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Review
. 2018 Aug 7:11:156-164.
doi: 10.1016/j.conctc.2018.08.001. eCollection 2018 Sep.

Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: A review

David B Fogel  1
Affiliations
Review

Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: A review

David B Fogel. Contemp Clin Trials Commun. .

Abstract

Clinical trials are time consuming, expensive, and often burdensome on patients. Clinical trials can fail for many reasons. This survey reviews many of these reasons and offers insights on opportunities for improving the likelihood of creating and executing successful clinical trials. Literature from the past 30 years was reviewed for relevant data. Common patterns in reported successful trials are identified, including factors regarding the study site, study coordinator/investigator, and the effects on participating patients. Specific instances where artificial intelligence can help improve clinical trials are identified.

Keywords: Clinical trials; Enrollment; Patient burden; Pharmaceutical trials; Recruitment; Retention.

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References

    1. Abraha I., Cherubini A., Cozzolino F., De Florio R., Luchetta M.L., Rimland J.M., Folletti I., Marchesi M., Germani A., Orso M., Eusebi P., Montedori A. Deviation from intention to treat analysis in randomised trials and treatment effect estimates: meta-epidemiology study. BMJ. 2015;350:h2445. - PMC - PubMed
    1. Alam H., Hartono R., Kumar A., Rahman F., Tarnikova Y., Wilcox C. Proc 7th Int Conf Doc Anal Recog. IEEE Computer Society; Edinburgh, Scotland: 2013. Web page summarization for handheld devices: a natural language approach; pp. 1153–1157.
    1. Audet L.A., Bourgault P., Rochefort C.M. Associations between nurse education and experience and the risk of mortality and adverse events in acute care hospitals: systematic review of observational studies. Int. J. Nurs. Stud. 2018;80:128–146. - PubMed
    1. Babbs C.F. Choosing inclusion criteria that minimize the time and cost of clinical trials. World J. Meth. 2014;4:109–122. - PMC - PubMed
    1. Baquet C.R., Elison G.L., Mishra S.I. Analysis of Maryland cancer patient participation in national cancer institute-supported cancer treatment clinical trials. J. Clin. Oncol. 2008;26:3380–3386. - PMC - PubMed