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Accrual Stages

OCRA Recruiting process

Stage 1
Developing a Study

Successful clinical study accrual begins at the protocol writing stage. The earlier in the study's lifecycle that you plan for accrual, the more likely the study is to recruit.

  1. Consider National and Local Stakeholder Enthusiasm for the Study
    • Evaluate the level of scientific interest in the study from the field and your institution
    • Evaluate the level of commitment from the field and your institution with an eye toward study feasibility
    • Check for competing studies at your institution and nationally
  2. Evaluate the Study for Recruitment Feasibility
    • Determine the availability of the study population at your institution and nationally
    • Assess and minimize the study burden on patients
    • Use feasibility studies to test recruitment strategies
  3. Choose Study Sites Carefully
    • Evaluate the recruitment histories of potential sites
    • Determine the available resources of potential sites (e.g., staffing or facilities)
    • Look at the potential sites' competing studies
    • Look at the sites' interest level in the study—both scientific interest and their thoughts on feasibility
  4. Prepare Study-Specific Materials
    • Prepare participant-friendly informed consent document
    • Create study-specific materials for participants
    • Ensure that materials are culturally appropriate

Stage 2
Selecting & Preparing to Open a Study

“Should this clinical study be opened at my site?” This is an important question, and the answer isn't always “Yes!”

  1. Evaluate Your Institution's Study Portfolio and Participant Population
    • Confirm that the study's scientific question is relevant and of interest to your institution
    • Assess where the study fits within your institution's portfolio of open studies and check for competing studies
    • Verify that there are no conflicts of interest in this study
    • Ensure that the study matches your patient population
    • Assess the financial burden the study will place on participants
    • Determine the level of study burden on participants and their support systems
  2. Assess Your Institution's Infrastructure and Resources
    • Obtain feedback on the study from key staff
    • Assess the financial burden of the study on your institution
    • Assess the capacity of your institution to conduct the study
    • Determine if you have adequate staffing levels
  3. Ensure Stakeholder Commitment
    • Ensure a clinical “champion”
    • Ensure staff buy-in
    • Ensure buy-in from experts/specialists who are needed to implement the study
    • Confirm buy-in at the institutional level
  4. Create a Clinical Studies Friendly Environment
    • Provide a comfortable physical environment for participants in studies
    • Understand participants' perceptions of being part of a clinical study
    • Establish an efficient work environment to effectively conduct clinical studies
    • Discuss clinical study options with every patient
    • Ensure all staff members are trained in conducting clinical studies
    • Ensure staff is aware of your institution's available studies
  5. Plan Internal Processes to Conduct the Study
    • Complete a study start-up checklist
    • Plan study logistics and scheduling
    • Dedicate staff and budget to recruitment in the beginning
    • Identify “go-to” research staff for the study
    • Provide study-specific training to staff
    • Pre-authorize insurance or develop alternate payment options for the study
    • Implement information technology (IT) processes for the study
  6. Write a Comprehensive Recruitment and Retention Plan
    • Integrate recruitment and retention plans with institutional activities
    • Determine how to screen and identify potential participants
    • Prepare site-specific study promotional materials for potential participants
    • Address diverse and underserved populations
    • Include plans for community outreach
    • Include plans to work with referring physicians
    • Write a study-specific Evaluation Plan
    • Set milestones, metrics, goals, back-up plans
    • Set accrual performance thresholds (e.g., time from study opening to first participant enrollment)

Stage 3
Recruiting and Communicating With Participants

The study is open for enrollment. Now what? You should be finding, meeting, and establishing relationships with participants. But how?

  1. Engage Intermediaries to Aid Accrual
    • Assure that plans to reach referring physicians are being executed
    • Assure community outreach plans are being executed
    • Generate advocate buy-in
    • Engage patient navigators
  2. Identify Potentially Eligible Participants
    • Query your institution's paper or electronic medical record system(s)
    • Follow up with potentially eligible but non-consented individuals
    • Identify and report on participant non-adherence indicators
  3. Engage Participants in the Informed Consent Process
    • Use plain language
    • Use participant-friendly materials
    • Present the study in a culturally appropriate manner
    • Seek the help of translators when needed
    • Emphasize the key role of the physician presenting the study
    • Present the study in a balanced manner—both pros and cons
    • Provide continued support as people consider their decision to participate and continue on the study
    • Manage communication of screening results and failures
    • Be aware of and monitor regulatory issues such as HIPAA regulations
  4. Consider Participant Financial Issues
    • Establish relationships with insurance companies to facilitate coverage
    • Track insurance coverage concerns for the study
    • Work with specialists to identify alternative financing if a potential participant has no insurance
  5. Maintain the Morale and Interest of Staff, Participants and Their Families
    • Watch for early signs of non-adherence and provide support to meet needs
    • Keep in touch with participants on studies (e.g., through newsletters or reminders)
    • Offer support groups, participant networking, lists of local and online support resources
    • Conduct satisfaction surveys with study participants
    • Regularly update staff on study accrual
    • Encourage staff to provide feedback about the study
  6. Update Participants Regarding Study Related Events and Results
    • Keep contact lists current and note the best way to communicate with individual participants (e.g., through email, newsletter, telephone call)
    • Monitor media regularly and have a plan in place to respond to study-relevant media stories (to participants, to the media, and to stakeholders)
    • Have a plan for notifying participants/families, staff, and stakeholders if the study is put on hold or closes unexpectedly

More Information on Recruiting and Communicating With Participants

Stage 4
Implementing the Study

Managing recruitment and retention is a vital component of overall study management. As recruitment, enrollment, and retention activities are underway, the study team must keep communications and logistics running smoothly. A Recruitment and Retention Plan can help.

  1. Communicate Regularly with Stakeholders and Referring Providers
    • Conduct regular staff meetings to discuss study accrual
    • Regularly communicate the study's accrual status to key staff/stakeholders and seek feedback
  2. Monitor Study Progress and Accrual Metrics
    • Monitor recruitment and retention plan activities and adjust when necessary
    • Monitor promotion activities and adjust when necessary
    • Monitor evaluation goals, objectives, and activities
    • Review study accrual indicators against expected performance
    • Regularly assess the study's costs against its budget
    • Monitor screening data for diverse and underserved populations
    • Monitor the impact of operations and logistics on study accrual
  3. Implement Alternative Recruitment Strategies When Accrual Milestones Are Not Achieved
    • Use data to decide whether to make changes or close the study
    • If changes are made, document expectations and monitor over a specific timeline
    • Determine if the state of the science has changed and accrual is unachievable

Stage 5
Evaluating Accrual and Reporting Lessons Learned

The closing of a study is a time to take stock—to understand both what went well and what did not. Use the lessons learned to build the knowledge and capacity of your team and to strengthen future recruitment efforts.

  1. Analyze The Study's Accrual Data for Lessons Learned
    • Review accrual data and discern lessons learned to improve future studies
    • Determine the study's value to your institution
    • Analyze data from a terminated study
  2. Report and Share Accrual Experiences with Others
    • Prepare and submit a summary of study-specific accrual findings and lessons learned to key stakeholders
    • Document and submit your experiences and findings to journals and at professional meetings

*Source attribution: This information was adapted from the National Cancer Institute’s AccuralNet portal.