The Case for Methodological Pluralism in Medical Science

Edwards, Sarah; Böck, Thomas; Palm, Ülo; Wang, Sally; Cheng, Glen; Wang, Lixia; Pitts, Peter J.

doi:10.1080/15265161.2020.1795516

Cited by 2 publications

(1 citation statement)

References 5 publications

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“…Third, since the data in this study are from controlled clinical trials, they do not accurately provide implications for clinical research in the real world. Recently, efforts have been made to derive clinical evidence using real world data (RWD), and it is expected that various problems such as securing subjects in clinical trials and lack of control groups, post-approval follow-up will be resolved [ 37 , 38 ]. For example, if more data related to clinical trials to use artificial intelligence (AI) such as machine learning can be used, a clinical trial execution strategy suitable for each organization's situation could be developed.…”

Section: Discussionmentioning

confidence: 99%

Factors Affecting Success of New Drug Clinical Trials

Kim

Yang

Park

et al. 2023

Ther Innov Regul Sci

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Clinical trials are an essential process in the development of new drugs. In spite of time-consuming processes and high costs, the overall success rate of clinical trials is only 7.9%, which is a high risk for biopharmaceutical companies. However, despite these huge risks, research on finding factors affecting clinical trials to overcome and manage to risks has been insufficient. Considering these characteristics of the pharmaceutical industry, this study investigated the factors affecting the success of sponsor-initiated clinical trials. The success factors investigated were categorized into four factors: quality of clinical trials, speed of clinical trials, relationship type, and communication. Logistic regression was performed to measure each factor by analyzing 24,295 cases of Phase 1 to 4 trials from ClinicalTrials.gov. Because of the analysis, the factors affecting the success of the clinical trials were varied according to each clinical phase and the drug types: New Molecular Entity (NME)/Biologics, and the success ratio in the quality variable affected the overall clinical trial phases. Additionally, the experience, speed, relationship type, and communication variables were also found to be statistically significant for the success of each phase and drug type.

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Section: Discussionmentioning

confidence: 99%