Evidence map›Paper›PMID 38082120›Full record

ArticleDrug safety2024

Promoting Collaboration of Regulators and Patients in Improving Drug Safety and Regulatory Decision Making.

Yoong Khean Khoo, John C W Lim, Wei Chuen Tan-Koi, Nokuthula Sikhethiwe Kitikiti, Ai Ling Sim-Devadas

Abstract read
PubMed Publisher
In one paragraph

Article in Drug safety, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
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.

Yoong Khean Khoo *Centre of Regulatory Excellence, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore. khooyk@duke-nus.edu.sg.
John C W Lim *Centre of Regulatory Excellence, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore.ORCID 0000-0002-4286-4937
Wei Chuen Tan-KoiCentre of Regulatory Excellence, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore.
Nokuthula Sikhethiwe KitikitiCentre of Regulatory Excellence, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore.
Ai Ling Sim-DevadasLee Kong Chian School of Medicine, Nanyang Technological University, 11 Mandalay Road, Singapore, 308232, Singapore.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Pharmacovigilance involves a continuous process of evaluating, monitoring and communicating the safety profile of a medicine throughout its life cycle. This process involves a range of stakeholders, including national regulatory authorities, industry, health organisations, healthcare providers and patients. Although patients are the end users of medicines and experts in their medical conditions, patient involvement is still nascent in the Asia-Pacific region. While there are positive examples and encouraging trends, several key challenges currently hinder systemic patient involvement in drug safety and regulatory decision making. Systemic issues such as a lack of formalised frameworks or platforms, underdeveloped communication and information exchange channels, and paternalistic health systems constrain greater patient involvement and collaborative regulator-patient activities. Addressing these challenges will greatly advance collaboration among regulators, patients, and patient advocates to enhance drug safety and regulatory decision making.

Indexed as

PatientsPharmacovigilanceAsiaCommunicationDecision MakingHumans

Identifiers

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.