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

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      Publication date (Electronic):
      Journal: Contemporary Clinical Trials Communications
      Publisher: Elsevier
      Keywords: Clinical trials, Enrollment, Patient burden, Pharmaceutical trials, Retention, Recruitment

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          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.

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          What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies

          Alison McDonald, Rosemary Knight, Marion K Campbell … (2006)
          Background A commonly reported problem with the conduct of multicentre randomised controlled trials (RCTs) is that recruitment is often slower or more difficult than expected, with many trials failing to reach their planned sample size within the timescale and funding originally envisaged. The aim of this study was to explore factors that may have been associated with good and poor recruitment in a cohort of multicentre trials funded by two public bodies: the UK Medical Research Council (MRC) and the Health Technology Assessment (HTA) Programme. Methods The cohort of trials was identified from the administrative databases held by the two funding bodies. 114 trials that recruited participants between 1994 and 2002 met the inclusion criteria. The full scientific applications and subsequent trial reports submitted by the trial teams to the funders provided the principal data sources. Associations between trial characteristics and recruitment success were tested using the Chi-squared test, or Fisher's exact test where appropriate. Results Less than a third (31%) of the trials achieved their original recruitment target and half (53%) were awarded an extension. The proportion achieving targets did not appear to improve over time. The overall start to recruitment was delayed in 47 (41%) trials and early recruitment problems were identified in 77 (63%) trials. The inter-relationship between trial features and recruitment success was complex. A variety of strategies were employed to try to increase recruitment, but their success could not be assessed. Conclusion Recruitment problems are complex and challenging. Many of the trials in the cohort experienced recruitment difficulties. Trials often required extended recruitment periods (sometimes supported by additional funds). While this is of continuing concern, success in addressing the trial question may be more important than recruitment alone.
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            Lexicon-Based Methods for Sentiment Analysis

            Maite Taboada, Julian Brooke, Milan Tofiloski … (2011)
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              The prevention and handling of the missing data

              Hyun Ki Kang (2013)
              Even in a well-designed and controlled study, missing data occurs in almost all research. Missing data can reduce the statistical power of a study and can produce biased estimates, leading to invalid conclusions. This manuscript reviews the problems and types of missing data, along with the techniques for handling missing data. The mechanisms by which missing data occurs are illustrated, and the methods for handling the missing data are discussed. The paper concludes with recommendations for the handling of missing data.
              Article 0 comments Cited 323 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                David B. Fogel
                Journal
                Journal ID (nlm-ta): Contemp Clin Trials Commun
                Journal ID (iso-abbrev): Contemp Clin Trials Commun
                Title: Contemporary Clinical Trials Communications
                Publisher: Elsevier
                ISSN (Electronic): 2451-8654
                Publication date PMC-release: 07 August 2018
                Publication date Collection: September 2018
                Publication date (Electronic): 07 August 2018
                Volume: 11
                Pages: 156-164
                Affiliations
                [1]Trials.ai, 4520 Executive Dr., Suite 200, San Diego, CA, 92121, United States
                Article
                Publisher ID: S2451-8654(18)30069-3
                DOI: 10.1016/j.conctc.2018.08.001
                PMC ID: 6092479
                PubMed ID: 30112460
                SO-VID: 2f9316ab-b6ec-4472-86f0-fb5737e0f363
                Copyright © © 2018 The Author
                License:

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                Date received : 29 May 2018
                Date revision received : 19 July 2018
                Date accepted : 6 August 2018
                Categories
                Subject: Article

                Keywords: clinical trials,enrollment,patient burden,pharmaceutical trials,retention,recruitment
                Data availability:
                Keywords: clinical trials, enrollment, patient burden, pharmaceutical trials, retention, recruitment

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