Subject enrollment into a clinical trial is one of the most important aspects that ensure the study will be completed within the timeframe intended. Although it seems like a straightforward and simple process, there are multiple inputs and process steps involved.
Finding the right patients:
For a busy clinical site – the kind that a sponsor needs to ensure good subject numbers – there may be 15,000 to 25,000 patients that are followed by the practice. The review of each patient to determine their fit to the study I/E criteria can be very time consuming. While electronic medical records are a great boon to this screening process – with most systems able to screen for patient subsets based on ICD-9 codes or medications prescribed –often the very complex I/E criteria require a far more detailed analysis of each ‘possible’ study subject’s health information to confirm their appropriateness. The best that most sites can do in this setting is to have the study criteria printed out for reference when each day’s patients visit the site with the hope that the busy nurse or PA who manages their visit will remember to quiz them on the study-related criteria.
What if the site had a specialist with medical background and thorough knowledge of the protocol who could capture the relevant patient subset from the EMR and review the medical record of each one identified to determine their likelihood to fit the study?
Getting patients consented to participate:
When the staff nurse happens to find a possible study candidate during a standard of care visit, a sudden need arises for an extra hour or two added to the appointment to work through the informed consent with the patient. No clinic visit is scheduled with a two-hour gap in between just in case it’s needed. Obtaining informed consent in a rushed and hectic fashion is not in accordance with regulatory guidelines, and may not give the patient a good understanding of the study or comfort regarding how their participation in the study will work out. In most cases the nurse or other site staff will need to schedule a return visit for the consent. Even getting this visit arranged can result in disruption to the smooth operations of the practice, not to mention disrupting the illness-encumbered life of the patient.
What if the site had a dedicated team to contact site patients who possibly fit criteria, schedule their appointments, meet them when they arrived and dedicate all the time necessary to explain the study and obtain their consent to participate?
Managing the many things that can occur during study enrollment:
If the nurse were really on the ball and able to find twenty potential subjects for the study and get them to make an appointment to return later to review and sign the consent form, how would she/he manage all of the communication and reminders needed to ensure all these patients remain interested and actually show up for the consenting visit, fasted as may be necessary, with a list of all medicines taken and fresh memory of study-impacting procedures that may have been done in the past at other healthcare providers? How will she/he manage those that don’t show up to ensure that they are contacted and arrangements made for a new appointment?
What if the site’s Research team tracked all identified patients, compiled their study-relevant data and presented it to the site’s physician investigator for approval, prepared and sent letters from the site to confirm the visit details, and made reminder calls to ensure they were planning to show up and came ready for consenting and study procedures to begin right away? What if they were there specifically to see each study patient, perform protocol procedures, answer questions about the study and schedule the next study visit with the subjects?
If the site has hired CTMG to manage the operational aspects of the study, all site staff can carry on their usual busy schedules confident that all of these demanding study-related tasks will be taken care of efficiently and thoroughly by their SSRO clinical research partner.