Monitor trial progress and accrual metrics

Monitor recruitment and retention plan activities and adjust when necessary

  • The Recruitment and Retention plan you wrote while Selecting and Preparing to Open the Trial was meant to be used. Look back at your plan. Is it being implemented as envisioned? What useful changes might be needed? Your willingness to judge existing efforts and your openness to making changes as needed is what matters most.

Monitor promotion activities and adjust when necessary

  • Are promotion activities going as intended? Are changes needed? Again, your openness to judging your own efforts and your willingness to adjust are key. 

Monitor evaluation goals, objectives, and activities

  • Check your Evaluation Plan within your Recruitment and Retention Plan. Are you collecting the right information to know if you are meeting your goals in a timely manner? If not, what should be changed: the plan, the recruitment, or tracking activities? 

Review trial accrual indicators against expected performance

  • This activity is a reminder to specifically check accrual performance as outlined in your Evaluation Plan and to use the data to make accrual performance judgments. 

Regularly assess the trial’s costs against its budget

  • In the spirit of aiming for “no surprises” (an AccrualNet™ theme), assess trial costs against your budget regularly. Discuss the assessment and thoughts on how the trial is performing and its value from a financial perspective. 

Monitor screening data for diverse and underserved populations

  • Historically, racial and ethnic minorities have been underrepresented in clinical research. Take time to specifically review plans and ask whether they reflect the racial and ethnic makeup of the community and are reaching these populations. Check whether screening data matches the proportion of participants from diverse and underserved populations found in your community. 

Monitor the impact of operations and logistics on trial accrual

  • You worked hard to remove logistical barriers as you prepared your Recruitment and Retention Plan. Check whether unforeseen operational or logistical issues have come up. 

Literature and Tools (104)

Image Representing Resource Type (Journal Article)
A randomized recruitment intervention trial in Parkinson's disease to increase participant diversity: early stopping for lack of efficacy.
Posted: Feb 22, 2013.
Tilley BC,Mainous AG 3rd,Elm JJ,Pickelsimer E,Soderstrom LH,Ford ME,Diaz VA,Siminoff LA,Burau K,Smith DW. Clin Trials. 2012 Apr. 9. 2. 188-97.
KEYWORDS: Knowledge/Attitudes/Beliefs, Logistics/Transportation, Underserved, Level of Clinical Trials Knowledge or Awareness, Staff Experience Level, Physician Champions, Provider-Patient Relationship, Attitudes, Minority Groups, Verbal Communications, Brochure or Flyer, Non-Cancer
Image Representing Resource Type (Journal Article)
National Surgical Adjuvant Breast and Bowel Project Study of Tamoxifen and Raloxifene trial: Advancing the science of recruitment and breast cancer risk assessment in minority communities.
Posted: Feb 13, 2013.
McCaskill-Stevens W,Wilson JW,Cook ED,Edwards CL,Gibson RV,McElwain DL,Figueroa-Moseley CD,Paskett ED,Roberson NL,Wickerham DL,Wolmark N. Clin Trials. 2013 Jan 18. [Epub ahead of print]
KEYWORDS: Language or Cultural Barriers, Staff Experience Level, Physician Champions, Women, Minority Groups, American Indian or Alaskan Native, Asian, Black or African-American, Hispanic or Latino, Verbal Communications, Radio, TV, Web, Print Media, Brochure or Flyer, Letter, Cancer, Prevention
Image Representing Resource Type (Journal Article)
Recruitment methods employed in the National Lung Screening Trial.
Posted: Jan 17, 2013.
Marcus PM,Lenz S,Sammons D,Black W,Garg K. J Med Screen. 2012 Jun. 19. 2. 94-102.
KEYWORDS: Staff Experience Level, Verbal Communications, Radio, TV, Print Media, Brochure or Flyer, Letter, Cancer, Screening
Image Representing Resource Type (Journal Article)
The Cost-Time Index: A new method for measuring the efficiencies of recruitment-resources in clinical trials.
Posted: Jan 17, 2013.
Ota KS,Friedman L,Ashford JW,Hernandez B,Penner AL,Stepp AM,Raam R,Yesavage JA. Contemp Clin Trials. 2006 Dec. 27. 6. 494-7.
KEYWORDS: Print Media, Brochure or Flyer, Non-Cancer
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

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