Factors Affecting Success of New Drug Clinical Trials

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 factor...

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Bibliographic Details
Published inTherapeutic innovation & regulatory science Vol. 57; no. 4; pp. 737 - 750
Main Authors Kim, Eungdo, Yang, Jaehoon, Park, Sungjin, Shin, Kwangsoo
Format Journal Article
LanguageEnglish
Published Cham Springer International Publishing 01.07.2023
Springer Nature B.V
Subjects
Clinical trials
Communication
Drug development
Drug Evaluation
Drug Industry
Drug Safety and Pharmacovigilance
Medicine
Original Research
Pharmaceutical industry
Pharmaceuticals
Pharmacotherapy
Pharmacy
Statistical analysis
Success
Clinical trials
New Molecular Entity
Success factor
Biological drugs
New drug development
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Summary: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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ISSN:2168-4790
2168-4804
2168-4804
DOI:10.1007/s43441-023-00509-1