Challenges in the design, conduct, analysis, and reporting in randomized clinical trial studies: A systematic review

Varse, Fatemeh; Janani, Leila; Moradi, Yousef; Solaymani‐Dodaran, Masoud; Baradaran, Hamid Reza; Rimaz, Shahnaz

doi:10.47176/mjiri.33.37

Cited by 8 publications

(10 citation statements)

References 34 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In phase 3 clinical trials, labor accounted for 37% of total costs, and outsourcing accounted for 22% ( 28 ). Clinical trials encounter challenges such as cost and staff shortages ( 29 , 30 ), and these barriers are the same for investigator- and industry-initiated clinical trials ( 29 ). In addition, the electronic data capture (EDC) system may reduce data collection time using a paper case report form (CRF) ( 31 ), and it is further suggested that the EDC will improve data collection accuracy ( 32 ).…”

Section: Discussionmentioning

confidence: 99%

“…Patient enrollment is also a vital aspect in the success of clinical research; however, only 31% of clinical trials have achieved their target patient count. In addition, approximately 45% of clinical trials have enrolled less than 80% of their target number of patients ( 34 ), making patient enrollment a barrier to clinical trial success ( 29 , 30 ). Collaboration with clinical research assistants such as CRCs is indispensable for efficient patient enrollment and requires funding.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

The association between research funding status and clinical research papers’ citation impact in Japan: A cross-sectional bibliometric study

Morisawa

Nishizaki²,

Devos³

et al. 2022

Front. Med.

View full text Add to dashboard Cite

IntroductionStudies have not sufficiently clarified the differences in citation impact between funded and non-funded clinical research papers. Hence, this study seeks to evaluate the relation between research funding status and clinical research papers’ citation impact in different research fields using multiple evaluation indices.MethodsIn this cross-sectional bibliometric study, clinical research papers published by core clinical research hospitals in Japan were compared retrospectively in terms of times cited (TC), category normalized citation impact (CNCI), citation percentile (CP), journal impact factor (JIF), the Software to Identify, Manage, and Analyze Scientific Publications (SIGAPS) category, and whether they were the funded clinical research. The association between research funding status or the SIGAPS category and CNCI ≥ 2 was analyzed using logistic regression analysis.Results11 core clinical research hospitals published 553 clinical research papers, of which 120 were non-funded and 433 were funded (public institution-funded and industry-funded). The study found that funded clinical research papers (public institution-funded and industry-funded) had significantly higher TC, CNCI, CP, and JIF than non-funded ones [TC: 8 (3–17) vs. 14 (8–31), p < 0.001; CNCI: 0.53 (0.19–0.97) vs. 0.87 (0.45–1.85), p < 0.001; CP: 51.9 (24.48–70.42) vs. 66.7 (40.53–88.01), p < 0.001; JIF: 2.59 (1.90–3.84) vs. 2.93 (2.09–4.20) p = 0.008], while the proportion of A or B rank clinical research papers of the SIGAPS category was not significantly different between the two groups (30.0 vs. 34.9%, p = 0.318). In the logistic regression analysis, having a CNCI ≥ 2 was significantly associated with research funding (public institution-funded and industry-funded) and publication in A or B rank journals of the SIGAPS category [research funding: Estimate 2.169, 95% confidence interval (CI) 1.153–4.083, p = 0.016; SIGAPS category A/B: Estimate 6.126, 95% CI 3.889–9.651, p < 0.001].ConclusionAnalysis via multiple indicators including CNCI and the SIGAPS category, which allows for a comparison of the papers’ citation impact in different research fields, found a positive relation between research funding status and the citation impact of clinical research papers.

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

The association between research funding status and clinical research papers’ citation impact in Japan: A cross-sectional bibliometric study

Morisawa

Nishizaki²,

Devos³

et al. 2022

Front. Med.

View full text Add to dashboard Cite

show abstract

“…It is not surprising therefore that inadequate stakeholder engagement or education has been reported by participants as one key factor affecting trust in clinical trials conduct. It has been largely reported that lack of knowledge and understanding resulting from poor community engagement negatively affects research activities [21].…”

Section: Discussionmentioning

confidence: 99%

Factors affecting trust in clinical trials conduct: Views of stakeholders from a qualitative study in Ghana

Chatio

Ganle

Adongo

et al. 2022

Preprint

View full text Add to dashboard Cite

Introduction: Globally, there are signs of declining public trust in science, especially in biomedical research. In Ghana, there are equally signs of public distrust in the conduct of biomedical research in Ghana. Typical examples are the unsuccessful conduct of the Ebola vaccine trial and the initial refusal of parents to allow their children to receive the recently piloted malaria vaccine in Ghana. Therefore, this study explored stakeholders’ views on factors affecting trust in clinical trials conduct in Ghana. Methods: This was a cross-sectional exploratory study using qualitative research approach. Forty-eight in-depth interviews and Key informant interviews were conducted with stakeholders. Purposive sampling technique was used to select participants. All the interviews were recorded, transcribed and coded into main and sub-themes using QSR Nvivo 12 software to aid thematic analysis. Results: Overall, participants saw the need for the conduct of clinical trials in Ghana because clinical trial studies enable scientists to come out with effective medicines for the management of diseases. Pre-implementation factors such as inadequate stakeholder engagement, rumours and negative influence affected trust. Implementation factors such as perceived risks about clinical trials medicines, apprehensions on drawing and use of blood samples, poor informed consent administration and perceived no illness all negatively affected trust in clinical trials conduct. Conclusion: Trust is a fundamental factor affecting a successful conduct of clinical trials. Thus, there is need for collective efforts by all stakeholders including research institutions and clinical trial regulatory bodies to take the issue of trust in clinical trials conduct seriously.

show abstract

“…Randomized controlled trials are essential for researching effectiveness of medical treatments [1]. However, designing and completing these may include considerable barriers such as ethical, financial, and personnel issues [2]. Especially the recruitment phase has proven challenging for many trials [2] [3] [4].…”

Section: Introductionmentioning

confidence: 99%

“…However, designing and completing these may include considerable barriers such as ethical, financial, and personnel issues [2]. Especially the recruitment phase has proven challenging for many trials [2] [3] [4]. Part of this may be explained by rigid legislation when conducting trials with patient involvement.…”

Section: Introductionmentioning

confidence: 99%

Melatonin for Pre- and Postoperative Pain and Anxiety: A Cancelled Clinical Trial

Andersen¹,

Madsen²,

Zetner³

et al. 2021

IJCM

View full text Add to dashboard Cite

Challenges in the design, conduct, analysis, and reporting in randomized clinical trial studies: A systematic review

Cited by 8 publications

References 34 publications

The association between research funding status and clinical research papers’ citation impact in Japan: A cross-sectional bibliometric study

The association between research funding status and clinical research papers’ citation impact in Japan: A cross-sectional bibliometric study

Factors affecting trust in clinical trials conduct: Views of stakeholders from a qualitative study in Ghana

Melatonin for Pre- and Postoperative Pain and Anxiety: A Cancelled Clinical Trial

Contact Info

Product

Resources

About