Implement alternative recruitment strategies when accrual milestones are not achieved

Use data to decide whether to make changes or close the trial

  • For better or worse, everything from the pressure of competition to the joy of discovery plays a role in clinical trial work. But, when it comes to deciding whether a trial is accruing well enough and remains feasible, data should play the central role. Be willing to ask the tough question, “Can this study be saved and at what cost?”

If changes are made, document expectations and monitor over a specific timeline

  • Your team may assess a trial with major accrual challenges and determine that it indeed remains feasible or is meaningful enough to keep active. If you make this choice, plan on how best to improve recruitment and set new goals and a specific timeline for meeting them. At the appointed time, reassess.

Determine if the state of the science has changed and accrual is unachievable

  • Most trials take place over a fairly long time period. During that time, your team should keep up with the relevant science. Perhaps new findings, treatments, or approaches mean that your trial cannot accrue as hoped.

Literature and Tools (30)

Image Representing Resource Type (Journal Article)
Developing a survey of barriers and facilitators to recruitment in randomized controlled trials.
Posted: Dec 18, 2012.
Kaur G,Smyth RL,Williamson P. Trials. 2012 Nov 21. 13. 1. 218. 2012 Nov 21. [Epub ahead of print]
KEYWORDS: Knowledge/Attitudes/Beliefs, Language or Cultural Barriers, Logistics/Transportation, Low Literacy, Non-English Speaking, Cost/Insurance, Remuneration, Incentives, Staff Experience Level, Physician Champions, Provider-Patient Relationship, International, Institutional Issues, Inadequate Staffing, Eligibility, Placebo, Study Burden, Financial Incentives, Non-Cancer, Cancer
Image Representing Resource Type (Staff Education Materials)
Assessing Effectiveness of Minority Recruitment Efforts
Posted: Nov 14, 2012.
EMPACT (Enhancing Minority Participation in Clinical Trials).
KEYWORDS: Language or Cultural Barriers, Minority Groups
Image Representing Resource Type (Journal Article)
Clinical trial implementation and recruitment: Lessons learned from the early closure of a randomized clinical trial.
Posted: Jan 27, 2012.
Peters-Lawrence MH, Bell MC, Hsu LL, Osunkwo I, Seaman P, Blackwood M, Guillaume E, Bellevue R, Krishnamurti L, Smith WR, Dampier CD, Minniti CP, for the Sickle Cell Disease Clinical Research Network (SCDCRN). Contemp Clin Trials. 2012 Mar. 33. 2. 291-7.
KEYWORDS: Knowledge/Attitudes/Beliefs, Provider-Patient Relationship, Inadequate Staffing, Eligibility, Provider Influence, Black or African-American, Non-Cancer
Image Representing Resource Type (Journal Article)
Impact of a Multi-Disciplinary Patient Education Session on Accrual to a Difficult Clinical Trial: The Toronto Experience with the Surgical Prostatectomy Versus Interstitial Radiation Intervention Trial.
Posted: Dec 21, 2011.
Wallace K, Fleshner N, Jewett M, Basiuk J, Crook J. J Clin Oncol. 2006 Sep 01. 24. 25. 4158-62.
KEYWORDS: Knowledge/Attitudes/Beliefs, International, Randomization, Consent, Men, Verbal Communications, Cancer
Image Representing Resource Type (Meeting Abstract)
Clinical Trial Recruitment and Retention: Lessons Learned from Multiethnic Cervical Cancer Survivorship Trials
Posted: Sep 20, 2011.
Wenzel L.. University of California, Irvine. NCI ASCO Cancer Trial Accrual Symposium: Science and Solutions. 2010 Apr 29. Bethesda, MD.
KEYWORDS: Language or Cultural Barriers, Non-English Speaking, Women, Minority Groups, Hispanic or Latino, Cancer

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