Evidence map›Paper›PMID 34906688›Full record

ArticleDrug discovery today2022

Regulatory oversight on the use of experimental therapies during a pandemic: The case of early access to convalescent plasma therapy in three LMICs.

Rosemarie Bernabe, Cristina Torres, Grace Wangge, Edlyn Jimenez, Juntra Karbwang

Abstract read
In one paragraph

Article in Drug discovery today, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

5 authors.

Rosemarie BernabeFaculty of Health and Social Sciences, University of South-Eastern Norway, Norway; Centre for Medical Ethics, Institute of Health and Society, University of Oslo, Norway. Electronic address: Rosemarie.Bernabe@usn.no.
Cristina TorresNational Institutes of Health, UP Manila, Philippines; SIDCER-FERCAP Foundation, Pathumthani, Thailand.
Grace WanggeSoutheast Asian Ministry of Education - Regional Center for Food and Nutrition (SEAMEO- RECFON), Indonesia.
Edlyn JimenezNational Institutes of Health, UP Manila, Philippines.
Juntra KarbwangSIDCER-FERCAP Foundation, Pathumthani, Thailand.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Clinicians, especially in low- and middle-income countries (LMICs), contend with limited economic and healthcare resources in deciding appropriate and feasible care for their patients. Some of the LMICs affected by COVID-19 implemented convalescent plasma therapy without sufficient regulatory guidance. Based on this experience, there are several requirements going forward, including: the need for an immediately accessible data gathering and processing system; the necessity of establishing regulatory pathways for early access to experimental treatment during emergency situations; and the accompanying reporting and monitoring requirements must be set. The different stakeholders must also be properly incorporated in the system that such a pathway will create, without neglecting to properly inform the public of the patient rights especially during an emergency situation.

Indexed as

COVID-19COVID-19 SerotherapyDeveloping CountriesHumansImmunization, PassivePandemicsPovertyTherapies, InvestigationalCOVID-19Early accessExperimental therapiesLMICsRegulatory oversight

Identifiers

PMID34906688
PMCPMC8664719

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.