Evidence map›Paper›PMID 36572831›Full record

ArticleTherapeutic innovation & regulatory science2023

Awareness of Clinical Research Coordinators Toward Ethics and Protection of Clinical Trial Patients.

Zhen Peng, Yan Ma, Jumei Wang, Xiaoling Xu, Chongwei Wang, Yin Chen

Abstract read
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In one paragraph

Article in Therapeutic innovation & regulatory science, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
1.2field-weighted citation impact, top 21% of its field
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

1 citing paper in PubMed, 6 citations in OpenAlex.

  1. 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

6 authors at 1 institution in 1 country.

Zhen PengThe First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, 230001, Anhui, China.
Yan MaThe First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, 230001, Anhui, China.
Jumei WangThe First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, 230001, Anhui, China.
Xiaoling XuThe First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, 230001, Anhui, China.
Chongwei WangThe First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, 230001, Anhui, China.
Yin ChenThe First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, 230001, Anhui, China. chenyin@ustc.edu.cn.
University of Science and Technology of China · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeClinical research coordinators (CRCs) play an important role in the protection of clinical trial participants and maintenance of ethical standards. However, limited data are available on the ethical cognition of CRCs. Understanding the knowledge, attitude, and practices (KAP) of CRCs toward ethics is essential to protect study participants and improve their compliance.

methodsWe conducted a descriptive, cross-sectional, quantitative study at 20 hospitals in Anhui province of China. A self-administered questionnaire was completed by 435 CRCs conducting clinical trials.

resultsThe good knowledge, positive attitude, and good practice rates were 55.2%, 59.3%, and 79.5% respectively. Most CRCs (99.1%) were aware of the participants' rights. Only 127 (29.2%) and 140 (32.2%) CRCs were aware of measures to protect participants' rights and ethical guidelines regarding trials, respectively. In total, 59.6% of CRCs stated that ethical review might delay the start of a clinical trial. Marital status (odds ratio [OR] 0.47, 95% confidence interval [CI] 0.27-0.83), CRC work experience (OR 0.11, 95% CI 0.02-0.75), and educational background (OR 0.31, 95% CI 0.13-0.76) affected the knowledge of CRCs regarding ethics.

conclusionsSome deficiencies were observed in the ethical knowledge and behavior of CRCs. Interventions to improve the ethical training of CRCs regarding study participant protection, international guidelines, and the role of ethical committees are essential when conducting clinical trials. Validated instruments should be constructed to assess the effectiveness of ethical training and measure the KAP of CRCs toward ethics.

Indexed as

AttitudeResearch PersonnelCognitionCross-Sectional StudiesHumansSurveys and QuestionnairesClinical research coordinatorsClinical trialEthicsKnowledgeProtection

Identifiers

PMID36572831
OpenAlexW4312211212

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.