Literature DB >> 32056053

Patients' perspectives on participation in clinical trials and subsequent ethical challenges in a hospital setting in Jordan.

Lobna Gharaibeh1, Hanan Sartawi2, Karem Alzoubi3, Tareq Juma2, Diana Ayyad2, Samah Sartawi2.   

Abstract

Background The number of global clinical trials is increasing. Recruitment rate in clinical trials is a challenging task that affects sample size, power of the study, and adequate representation of the targeted population. An understanding of the worries and reasons why patients may refrain from participation in trials may lead to improved enrollment rates. Objectives To assess the rate of patients who are willing to participate in clinical trials, and aspects that might have an impact on the patients' willingness to participate. Setting Government tertiary hospital in Jordan. Methods This is a cross-sectional study. Patients were interviewed by pharmacists in different clinics in a tertiary hospital and information was collected using a data collection sheet. Main outcome measure Factors that might predict the inclination of a patient to participate in clinical trials, and the rate of willingness to participation in randomized controlled trials in cancer patients compared to non-cancer patients. Results A total of 1193 participants were enrolled in the study, one hundred and thirty-five participants (11.3%) had cancer and 80% of the participants had at least one chronic medical condition. Majority of patients (n = 882, 73.9%) believed that trials were safe and 1106 (92.7%) patients thought they were important. Age, education level, income, having cancer or any chronic medical condition, and degree of control of chronic diseases were statistically significant predictors of the willingness of patients to participate in trials. Patients with cancer had a higher rate of acceptance to participation in randomized controlled trials compared to non-cancer patients, 80.0% versus 62.4%, p value < 0.001. Conclusion In general, almost two-thirds of patients were willing to participate in clinical trials, with a higher rate in cancer patients. Factors such as education level, income, and extent of control of medical conditions that might refrain patients from enrollment in trials will lower recruitment rate and must be addressed and taken into consideration before launching clinical trials.

Entities:  

Keywords:  Developing country; Ethics; Jordan; Perspectives; Randomized controlled trials (RCT)

Year:  2020        PMID: 32056053     DOI: 10.1007/s11096-019-00959-4

Source DB:  PubMed          Journal:  Int J Clin Pharm


  29 in total

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Review 2.  Clinical trials in developing countries - ethical considerations.

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Journal:  Psychiatr Danub       Date:  2018-09       Impact factor: 1.063

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Journal:  IRB       Date:  2017 Jul-Aug

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Journal:  Ann Oncol       Date:  2000-08       Impact factor: 32.976

6.  Women's Autonomy and Informed Consent in Microbicides Clinical Trials.

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Journal:  Perspect Clin Res       Date:  2010-07

8.  Sex based subgroup differences in randomized controlled trials: empirical evidence from Cochrane meta-analyses.

Authors:  Joshua D Wallach; Patrick G Sullivan; John F Trepanowski; Ewout W Steyerberg; John P A Ioannidis
Journal:  BMJ       Date:  2016-11-24

9.  Clinical trials from the patient perspective: survey in an online patient community.

Authors:  Pronabesh DasMahapatra; Priya Raja; Jeremy Gilbert; Paul Wicks
Journal:  BMC Health Serv Res       Date:  2017-02-27       Impact factor: 2.655

10.  Challenges in recruitment and retention of clinical trial subjects.

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Journal:  Perspect Clin Res       Date:  2016 Jul-Sep
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  3 in total

1.  Perceptions and attitudes toward participation in clinical research in the Eastern Mediterranean Region: A systematic review.

Authors:  Mohamed Aabdien; Ibtihal Abdallah; Mohamed Iheb Bougmiza; Timo Siepmann; Ben Illigens
Journal:  Medicine (Baltimore)       Date:  2022-08-19       Impact factor: 1.817

2.  Factors impacting participation in research during the COVID-19 pandemic: results from a survey of patients in the ophthalmology outpatient department.

Authors:  Dalia Abdulhussein; Timothy E Yap; Haider Manzar; Serge Miodragovic; Francesca Cordeiro
Journal:  Trials       Date:  2022-09-30       Impact factor: 2.728

3.  Knowledge, attitude, and perception of public about participation in COVID-19 clinical trials: a study from Egypt and Saudi Arabia.

Authors:  Khaled Elshammaa; Nouran Hamza; Emad Elkholy; Ahmed Mahrous; Mohamed Elnaem; Mahmoud Elrggal
Journal:  Saudi Pharm J       Date:  2022-01-19       Impact factor: 4.562

  3 in total

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