PRO Tip of the Month

Planning Patient Enrollment for Pharmaceutical Studies

  1. Know the population you want to study and know the number of subjects who would be eligible to participate.

    1. Pharmaceutical studies require a fair amount of pre-regulatory work on both coordinator and PI ends, which is a large amount of time to dedicate to a study.  So you want to make sure you can meet the enrollment goals before committing to a pharma study.

    2. It's worthwhile to do pre-study feasibility and run or request an Epic report on how many patients you saw last year that fall into the study inclusion/exclusion criteria. You may need to use ICD-10/CPT codes to help fine-tune this report.

  2. Ensure you have engaged team members to participate on the study.  Hold staff meetings with all study personnel to get everyone on the same page prior to starting the study. Be sure to present the study to the clinical area where patients would be recruited from.

  3. If you spend the time and effort to open the study, ensure you have the numbers to meet the specific aims and objectives of the study, which includes enrollment goals and staying within the agreed upon study budget.