Evidence map›Paper›PMID 37115494›Full record

ArticlePharmaceutical medicine2023

Clinical and Regulatory Challenges and Opportunities for Monoclonal Antibodies in Low- and Middle-Income Countries: Lessons from COVID-19 and Beyond.

Lisa Gieber, Vincent Muturi-Kioi, Shelly Malhotra, Ayesha Sitlani

Abstract read
In one paragraph

Article in Pharmaceutical medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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

9 citing papers in PubMed.

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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.

Lisa GieberIAVI, 125 Broad St, 9th Floor, New York, NY, 10004, USA.
Vincent Muturi-KioiIAVI, The Address, 11th Floor Muthangari Drive, P.O. Box 340 KNH, Nairobi, Kenya, 00202.
Shelly MalhotraIAVI, 125 Broad St, 9th Floor, New York, NY, 10004, USA.
Ayesha SitlaniIAVI, 125 Broad St, 9th Floor, New York, NY, 10004, USA. asitlani@iavi.org.ORCID 0000-0003-3422-1752

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Monoclonal antibodies are an effective and growing class of pharmaceuticals for the treatment and prevention of a broad range of non-communicable and infectious diseases; however, most low- and middle-income countries have limited access to these innovative products. Many factors contribute to the global inequity of access to these products; however, in this report, we focus on clinical and regulatory complexities as further highlighted by the coronavirus disease 2019 pandemic. Despite a higher prevalence of many diseases in low- and middle-income countries, only 12% of clinical trials for monoclonal antibodies are conducted in these countries. Additionally, only a fraction of the available monoclonal antibodies in the USA and European Union are authorized for use in low- and middle-income countries. Through learnings from desk research and global symposia with international partners, we present recommendations to harmonize processes and facilitate regional and international collaborations for more rapid approval of fit-for-purpose innovative monoclonal antibodies and biosimilars in low- and middle-income countries.

Indexed as

Biosimilar PharmaceuticalsCOVID-19Antibodies, MonoclonalDeveloping CountriesEuropean UnionHumansAntibodies, MonoclonalBiosimilar Pharmaceuticals

Identifiers

PMID37115494
PMCPMC10141866

What OpenQuestion holds

Textmetadata
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.