A systematic review of discontinued trials suggested that most reasons for recruitment failure were preventable

Matthias Briel; Kelechi Kalu Olu; Erik von Elm; Benjamin Kasenda; Reem Alturki; Arnav Agarwal; Neera Bhatnagar; Stefan Schandelmaier

doi:10.1016/j.jclinepi.2016.07.016

A systematic review of discontinued trials suggested that most reasons for recruitment failure were preventable

J Clin Epidemiol. 2016 Dec:80:8-15. doi: 10.1016/j.jclinepi.2016.07.016. Epub 2016 Aug 3.

Authors

Matthias Briel¹, Kelechi Kalu Olu², Erik von Elm³, Benjamin Kasenda⁴, Reem Alturki², Arnav Agarwal⁵, Neera Bhatnagar⁵, Stefan Schandelmaier⁶

Affiliations

¹ Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Spitalstrasse 12, 4031 Basel, Switzerland; Department of Clinical Epidemiology and Biostatistics, McMaster University, 1280 Main Street West, Hamilton, Ontario, L8S 4K1, Canada. Electronic address: matthias.briel@usb.ch.
² Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Spitalstrasse 12, 4031 Basel, Switzerland.
³ Cochrane Switzerland, Institute of Social and Preventive Medicine (IUMSP), Lausanne University Hospital, Route de la Corniche 10, Lausanne, 1010, Switzerland.
⁴ Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Spitalstrasse 12, 4031 Basel, Switzerland; Department of Oncology, University Hospital Basel, Petersgraben 4, Basel, 4031, Switzerland.
⁵ Department of Clinical Epidemiology and Biostatistics, McMaster University, 1280 Main Street West, Hamilton, Ontario, L8S 4K1, Canada.
⁶ Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Spitalstrasse 12, 4031 Basel, Switzerland; Department of Clinical Epidemiology and Biostatistics, McMaster University, 1280 Main Street West, Hamilton, Ontario, L8S 4K1, Canada.

PMID: 27498376
DOI: 10.1016/j.jclinepi.2016.07.016

Abstract

Objective: To collect and classify reported reasons for recruitment failure in discontinued randomized controlled trials (RCTs) and to assess reporting quality.

Methods: We systematically searched MEDLINE and EMBASE (2010-2014) and a previous cohort of RCTs for published RCTs reporting trial discontinuation due to poor recruitment. Teams of two investigators selected eligible RCTs working independently and extracted information using standardized forms. We used an iterative approach to classify reasons for poor recruitment.

Results: We included 172 RCTs discontinued due to poor recruitment (including 26 conference abstracts and 63 industry-funded RCTs). Of those, 131 (76%) reported one or more reasons for discontinuation due to poor recruitment. We identified 28 different reasons for recruitment failure; most frequently mentioned were overestimation of prevalence of eligible participants and prejudiced views of recruiters and participants on trial interventions. Few RCTs reported relevant details about the recruitment process such as how eligible participants were identified, the number of patients assessed for eligibility, and who actually recruited participants.

Conclusion: Our classification could serve as a checklist to assist investigators in the planning of RCTs. Most reasons for recruitment failure seem preventable with a pilot study that applies the planned informed consent procedure.

Keywords: Early termination of clinical trials; Poor recruitment; Randomized controlled trials as topic; Reasons for recruitment failure; Reporting quality; Systematic review.

Publication types

Review
Systematic Review

MeSH terms

Epidemiologic Research Design*
Humans
Lost to Follow-Up
Patient Selection*
Randomized Controlled Trials as Topic / methods*
Randomized Controlled Trials as Topic / statistics & numerical data*