Evidence map›Paper›PMID 34655224›Full record

ReviewClinical pharmacology and therapeutics2022

Use of RWE to Inform Regulatory, Public Health Policy, and Intervention Priorities for the Developing World.

Douglas McNair, Murray Lumpkin, Steven Kern, Daniel Hartman

Abstract readReview
In one paragraph

Review in Clinical pharmacology and therapeutics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing 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

15 citing papers in PubMed.

  1. Article
  2. Review
  3. Observational
  4. Article
  5. Review
  6. APPRAISE: A Tool for Appraising Potential for Bias in Real-World Evidence Studies on Medication Effectiveness or Safety.Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research · 2025
    Article
  7. Observational
  8. Review
  9. Article
  10. Review
  11. Real-world evidence: experiences and challenges for decision making in Latin America.International journal of technology assessment in health care · 2023
    Article
  12. Data Challenges for Externally Controlled Trials: Viewpoint.Journal of medical Internet research · 2023
    Article
  13. Article
  14. Review
  15. 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.

Douglas McNairGlobal Health, Integrated Development, Bill & Melinda Gates Foundation, Seattle, Washington, USA.
Murray LumpkinGlobal Health, Integrated Development, Bill & Melinda Gates Foundation, Seattle, Washington, USA.
Steven KernGlobal Health, Integrated Development, Bill & Melinda Gates Foundation, Seattle, Washington, USA.
Daniel HartmanGlobal Health, Integrated Development, Bill & Melinda Gates Foundation, Seattle, Washington, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

For low- and middle-income countries (LMICs) to benefit from real-world evidence (RWE)/real-world data (RWD) in both product registration ("regulatory") decision making and in product utilization policy ("policy") decision making, they need to overcome several challenges. They need to deploy more electronic health records systems (EHRs), adjust for confounder variables, build trust between stakeholders, and create laws and regulations for local generation of data that are assented for secondary use. The role of procurers and their use of RWE/RWD in the LMIC context likewise is in a state of ongoing development. Procurers of health products are strong players currently in the "access" chain as LMICs continue to work on strengthening governmental health technology assessment (HTA) bodies. Procurers' use of RWE is presently at an early stage and is mostly indirect, leveraging RWE results that are produced by researchers in high-income countries (HICs), often under considerably different regulatory and policy objectives and constraints compared to LMICs' epidemiology and priorities. Pending wider deployment of EHRs and other RWE sources, stakeholders must realize that populations from HIC RWE (i) can be devised to closely resemble phenotypic patterns in LMIC populations and (ii) can be analyzed to align with LMICs' unmet needs.

Indexed as

Developing CountriesDrug and Narcotic ControlHealth PolicyDecision MakingEvidence-Based MedicineHumans

Identifiers

PMID34655224
PMCPMC9298255

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.