, Health Economics, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB.
Dean A RegierSenior Scientist, Canadian Centre for Applied Research in Cancer Control (ARCC), Cancer Control Research, BC; Cancer Associate Professor, School of Population and Public Health, University of British Columbia, Vancouver, BC.
Tania BubelaProfessor and Dean, Faculty of Health Sciences, Simon Fraser University, Vancouver, BC.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Regulatory and reimbursement decisions for drugs and vaccines are increasingly based on limited safety and efficacy evidence. In this environment, life-cycle approaches to evaluation are needed. A life-cycle approach grants market approval and/or positive reimbursement decisions based on an undertaking to conduct post-market clinical trials that address evidentiary uncertainties, relying on the collection and analysis of post-market data. In practice, however, both conditional regulatory and reimbursement decisions have proven problematic. Here we discuss some of the regulatory implications and unsettled ethical and pragmatic issues, taking lessons from the recent experiences of Israel in rapidly approving the Pfizer-BioNTech COVID-19 vaccine.

Indexed as

Drug ApprovalInsurance, HealthBNT162 VaccineCanadaCOVID-19HumansBNT162 Vaccine

Identifiers

PMID35319446
PMCPMC8935925

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.