Evidence map›Paper›PMID 30621692›Full record

ArticleBMC medical ethics2019

Participants' awareness of ethical compliance, safety and protection during participation in pharmaceutical industry clinical trials: a controlled survey.

Gerardo González-Saldivar, René Rodríguez-Gutiérrez, Jose Luis Viramontes-Madrid, Alejandro Salcido-Montenegro, Neri Alejandro Álvarez-Villalobos, Victoria González-Nava, José Gerardo González-González

Abstract readControlled Clinical Trial
In one paragraph

Article in BMC medical ethics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. 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

7 authors.

Gerardo González-SaldivarOphthalmology Division, Fundación Hospital Nuestra Señora de la Luz, IAP, Ciudad de México, Mexico.
René Rodríguez-GutiérrezEndocrinology Division, Department of Internal Medicine, "Dr. José E. González" University Hospital, Universidad Autonoma de Nuevo Leon, 64460, Monterrey, Mexico.
Jose Luis Viramontes-MadridInstituto Nacional de Salud Pública, Cuernavaca, Morelos, Mexico.
Alejandro Salcido-MontenegroEndocrinology Division, Department of Internal Medicine, "Dr. José E. González" University Hospital, Universidad Autonoma de Nuevo Leon, 64460, Monterrey, Mexico.
Neri Alejandro Álvarez-VillalobosKnowledge and Evaluation Research Unit in Endocrinology, Mayo Clinic, Rochester, MN, 55905, USA.
Victoria González-NavaEndocrinology Division, Department of Internal Medicine, "Dr. José E. González" University Hospital, Universidad Autonoma de Nuevo Leon, 64460, Monterrey, Mexico.
José Gerardo González-GonzálezEndocrinology Division, Department of Internal Medicine, "Dr. José E. González" University Hospital, Universidad Autonoma de Nuevo Leon, 64460, Monterrey, Mexico. jgerardo@meduanl.com.ORCID 0000-0002-6609-9483

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe rapid increase of industry-sponsored clinical research towards developing countries has led to potentially complex ethical issues to assess. There is scarce evidence about the perception of these participants about the ethical compliance, security, and protection. We sought to evaluate and contrast the awareness and perception of participants and non-participants of industry-sponsored research trials (ISRT) on ethical, safety, and protection topics.

methodsA Cases-control survey conducted at twelve research sites in México. Previous and current participants of ISRT (cases) as well as non-participants (controls) with one of four chronic diseases, were asked to complete the survey which focused on ethical compliance and protection issues of ISRT, and the perception of participating in a trial.

resultsA total of 604 cases and 604 controls were surveyed. Cases significantly answered that ethics committees are aware of what is happening in studies (50.5% vs. 33.8%, P = ≤ 0.001), and that medical care of industry-sponsored research trials is better than their usual medical care (77.2% vs. 38.2%, P = < 0.001). The same proportion of cases and controls thought patients must receive economical reimbursement for participating in a research study (49.5% vs. 53.1%, P = 0.205). The informed consent of the pharmaceutical clinical trial was fully read by 90.4% of the cases. Most cases were satisfied or very satisfied with their overall study participation (35.6 and 62.3%, respectively).

conclusionPrevious and current participants of industry-sponsored research trials have a more positive attitude towards ethics committees, the quality of medical care of the research trials, and the main purpose of economical reimbursements, when compared to non-participants.

Indexed as

AwarenessDrug IndustryEthics Committees, ResearchAdultAgedCase-Control StudiesConflict of InterestEthical ReviewFemaleGuidelines as TopicHuman ExperimentationHumansInformed ConsentMaleMexicoMiddle AgedClinical trialsEthics committeesGood clinical practicesPerceptionPharmaceutical industry

Identifiers

PMID30621692
PMCPMC6323663

What OpenQuestion holds

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Registered trials

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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.