Evidence map›Paper›PMID 32727913›Full record

ReviewScience translational medicine2020

Scientific considerations for global drug development.

Jennifer L Wilson, Kit Wun Kathy Cheung, Lawrence Lin, Elizabeth A E Green, Analia I Porrás, Ling Zou, David Mukanga, Paul A Akpa, Delese Mimi Darko, Rae Yuan and 13 more

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Science translational medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
  4. Review
  5. Article
  6. 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

23 authors.

Jennifer L WilsonDepartment of Bioengineering and Therapeutic Sciences, University of California, San Francisco, San Francisco, CA, USA.ORCID 0000-0002-2328-2018
Kit Wun Kathy CheungDepartment of Bioengineering and Therapeutic Sciences, University of California, San Francisco, San Francisco, CA, USA.ORCID 0000-0002-5541-3617
Lawrence LinDepartment of Bioengineering and Therapeutic Sciences, University of California, San Francisco, San Francisco, CA, USA.ORCID 0000-0003-4248-9740
Elizabeth A E GreenDepartment of Bioengineering and Therapeutic Sciences, University of California, San Francisco, San Francisco, CA, USA.
Analia I PorrásMedicines and Health Technologies Unit, Department of Health Systems and Services, Pan American Health Organization, Regional Office of the World Health Organization, Washington, DC, USA.ORCID 0000-0003-1831-4625
Ling ZouDepartment of Bioengineering and Therapeutic Sciences, University of California, San Francisco, San Francisco, CA, USA.ORCID 0000-0002-0128-7950
David MukangaGlobal Health, Bill and Melinda Gates Foundation, Seattle, WA, USA.ORCID 0000-0001-5554-7466
Paul A AkpaDepartment of Pharmaceutics, University of Nigeria, Nsukka, Enugu State, Nigeria.
Delese Mimi DarkoFood and Drugs Authority, Accra, Ghana.
Rae YuanSinovant Sciences Co., Shanghai, China.
Sheng DingSchool of Pharmaceutical Sciences, Tsinghua University, Beijing, China.
Wiltshire C N JohnsonPharmacy Board of Sierra Leone, Freetown, Sierra Leone.
Howard A LeeDepartment of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.
Emer CookeWorld Health Organization, Geneva, Switzerland.
Carl C PeckDepartment of Bioengineering and Therapeutic Sciences, University of California, San Francisco, San Francisco, CA, USA.ORCID 0000-0003-0196-9668
Steven E KernGlobal Health, Bill and Melinda Gates Foundation, Seattle, WA, USA.ORCID 0000-0002-2849-0836
Dan HartmanGlobal Health, Bill and Melinda Gates Foundation, Seattle, WA, USA.ORCID 0000-0003-0560-8923
Yoshikazu HayashiPharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Peter W MarksCenter for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID 0000-0001-5619-4404
Russ B AltmanDepartments of Bioengineering and Genetics, Stanford University, Stanford, CA, USA.ORCID 0000-0003-3859-2905
Murray M LumpkinGlobal Health, Bill and Melinda Gates Foundation, Seattle, WA, USA.ORCID 0000-0002-8708-7617
Kathleen M GiacominiDepartment of Bioengineering and Therapeutic Sciences, University of California, San Francisco, San Francisco, CA, USA. kathy.giacomini@ucsf.edu.ORCID 0000-0001-8041-5430
Terrence F BlaschkeDepartments of Medicine and Molecular Pharmacology, Stanford University School of Medicine, Stanford, CA, USA.ORCID 0000-0001-5307-2620

Funding

FDA HHS U01 FD004979FDA HHS U01 FD005978World Health Organization 001
6 · The paper itself

Abstract

Requiring regional or in-country confirmatory clinical trials before approval of drugs already approved elsewhere delays access to medicines in low- and middle-income countries and raises drug costs. Here, we discuss the scientific and technological advances that may reduce the need for in-country or in-region clinical trials for drugs approved in other countries and limitations of these advances that could necessitate in-region clinical studies.

Indexed as

Developing CountriesDrug CostsDrug ApprovalDrug Development

Identifiers

PMID32727913
PMCPMC8158457

What OpenQuestion holds

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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.